Contents. Vitature User Guide. What Is Vitature? System Requirements Logging In General Settings... 5

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1 Contents What Is Vitature?... 2 System Requirements... 3 Logging In... 4 General Settings... 5 Organization Administrator, Settings... 5 Non-Organization Administrator, Settings... 9 The Homepage... 9 Search and Navigation Creating Material Records Navigating Material Records Building Material Specifications Navigating Supplier Records The Supplier Company, Material, and Site Qualification Process Creating and Navigating Supplier Material Records Record Statuses Archiving, Exporting, Digital Audit Trails, and Favoriting Comparing Your Data Sheet Values Against a Supplier s Vitature Smart Ingredient Taxonomy Vitature Science Database Uploading Studies and Associating Studies with Records Vitature Product Research Database Page 1

2 Bulk Formulas Bulk Formula Calculations Submitting Questions and Feedback Glossary What Is Vitature? Vitature is the cloud-based platform created by Healthnotes for managing compliance between raw material suppliers and finished goods manufacturers. Vitature increases efficiencies by centralizing, digitizing, and standardizing material data; speeds time-to-market by automating material information exchange; and reduces regulatory risk by tracking material data and documents and supporting label claim substantiation. Vitature was built from product research and through testing done with hundreds of experts in the dietary supplement industry. This insight, coupled with our expertise in science and retail and our passion for increasing transparency and compliance across the supply chain, puts us in a unique position to offer a solution that simplifies product development. Vitature s record-keeping system centers on creating and managing records for suppliers, materials, supplier materials, sites, and bulk formulas. See the chart below for definitions of these record types and their relationships (Figure 1). Page 2

3 Figure 1: Vitature Record Types and Relationships For your convenience, we ve included a glossary of commonly used and Vitature-specific terms at the end of this user guide; bolded items are included in the glossary. This user guide is meant to help you get started; however, please don t hesitate to contact Vitature Support at or support@vitature.com if you can t find what you re looking for. System Requirements Vitature is a cloud-based application accessible from any computer with internet access. Page 3

4 Google Chrome is the recommended browser; pixels is the minimum screen resolution for optimal viewing. Logging In New Vitature users will receive an from a system administrator or Vitature account representative containing an activation link and information to create a username and password. Usernames must be a unique and valid company . Passwords are case sensitive and must be a minimum of eight characters. Forget your password? Click Forgot your password on the login page (Figure 2). If the link doesn t work, please contact your system administrator to receive a password-reset link. If your system administrator is unable to assist you, contact Vitature Support at or support@vitature.com. Figure 2: Login Page Page 4

5 General Settings Vitature has two user types, organization administrator and user (i.e., non-organization administrator). The organization administrator is someone designated by your company to manage user permissions. For both types of users, navigate to your settings by hovering over the person icon in the topright corner and clicking Settings (Figure 3). Figure 3: Accessing Settings Organization Administrator, Settings As an organization administrator, use the Support tab to access resources, including this user guide and FAQs. Use the Your Settings tab to update your display name, , title, department, or to change your password. Page 5

6 Use the Users tab to manage users. Click Create User to create a new user. In the edit modal, enter a valid company , the user s name, and select the type of user. Click Create and an account-activation link will be sent to the provided. a. Click Edit to manage the user s permissions. Click or unclick the Permissions checkboxes to control what the user can do (Figure 4). b. Click Send New Token to send users a new account-activation link should the link expire. c. Click Deactivate to deactivate users at any time; click Reactivate to reactivate users. Figure 4: Organization Administrator, Settings, Users Tab, Edit User Modal Use the Groups tab to create a group of users you can assign tasks to; add as many users to a group as needed. When you create a group, the group s name will appear in the Assigned To drop-down menu for you to select (Figure 5). Page 6

7 Figure 5: Example of Where Groups Appear Use the Company Shared Info tab to upload supplier qualification documents, including your supplier manual, supplier quality agreement, and qualification documents (Figure 6). Update your corporate contact information in the Organization Data Card. When you send a qualification request, suppliers will receive these qualification documents for review. They will then download them, physically sign them, and upload them to their submission. To update any of these documents, be sure to upload a new version (Figure 7). Page 7

8 Figure 6: Organization Administrator, Settings, "Company Shared Info" Tab, Step One to Uploading Qualification Documents Figure 7: Organization Administrator, Settings, "Company Shared Info" Tab, Step Two to Uploading Qualification Documents Use the Templates tab to choose from collaboration (qualification) request and supplier invitation templates (Figure 8). Edit templates as needed. If these templates don t fit your needs, click + Add Template to create your own. Page 8

9 Figure 8: Organization Administrator, Settings, " Templates" Tab Non-Organization Administrator, Settings As a non-organization administrator, use the Support tab to access resources, including this user guide and FAQs. Use the Your Settings tab to update your display name, , title, or department. Use the Company Shared Info tab to upload qualification documents. Use the System Info tab to view information related to the version of software in use, the schema version, and the database name. The Homepage To return to the homepage from anywhere in Vitature, click the Vitature logo in the top-left corner (Figure 9). The homepage displays: 1. The Metrics tab (Figure 9) a. View the statuses and quantities of materials, supplier materials, suppliers, and bulk formulas you are managing. Page 9

10 b. Click + Add New in the corresponding section to create a new Material Record or Bulk Formula. c. Click + Invite in the supplier s section to invite a supplier to collaborate on a qualification. d. Alerts clue you in to the statuses of materials, supplier materials, suppliers, and bulk formulas. 2. The Qualification Activity tab (Figure 10) a. Shows your supplier s company, material, and site qualification requests listed by supplier and material name. View the request date and the last activity associated with that request. 3. The Your Assignments tab a. Shows sections assigned to you for internal review. Figure 9: Homepage, Metrics Tab Page 10

11 Figure 10: Homepage, "Qualification Activity" Tab Click the bell icon in the top-right corner to access your notifications; if you have new notifications, a green dot will appear on top of the icon. Your notifications serve as a repository for all communication in Vitature (Figure 11); here, manage approvals, tasks, and upcoming expirations. Notifications of an overdue task or expiration will appear in red. Clicking a notification will take you to the task assigned to you or a group you are in. Notifications are automatically sent when tasks or notes are assigned. For example, if you need approval and sign-off on a material data sheet, assign the task to the appropriate group or user and they ll receive a notification to follow up. Whoever is assigned the task is the only one who can mark it as Complete. Click the question mark icon to access this user guide and release notes. New release notes are indicated by a blue dot over the question mark icon. Page 11

12 Figure 11: Notifications Search and Navigation The search box at the top of each page provides access to all your Material Records, Supplier Material Records, Supplier Records, and Site Records, as well as to the constantly evolving ingredient, science, and product research databases. When searching, after you click Enter or select a search result item, the search box will clear and be ready for your next search. There are a few ways to search and navigate Vitature: 1. To narrow search results to a specific record or research type use the All drop-down menu to the left of the search box (Figure 12) and select Materials, Supplier Materials, Suppliers, Sites, Ingredients, Products (currently in beta meaning it s not regularly updated), or Studies. For search results inclusive of all categories leave the selection as All. Page 12

13 Figure 12: The "All" Drop-Down Menu 2. To navigate directly to a record type or Index Page use the Go To drop-down menu to the right of the search box (Figure 13) and select Materials, Company, Customers, Supplier Materials, Suppliers, Bulk Formulas, Ingredient Research, Science Research, or Product Research, or Sites. Figure 13: The "Go To" Drop-Down Menu 3. Or, type a term into the search box for a drop-down menu of relevant options (Figure 14). The results listed are the top-five records in each category; click Browse All to see all results for a category. For example, if you type ginger into the search box the results will be sorted by: Materials: Material Records associated with ginger. Supplier Materials: Supplier Material Records associated with ginger. Ingredients: The Vitature Smart Ingredient Taxonomy associated with ginger. Suppliers: Supplier Records associated with ginger. Studies: Curated citations associated with ginger. (The Page 13

14 Vitature Science Database includes our Vitature Smart Ingredient Taxonomy, regulatory information, and over 300,000 citations for building claims and substantiation.) Figure 14: Searching for Ginger Using the Search Box Creating Material Records Vitature-provided Material Records were designed using the SIDI (Standardized Information on Dietary Ingredients) Protocol; they contain all the data and documents related to a material specification, including data sheet values such as nutrition composition, allergens, regulatory and compliance information, and studies to substantiate claims and use. Information stored in Material Records is downloadable for use outside Vitature. Create Material Records from the homepage, the material Index Page, or an ingredient research page. 1. To create a Material Record from the homepage, click + Add New (Figure 15) in the Materials section. Page 14

15 a. In the edit modal, click Browse Materials; if the material does not exist, click + Create New (Figure 16). Give the Material Record a name. If you enter an already existing name, a warning will appear stating, Name Exists. Here, create an iterative version of the material with the next sequential number in parenthesis [e.g., Material (#) ] or, click Cancel and enter a unique name. Select the type of ingredient from the drop-down menu to create an ingredient-specific record (botanical, non-botanical, or non-ingredient material). b. Or, click Copy from Existing Material to create a record containing prefilled testing methods, among other prefilled data. Use this copy option to reuse existing specifications and avoid starting from scratch. c. Click Create and the Material Record is ready to be worked on. Figure 15: Creating a Material Record from the Homepage Page 15

16 Figure 16: Creating a New Material Record 2. To create a Material Record from the material Index Page, click Materials in the Go To drop-down menu and once there, click + New Material (Figure 17). a. Follow the same steps outlined above. Note: To navigate to a specific page in all Index Pages, click into the pagination box at the bottom of the screen and type in the page number (Figure 18). This functionality applies to all results pages. Page 16

17 Figure 17: Creating a Material Record from the Material Index Page Figure 18: Material Index Page, Pagination Tool to Navigate to Specific Pages (Functionality Applies to All Results Pages) Page 17

18 3. To create a Material Record from an ingredient research page, use one of the search options previously discussed, to find, for example, Aloe vera (Figure 19). Figure 19: Navigate to the Ingredient Research Page for Aloe vera a. Once on the ingredient research page, hover over the Actions drop-down menu and click Create Material (Figure 20). Figure 20: Creating a New Material Record from an Ingredient Research Page b. Functionality is the same as for the previous two Material Record-creation methods with one exception: when you create a Material Record from an ingredient research Page 18

19 page, clicking Create Material gives you the option to associate the Smart Ingredient with the Material Record (Figure 21). Click Yes to connect this ingredient to the Material Record. Doing so automatically provides supplier material recommendations, if available. Figure 21: Associating a Smart Ingredient with a Material Record Navigating Material Records Once you click Create, the Material Record is ready to be worked on and you ll be taken to its Dashboard tab (Figure 22). Use the upper tabs to navigate between Metrics, Qualification Activity, and Your Assignments specific to this Material Record; use the left-hand menu to navigate between the tabs. Page 19

20 Figure 22: Material Record, "Dashboard" Tab Click Notes in the top menu bar of the Material Record (this functionality applies to all record types) to share notes with a team member (Figure 23). Share notes with multiple team members by holding the CTRL key when selecting multiple names. All users can add notes, regardless if they have status change permissions. We recommend filling in Material Records by first completing the Material Details Card in the Overview tab (Figure 23). Figure 23: Material Record, Overview Tab Page 20

21 To enter data, click the edit (pencil) icon; here, enter the material s details, including material name, part code, part description, material type, material group, material template (record) type, and ingredient usage. To assign the Card to another user for follow-up, select the user from the Assigned To dropdown menu at the top of the Card and add a due date. If the Card is assigned to you, click the Completed checkbox when you finish reviewing. Click Done to save and close the Card this functionality applies to all edit modals (Figure 24). Note: Use the Material Group field to enhance filters on the material Index Page. For example, if you enter organic into the Material Group field, you can filter Material Records to see only those that are organic. Figure 24: Material Record, "Overview" Tab, Material Details Card Building Material Specifications Material data sheets, located in the Data Sheet tab of Material Records, are composed of a Specification section; a Nutrition and Composition section; an Allergen and Certification section; a Regulatory and Compliance section; and a Factors and Miscellaneous section. 1. The Specification section (Figure 25) contains the following Cards: Page 21

22 Figure 25: Material Record, Data Sheet Tab, Specification Section a. Description: Stores data related to ingredient name, Latin binomial(s) [botanical ingredients only], synonym(s), product country of origin, CAS #, weight percent, molecular formula, and other ingredients. Add as many other ingredients as needed (useful when working on Material Records composed of multiple ingredients, such as herbal blends). b. Physical Characteristics: Stores data related to appearance, odor, and color/taste; specification (low/high tolerance levels); and test method. Add additional physical appearance attributes as needed. c. Identification: Stores data related to identification, specification (low/high tolerance levels), and test method. d. Assay: Stores data related to assay, specification (low/high tolerance levels), and test method. e. Properties (Figure 26): Stores data related to chemical property, specification (low/high tolerance levels), and test method. Page 22

23 Figure 26: Material Record, Data Sheet Tab, Specification Section, Properties Card To display the list of chemical properties, click in the Select Chemical Property box. If there s a chemical property we don t account for, click Add Property at the bottom of the list and type it in. Once you ve selected a chemical property, enter the tolerance levels and the test method used to verify your results. Add as many chemical properties, tolerance levels, units of measure, and test methods as needed. Note: The same functionality applies to all sections on the material specification tab. f. Heavy Metals: Stores data related to type of heavy metal, specification (low/high tolerance levels), and test method. g. Microbial: Stores data related to microbial contaminants, specification (low/high tolerance levels), and test method. h. Pesticides: Stores data related to pesticides, specification (low/high tolerance levels), and test method. i. Other Toxins: Stores data related to type of toxin, specification (low/high tolerance levels), and test method. j. Other: Add any additional specifications needed for this material. 2. The Nutrition and Composition section contains the following Cards: Page 23

24 a. Nutrition Amounts (Figure 27): Add nutritional component amounts here. Default values for all nutritional components are zero. Figure 27: Material Record, Data Sheet Tab, Nutrition and Composition Section, Nutrition Amounts Card b. Other Nutritional Composition (Figure 28): Add nutritional components we don t account for here. Values entered are used in Bulk Formula calculations to help ensure threshold limits are within range when combining materials. Page 24

25 Figure 28: Material Record, Data Sheet Tab, Nutrition and Composition Section, Other Nutritional Composition Card 3. The Allergen and Certifications section contains an Allergen Card, International Allergen Statements Card, and a Certifications Card. 4. The Regulatory and Compliance section contains a Legal Status Card, CA Prop 65 (OEHHA) Information Card, and a Regulatory Card. 5. The Factors and Miscellaneous section contains a Factors Card and a Miscellaneous Product Information Card. Here, enter information related to factors (as percentages) used in Bulk Formula calculations and analysis, and miscellaneous information related to the storage, transportation, and handling of the material. Note: The process for building supplier material specifications is the same as the one for building material specifications. The only difference is that if your workflow allows you to create material specifications from supplier material specifications, you can copy values from Supplier Material Records into Material Records. Page 25

26 Navigating Supplier Records To get to the supplier Index Page, which includes our expanding list of Supplier Records and their product catalogs (when available), click Suppliers in the Go To drop-down menu (Figure 29). Use filters in the left-hand menu to narrow your results. To see only Vitature-Registered suppliers, select the Vitature Registered filter; Vitature-Registered Supplier Records will display a Vitature-Registered badge (Figure 30). If you re looking for a specific supplier, type their name into the search box. If you can t find a supplier, click + Invite Supplier to invite them to register. Follow the prompts to send the supplier a registration request. Figure 29: Navigating the Supplier Index Page Figure 30: Supplier Record, Vitature-Registered Badge Page 26

27 Clicking a Supplier Record will take you to its Supplier Details tab (Figure 31), which is populated with information submitted by the supplier. Figure 31: Supplier Record, Supplier Details Tab a. Supplier Details tab: Displays general information about this supplier, including the company overview and company contact. b. Product Catalog tab: Displays the supplier s products, if available. c. Your Supplier Materials tab: Displays any Supplier Material Records, Site Records, and Material Records you have associated with this Supplier Record. Any information entered here is visible only to your company. d. Your Supplier Information tab: Here, manage your Supplier Record in addition to the data and documentation collected via the qualification process. e. Site Information tab: Here, manage all entities, including distributors, raw material manufacturers, growers, granulators, processors, and warehouses, that handled this supplier s materials prior to you purchasing them. Click + Add Site (Figure 32) to add a new site. Add site data (including general site information Page 27

28 and compliance data), as well as site documents. You can edit a site here, or at an associated supplier material all instances will be updated. Figure 32: Supplier Record, "Site Information" Tab, Adding a New Site The Supplier Company, Material, and Site Qualification Process To begin the supplier qualification process, you must first add the supplier to Your Suppliers List in the Supplier Details tab of a Supplier Record. To do this, hover over the Actions dropdown menu and click Add to My Suppliers (Figure 33). Once you add a supplier to Your Suppliers List, the Supplier Record s status will change to In Process. Page 28

29 Figure 33: Supplier Record, Supplier Details Tab, Adding a Supplier to Your Suppliers List After you add a supplier to Your Suppliers List, go to the Your Supplier Information tab, which has two sections: Supplier Record and Supplier Requests. 1. The Supplier Record section (Figure 34) is made up of two subsections, Overview and Document Checklist. a. The Overview subsection contains four Cards: State: Contains a report with the required fields and/or documents needed; access the report by clicking See Details in the Outstanding Information field (Figure 34). Company Tracking: Internal information related to this supplier, including supplier code, supplier qualification date, compliance notes, and supplier notes. Contact: Contact information for relevant supplier departments, including sales, quality, shipping, and product documentation. Additional Contacts: Enter additional contacts as needed. Page 29

30 Figure 34: Supplier Record, Your Supplier Information Tab, Supplier Record Section, Overview Subsection b. The Document Checklist subsection contains the standardized and configurable Document Checklist and associated documents. To assign a document to a field, from within the Assign Documents modal, grab it with your mouse and drag and drop it into the appropriate field (Figure 35). This drag-and-drop functionality applies to all places where you upload and assign documents. To remove a document from a field, first close the Assign Documents modal. Then, click the document and the red x next to it (Figure 36); this will remove the document from the field but won t delete the document. Page 30

31 Figure 35: Supplier Record, Your Supplier Information Tab, Supplier Record Section, Document Checklist Subsection, Uploading and Assigning Documents Figure 36: Supplier Record, Your Supplier Information Tab, Supplier Record Section, Document Checklist Subsection, Removing a Document from a Field 2. The Supplier Requests section (Figure 37) is where this supplier s site and company qualifications are managed (these qualifications are also manageable from the Supplier Page 31

32 Material Record in the Suppliers tab under the Supplier Requests section this section also includes the site and material qualifications). a. To send a site or company qualification request, first click Send Qualification Request (Figure 37). Figure 37: Supplier Record, Your Supplier Information Tab, Supplier Requests Section, Sending a Qualification Request Page 32

33 A pop-up will appear asking if you d like to include associated materials in this request. Select as many materials as needed (Figure 38). This allows you to include multiple material qualification requests within a single company qualification request. If you send a bundled request, the supplier only gets one , but sees every request when they log in to their account. Figure 38: Supplier Record, Your Supplier Information Tab, Supplier Requests Section, Sending a Company Qualification Request, Including Multiple Material Qualification Requests in a Single Company Qualification Request b. Select whether you d like to request All (this includes documents and contact information), Documents (this includes just documents select which ones you d like to request individually, or select All Missing Required Documents ), or Sections (this allows you to request just contact information, just documents, or both) [Figure 39]. The settings you choose apply to each and all of the materials and associated sites for this request. Page 33

34 Figure 39: Supplier Record, Your Supplier Information Tab, Supplier Requests Section, Sending a Company Qualification Request, Selecting Documents c. Click Next> Request Details. The Request Information section is prefilled with your information. Add your material requirements in the Message to Supplier field. If you are requesting a site qualification, and already have Site Records associated with this supplier, type the name of the sites into the Message to Supplier field so the supplier knows which sites you need documents and information for.. You also have the option to include Supplier Agreement Documents or a Vitature-generated material specification for the supplier to review. To select multiple users in the User Notification field, hold the CTRL key on your keyboard and click as many users as needed. d. Click Next> Send Request to send the supplier this request. Enter the supplier s address, select the appropriate template, or create your own (click Preview to review before sending), and click Finished> Send Request. e. Once a supplier submits a response to your request, the submission will appear in the Supplier Requests section with a Submitted status. Once you accept the submission, the status will change to Complete. Click View (Figure 41) to see the supplier s submission(s). Page 34

35 If you receive a supplier submission that includes a site qualification, click Check for Matches (Figure 40) to search for existing site records that may match the submitted site. If you see a site that matches, click Select and they will be automatically combined. Figure 40: Supplier Record, "Your Supplier Information" Tab, Supplier Requests Section, Site Qualification, Checking for Matching Sites Figure 41: Supplier Record, Your Supplier Information Tab, Supplier Requests Section, Viewing the Supplier s Submission(s) Page 35

36 f. When viewing a supplier submission, you have these options, both of which require you to re-enter your password: Accept Submission: Copies supplier-submitted information and documentation into your Supplier Record. o Supplier-submissions that are accepted are locked, but you can always request updated information by sending a new request. Do Not Use This Submission: Does not copy information or documentation into your official record. Send a new request to continue the qualification process. Use the drop-down menu to view all submitted versions. The supplier will also have a list of all submitted versions. You will have the option to review the submitted version and either accept or deny it. The Qualification Activity log on the Supplier Record will show company and site qualifications and their statuses. Any supplier materials that were included in the company qualification request will have an item listed in their respective Qualification Activity logs; the same goes for the Qualification Activity tab on the homepage. Creating and Navigating Supplier Material Records The data required to build Supplier Material Records is supplier-submitted via qualification and/or built by manufacturers based on supplier-submitted information and documents. Supplier Material Records allow you to associate and compare your Material Records with actual materials on the market for research, sourcing and procurement, and formulation. There can be a one-to-one correlation between a Material Record and a Supplier Material Record, or as you move through the qualification process, you may find you have multiple Supplier Material Records per Material Record to cover your bases for sourcing. Page 36

37 To create a Supplier Material Record, you must first create the Material Record you want to associate with it. Once you create the Material Record, look for supplier materials that meet your specifications. 1. To create a Supplier Material Record from within a Material Record, select the Suppliers tab (Figure 42). a. If you have associated this Material Record with Supplier Material Records, In Process and/or Approved Supplier Material Records will display in the Your Suppliers section. b. To create a Supplier Material Record, select the Find Another section. If suppliers have related products in Vitature, their products will appear here (products are populated using the Smart Ingredient feature). The View & Change button allows you to associate ingredients from the Vitature Smart Ingredient Taxonomy with Material Records, leveraging legal and regulatory information associated with each ingredient as well as science and product data. o Click + Create if you see a supplier product you want to use, which will create a Supplier Material Record based on the product. Page 37

38 Figure 42: Creating a Supplier Material Record from a Material Record o If you don t see a supplier material you want to use, but you have enough information on a product to get started, click Find Supplier. In the edit modal, click Select Supplier from List or, if the supplier is not on the list, click Invite Supplier and follow the prompts. Enter the product name or click Create New Product and Next. Click Save and you will be taken to the Supplier Material Record that is ready to be worked on. 2. To create a Supplier Material Record from within a Supplier Record, select the Product Catalog tab (Figure 43). a. If the supplier has products in Vitature they will appear here. b. Click + Add to associate a supplier s product with a Material Record. c. Select an existing Supplier Material Record, or click + Create New to create a new supplier material not listed in their product catalog. d. Click Create and you will be taken to the Supplier Material Record that is ready to be worked on. Page 38

39 Figure 43: Creating a Supplier Material Record from an Existing Supplier Record The Supplier Material Record contains the Supplier Material section and the Supplier Requests section. The subsections include Overview, Document Checklist, Manufacturing/Source, and Data Sheet. a. The Overview subsection is made up of these Cards: State: Contains a report generated according to outstanding requirements. To access this report, click the number in the Outstanding Information field. Supplier Product Details: Details related to the supplier material such as pricing, minimum order quantity, and compliance notes. Miscellaneous Product Information: Other product details, including package size, whether the packaging materials are recycled and recommended storage and transport. b. The Document Checklist subsection contains the Document Checklist and associated documents. Page 39

40 c. The Manufacturing/Source subsection contains information related to the manufacturing site, including data on corporate ownership (if different from contact), facility size, and facility history. Also stored here is site compliance information, including FDA registration number, audit history, and the Supplier CGMP Compliance Statement. d. The Data Sheet subsection matches the Data Sheet tab in the Material Record. To initiate the qualification process from the Supplier Material Record, select the Supplier Requests section, and follow the same steps as outlined in the previous chapter. Doing it this way, however, will not allow you to pick multiple materials when sending the qualification request. For that, you must initiate the qualification request from the Supplier Record. Record Statuses To change a record s status, click the status icon in the top menu (Figure 44). Click the Assign Approvers checkbox to add additional approvers and set a due date. All assigned approvers will receive a notification. If multiple approvers are assigned, the record s status won t change until all approvers' status and compliance risk selections are aligned. If you're the only approver needed, click the Just Me checkbox (Figure 44). Figure 44: Changing a Record's Status, Assigning Multiple Approvers or Selecting Only Yourself Page 40

41 Select a status from the Status drop-down menu (see end of this chapter for status definitions). If you enter a note when you change a record s status, the note will show in the status history log (click the status icon to access) [Figure 45]. Changing a status to or from Approved or Conditional Approval both require an electronic signature (Figure 45). Note: If you have status change permissions, you can bypass required fields and documents when changing the status to Approved or Conditional Approval. Figure 45: Changing a Record's Status Page 41

42 For Supplier Records and Supplier Material Records, users with status change permissions can use the Compliance Risk drop-down menu to assign a compliance risk level (Figure 46). For both types of records, the compliance risk level will appear on the State Card (Figure 47). Figure 46: Selecting a Compliance Risk Level for a Record Figure 47: Supplier Record, Your Supplier Information Tab, Overview Subsection, State Card, Viewing the Compliance Risk Level Status options: a. In Process : Default status meaning the record is currently in the qualification process. Page 42

43 b. Approved : Status meaning all required data and documents have been received and entered into the record and a member of your team has applied an electronic signature. Add a requalification date if desired to be notified when it s time to review. c. Do Not Use : Status meaning a record should not be used for sourcing. d. On Hold : Status meaning a record is in some phase of the qualification process and is not being actively considered for sourcing or procurement (e.g., because you re waiting on required documents from the supplier). e. Requalification : Status meaning a record was previously approved but is being reevaluated (e.g., because of document expiration). Add a requalification date and it will appear in a Supplier Record s Your Supplier Information tab, under the Overview subsection and in the State Card. f. Change Review : Status meaning a record was previously approved upon submission of new data or documents but has yet to be reviewed or approved. g. Conditional Approval : Status meaning a record doesn t have all the data and documents needed to start the procurement process; requires an electronic signature. Add a requalification date if desired to be notified when it s time to review. h. Archived : Status available for certain records that reduces clutter. To view archived records, use the Archived filter on Index Pages. Note: In Supplier Material Records, three status icons display the status in parenthesis after the supplier s name denotes that of the Supplier Record; the upper status denotes that of the associated Material Record; and the lower status denotes that of the Supplier Material Record (Figure 48). Page 43

44 Figure 48: Supplier Material Record, Three Statuses Displayed Archiving, Exporting, Digital Audit Trails, and Favoriting Archiving helps reduce clutter. Archived records aren t deleted, but won t appear in Index Pages, searches, reports, or on your homepage. Use filters to access archived records. 1. Archive records by hovering over the Actions drop-down menu and clicking Archive (Figure 49). The same functionality applies to these record types with one exception: if you archive a Material Record with associated Supplier Material Records, a modal (Figure 50) will appear informing you that, should you click Yes, any related Supplier Material Records will also be archived. Figure 49: Archiving a Record Page 44

45 Figure 50: Archiving a Material Record with Associated Supplier Material Records 2. View your archived records on Index Pages by clicking the Yes checkbox under the Archived filter. To unarchive a record, hover over the Actions drop-down menu and click Unarchive (Figure 51). As soon as you unarchive the record, it will reappear in your Index Pages, searches, reports, and on your homepage. If you unarchive a Material Record with associated Supplier Material Records, those Supplier Material Records will also be unarchived. Also accessible in the Actions drop-down menu are export options (Figure 51), including Export Material Spec (PDF or Excel), Export Documents (Zip), Export Full Data Sheet (PDF), Export to PDF with Supplier Materials (for Bulk Formulas), Export Test Data Sheet (PDF), Export Digital Audit Trail (Excel), and Export All Documents (for Supplier Material Records and Supplier Records: this exports a zipped bundle of current documents associated with each record, as well as a cover sheet summarizing what you have [and don t have] associated with the proper Document Checklist fields and a report of document expiration date if applicable). Page 45

46 Figure 51: Unarchiving a Record and Export Options Digital audit trails keep track of all user activity with date and time stamps to ensure accountability, traceability, and proof of action in the case of an audit; export an Excel digital audit trail for any record (Figure 52). Figure 52: Exporting a Digital Audit Trail Favoriting allows you to star your most-used Material Records, Supplier Material Records, and Bulk Formulas for quick access (Figure 53) and enables a filter on Index Pages (Figure 54). Page 46

47 Figure 53: Favoriting an Item Figure 54: Favorites Filter on the Material Index Page Comparing Your Data Sheet Values Against a Supplier s Comparing your data sheet values against those of a supplier allows you to determine whether you d like to continue pursuing the material for formulation. Comparing your values also allows you to leverage supplier-provided data to automatically build material specifications. To compare data sheet values: Page 47

48 1. Select the Supplier Material Record you d like to compare. Click the Data Sheet subsection, (Figure 55) which includes the following elements: Specification; Nutrition and Composition; Allergen and Certification; and Regulatory and Compliance. To compare values in the Identification Card, for example, click the edit icon. Figure 55: Supplier Material Record, "Suppliers Tab, Supplier Material Record Section, Data Sheet Subsection, Specification Element 2. In the edit modal, click Compare to Data Sheet (Figure 56). You ll see two columns (Figure 57): on the left are the supplier s data sheet values, and on the right are your values. Here, you have two options depending on where you are in the formulation process: a. If you ve entered requirements in your Material Record because you know what you need, the values will appear in the right-hand column for comparison. b. If you ve recieved a notification from a supplier regarding a new product, or you learn of a product already in Vitature and you want to build your material data sheet based on this information, instead of manually entering the data, click Copy to Data Sheet and all fields in your Material Record will automatically populate. Page 48

49 Figure 56: Supplier Material Record, "Suppliers Tab, Supplier Material Record Section, Data Sheet Subsection, Specification Element, Identification Card Edit Modal Figure 57: Supplier Material Record, "Suppliers Tab, Supplier Material Record Section, Data Sheet Subsection, Specification Element, Comparing Values on the Identification Card c. To assign a section to a team member for review, select the user or group from the Assigned To drop-down menu. You can also assign a due date and mark it as Completed if the section is assigned to you. Page 49

50 Vitature Smart Ingredient Taxonomy The absence of standardized naming conventions within the dietary supplement industry has made collaboration between suppliers, manufacturers, and regulatory departments a huge challenge. And while there are ingredient guides out there, such as the HOC (Herbs of Commerce) which is included in our taxonomy there are still vast numbers of synonyms and misspellings on supplement labels. Thus, the Vitature Smart Ingredient Taxonomy the culmination of two years of deep research into supplement labels and regulatory documents, with the goal of deciphering what ingredients supplement bottles contain and the regulatory status of those ingredients. The Vitature Smart Ingredient Taxonomy is compiled from various sources including HOC, supplement labels, MeSH taxonomy, regulatory lists (i.e., NDI Notifications and GRAS listings), and industry publications and curated by subject matter experts. To access the Vitature Smart Ingredient Taxonomy Index Page, use the Go To drop-down menu and click Ingredient Research (Figure 58). Page 50

51 Figure 58: Accessing the Vitature Smart Ingredient Taxonomy Index Page This will take you to the Vitature Smart Ingredient Taxonomy Index Page, which contains over 19,000 ingredients, including parts and prep methods as unique ingredients. Refine search results using filters. To find an ingredient s research page using the search box, type its name in (Figure 59) and select the ingredient result that best matches what you re researching. Page 51

52 Figure 59: Searching for Zinc s Research Page in the Vitature Smart Ingredient Taxonomy Once you select an ingredient, you ll be taken to the Overview tab (Figure 60) of the ingredient s research page. Use the left-hand menu to access all information related to the ingredient. 1. The Overview tab gives you a snapshot of information related to the ingredient, including its regulatory status and any warnings or advisories. Regulatory statuses that apply to the ingredient are green and checked off; whereas, if the ingredient has any warnings or advisories, this will be denoted with a red x. In the Overview tab are also names and sources and forms. a. Names: Other common names, botanical synonyms, HOC standard names, and brands associated with the ingredient. b. Sources and Forms: Sources of the ingredient, chemical compounds containing the ingredient, and what the ingredient is found in. Page 52

53 Figure 60: Vitature Smart Ingredient Taxonomy, Zinc s Research Page, Overview Tab 2. The Regulatory tab (Figure 61) includes HOC standard names, Pre-DSHEA, GRAS (Generally Recognized as Safe), and NDI (New Dietary Ingredient). All information is from relevant sources, including the CRN (Council for Responsible Nutrition), NNFA (National Nutritional Foods Association), AHPA (American Herbal Products Association), and the US FDA (US Food and Drug Administration). Related matches will appear in the right-hand column. Figure 61: Vitature Smart Ingredient Taxonomy, Zinc s Research Page, Regulatory Tab 3. The Warnings and Advisories tab tells you if the ingredient is flagged for Prop 65, FDA Safety Alerts and Advisories, Adulteration, or on the USADA High-Risk List. 4. The Studied Topics tab (Figure 62) displays all citations associated with the ingredient. Filter studies based on study type (human, animal, or in vitro); study design (comparative Page 53

54 study, prospective study, etc.); journal ranking (top tier, mid-tier, or bottom tier); relevance level (top tier, mid-tier, or bottom tier); curation status (curated or un-curated); or publication year range. Sort studies based on a list of relevant health topics. Figure 62: Vitature Smart Ingredient Taxonomy, Zinc s Research Page, Studied Topics Tab 5. The Side Effects and Interactions tab (Figure 63) displays known supplement or drug interactions with the ingredient, as well as side effects. Figure 63: Vitature Smart Ingredient Taxonomy, Zinc s Research Page, Side Effects and Interactions Tab 6. The Product Categories tab (Figure 64) gives you market insight into how many, and what kind of, products the ingredient is used in. Filter products based on brands; certifications (fair-trade certified, kosher certified, etc.); free-of (gluten-free, GMO-free, etc.); other attributes (food-based, raw, etc.); or dosage forms (gel, gummy, etc.). Page 54

55 Figure 64: Vitature Smart Ingredient Taxonomy, Zinc s Research Page, Product Categories Tab 7. The Suppliers tab (Figure 65) displays suppliers offering the ingredient. Figure 65: Vitature Smart Ingredient Taxonomy, Zinc s Research Page, Suppliers Tab 8. The History tab shows the ingredient s research history. Sort results by date, type, or user. If there s already a Material Record associated with the ingredient, navigate directly to the Material Record by selecting the ingredient. Vitature Science Database Use the constantly updated, comprehensive Vitature Science Database, including over 300,000 citations, for researching ingredients and building label claims and substantiation. To access the Vitature Science Database Index Page, hover over the Go To drop-down menu (Figure 66) and select Science Research. Page 55

56 Figure 66: Accessing the Vitature Science Database Index Page Drill down to relevant studies using filters (Figure 67). Filter studies by proprietary and published studies, ingredients, health topics, study types, study designs, journal rankings, relevance levels, reviewed studies, or publication year ranges. Page 56

57 Figure 67: Vitature Science Database Index Page, Filters a. For example, if you re searching for studies related to Aloe vera, select the Ingredient filter and type in, and click, Aloe (Aloe spp.) [Figure 68]. Figure 68: Searching for Studies Related to Aloe in the Vitature Science Database Page 57

58 b. To narrow results further, apply additional filters (Figure 69). For example, select the Health Topics filter, click health topics you re interested in, and click Done. Figure 69: Filtering Aloe-Related Studies by Health Topic c. To narrow results even further, select the Study Type filter, click Human, for example, and click Done (Figure 70). Figure 70: Filtering Aloe-Related Studies by Study Type Page 58

59 Select a study to access the study s overview, including the citation and abstract, as well as other information relevant to the study (Figure 71). Download the study to Excel or PDF by hovering over the Actions drop-down menu. If the study s full text is available, a direct link is accessible in the same drop-down menu. Please note some PubMed studies sit behind a paywall. Figure 71: Vitature Science Database, Study Overview, Download Options Uploading Studies and Associating Studies with Records Upload and associate studies from the Vitature Science Database, including proprietary studies, with Material Records or Supplier Material Records. Uploaded studies are only available to your company. 1. To upload a study, click Upload Study at the top of the Vitature Science Database Index Page (Figure 72). All rights reserved. Healthnotes, the Healthnotes logos, and the Healthnotes product and service names mentioned herein are registered trademarks or trademarks Page 59

60 Figure 72: Uploading a Study to the Vitature Science Database 2. In the study editor modal, enter the study s details and click Upload Document (Figure 73). Another modal will appear asking you to choose the files you want to upload. Figure 73: Vitature Science Database, Entering a Study s Details into the Study Editor Modal Material Records have the Vitature Science Database embedded into them, enabling you to do research and associate science with records to substantiate label claims without deviating from your workflow. All rights reserved. Healthnotes, the Healthnotes logos, and the Healthnotes product and service names mentioned herein are registered trademarks or trademarks Page 60

61 To associate a study with a Material Record: 1. From a Material Record, select the Science tab (Figure 74). Any claims you have associated with this material will show here. Click View/Edit to view and edit claims. Here, you ll also see any Smart Ingredients associated with this material. 2. To add a claim, click + Add Claim. In the modal, enter your label claim statement and notes, upload a study, find a study, or add Smart Ingredients (Figure 75). Figure 74: Material Record, Science Tab, Claims Section, Adding a Claim Figure 75: Material Record, Science Tab, Claims Section, Add/Edit Claim Modal, Uploading a Study and Adding Smart Ingredients All rights reserved. Healthnotes, the Healthnotes logos, and the Healthnotes product and service names mentioned herein are registered trademarks or trademarks Page 61

62 Vitature Product Research Database The Vitature Product Research Database, currently in beta, helps you find your competitive edge. Use it to conduct preliminary market research when initiating product ideation. 1. To access the Vitature Product Research Database Index Page hover over the Go To drop-down menu and select Product Research (Figure 76). Figure 76: Accessing the Vitature Product Research Database Index Page 2. This will take you to the Vitature Product Research Database Index Page, which includes over 58,000 products. Use filters to narrow your search. Sort results using the Sort By drop-down menu (Figure 77). All rights reserved. Healthnotes, the Healthnotes logos, and the Healthnotes product and service names mentioned herein are registered trademarks or trademarks Page 62

63 Figure 77: Vitature Product Research Database, Filters and Sort By Drop-Down Menu Bulk Formulas Bulk Formulas provide an analysis of risk factors and claim disclosures for your formulas and are built around your Material Records. To create a Bulk Formula from the homepage, click + Add New in the Bulk Formulas section (Figure 78). You can also create bulk formulas by clicking Bulk Formulas in the Go To dropdown menu. This takes you to the Bulk Formula Index Page. All rights reserved. Healthnotes, the Healthnotes logos, and the Healthnotes product and service names mentioned herein are registered trademarks or trademarks Page 63

64 Figure 78: Creating a New Bulk Formula from the Homepage Click Browse Formulas and, if the Bulk Formula doesn t exist, click + Create New. Give the Bulk Formula and name and click Create. This will take you to the Overview section of the Bulk Formula (Figure 79). Figure 79: Bulk Formula, Overview Section All rights reserved. Healthnotes, the Healthnotes logos, and the Healthnotes product and service names mentioned herein are registered trademarks or trademarks Page 64

65 Bulk Formulas contain the following sections: Overview, Formula, Documents, and Reports. 1. The Overview section contains the following Cards: Description, Facts Panel, and Certifications. a. Description: name, code, description, customer name, customer code, form, and count. b. Facts Panel: serving size, servings per container, suggested use, and warnings. c. Certifications: certifications and free-of (such as soy-free). 2. The Formula section contains the list of Material Records, including Supplier Material Records, associated with the Bulk Formula. 3. The Documents section contains any related documents, including studies, you have associated with the Bulk Formula. Upload new documents here. 4. The Reports section contains roll-up reports for the Bulk Formula based on regulatory status, toxins, nutrition and composition, allergens, and certifications, and offers insight into the materials you ve selected for formulation. Click each subsection in the Reports section to access reports pertaining to your Bulk Formula. Bulk Formula Calculations The below elements drive Bulk Formula calculations. 1. Material: The ingredients listed on the label. 2. Physical (Label) Amount: The amount of the ingredients listed on the label. 3. Factor: The amount of the ingredient needed to meet the label claim of the delivered nutrient. For example, calcium carbonate is 40% calcium. If you want to claim 1,000 mg of calcium on your label, you must include 2,500 mg of the ingredient in your formulation. 4. Overage: The amount of ingredient over the label amount to account for stability and potency over the product s shelf-life. All rights reserved. Healthnotes, the Healthnotes logos, and the Healthnotes product and service names mentioned herein are registered trademarks or trademarks Page 65

66 Submitting Questions and Feedback Use the Usersnap feedback tool (Figure 80), located at the bottom-right corner of each page, to contact Vitature Support. Figure 80: Usersnap Feedback Tool Usersnap records your request along with a screenshot and notifies Vitature Support (Figure 81). Figure 81: Usersnap Feedback Tool We ll respond to your request as quickly as possible. If you have an immediate question or concern, please contact your system administrator or Vitature Support at or support@vitature.com. All rights reserved. Healthnotes, the Healthnotes logos, and the Healthnotes product and service names mentioned herein are registered trademarks or trademarks Page 66

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