Quick Notes Table of Contents

Transcription

1 Quick Notes Table of Contents How to add the Image in SPL Editor?... 2 How to add the alternative text for an image?... 6 How to Add or Delete Bookmark?... 7 Add Bookmark... 7 Delete Bookmark... 9 How to Add or Remove Hyperlinks? Add Hyperlinks Remove Hyperlinks How to Add or Remove or Edit the Footnote? Add Footnote Remove Footnote Edit Footnote How to Add Recent Major Changes? How to add Table Header, Table Footer and Table Caption? Table Header Table Footer Table Caption How to create a Link to Table? How to add application type prefix based on the marketing category? Validation errors in PharmaReady... 22

2 How to add the Image in SPL Editor? 1. Go to section where you wanted to add an image, Click the Image manager icon. The Image manager window will get open as below.

3 2. Click on Upload icon and then Select to upload the image from your PC. Make sure your image file has an extension jpg (lower case) and less than 1 MB of size, not in JPEG (format differs) or JPG (upper case) Select Overwrite if file exists? Checkbox and click Upload.

4 3. In Image manager window, Go to Properties tab and provide Alternative text and click Insert at the bottom of the page.

5 4. The Image will be added, then Click on Save button to save the chnages.

6 How to add the alternative text for an image? 1. Right click on the image Choose properties. 2. Provide the Alternative text and click OK. 3. Save the Section.

7 How to Add or Delete Bookmark? Add Bookmark 1. Select the desired folder in the Narrative Content section. 2. Right click and select the edit option. 3. Select the text you want to make a bookmark, then click the Add Bookmark ( ) button, which displays the SPL Book Mark window.

8 4. Enter a letter value in the Bookmark Name field:

9 5. Click the Add button in the SPL Book Mark Window. The bookmark will now appear as a destination option when creating links. In the RAD Editor, the bookmarked text is highlighted with a pink color appears just before the text it references, as shown in the sample below: Delete Bookmark 1. In edit mode in any section, click the Delete Bookmark ( ) button. 2. Click on the radio button to select the bookmark that you wish to delete and then click the Delete button.

10 How to Add or Remove Hyperlinks? Add Hyperlinks Links in a label are literally hyperlinks from a piece of text to either a section or a bookmark. Before a section can become a destination for a hyperlink, it must include saved content. 1. Select the text you want to make a link, then click the Add Link ( ) button, which displays the Add Hyperlink window as shown in the sample below: 2. Select a Section or Manually created bookmark, then click the Add Link button.

11 3. Click the Save button in the SPL Label Manager Page. In the RAD editor links appear created, as shown in the below sample: Remove Hyperlinks Right-click on the Hyperlink and choose Remove Hyperlink.

12 How to Add or Remove or Edit the Footnote? Add Footnote You can add footnotes that appear at the bottom of any table. Footnote text can be manually typed or pasted from another source into the text box on the Footnote page. 1. While in edit mode in any section, place your cursor where you want the footnote created, then click the Add Footnote ( ) button. 2. This displays the Foot Note window. 3. Enter the Footnote text as shown in the sample below: 4. Click the Save button.

13 5. In the RAD Editor, a footnote is indicated by a Strong red line just after the text it references, as shown in the below sample: Remove Footnote In the event you need to remove the contents of a footnote, click the Remove Footnote ( ) button. This displays the Delete Footnote window. Select the footnote you wanted to remove and click the delete button.

14 Edit Footnote 1. While in edit mode in any section, click on Add/Edit Footnote ( ) button. This displays the Footnote window with all the Foot notes created, Select the one you want to edit as shown below.

15 2. Edit the content and hit Save

16 How to Add Recent Major Changes? Recent major changes are indicated with a solid black vertical bar in the label PREVIEW on left-hand side margin. While in edit mode, highlight the content and click on the Add Recent Major Changes ( ) button. In the RAD Editor, recent major changes will appear with a Red color box as shown below: You can preview the section / label to see the Vertical bar on left hand side of highlighted content.

17 How to add Table Header, Table Footer and Table Caption? Table Header 1. In Edit mode, once you have pasted the Table from Word / XML 2. Select the entire row which is to be the TABLE HEADER and hit table header icon. The Table header will be created as shown below.

18 Table Footer 1. Select any row fully inside the table and click table Footer icon. A row will be created at the bottom of the table with text for table footer text type here! as shown below. 2. Copy and paste your TABLE FOOTER content along with Sample text that appears automatically and then you can remove the sample text for table footer text type here! 3. Save the section.

19 Table Caption 1. Place the cursor anywhere inside the table and click Table Caption icon. 2. Copy and paste your TABLE CAPTION content along with Sample text that appears automatically and then you can remove the sample text for table footer text type here! 3. Save the section.

20 How to create a Link to Table? 1. Select any content within table and click on Add Table Link icon. The SPL Book Mark dialog box will display as below. 2. Enter any name as Bookmark Name for easy reference and click on Add. 3. Highlight the text from where you want to make a link to table, and then click on Add Link ( ) button, which displays a dialog box as below:

21 4. Select the Bookmark and click Add. (In this case, the bookmark what we created for the table is Table1 ) 5. Link will be created for the table. Text with Table hyperlink will appear Blue color as shown below. How to add application type prefix based on the marketing category? 1. Go to product data element, select the marketing information of your drug product strength 2. If the marketing category is selected and application number is provided means, you have to provide the respective prefix of that marketing category in Application type prefix field.

22 Validation errors in PharmaReady 1. (809, 42): Element {urn: hl7-org:v3} content is unexpected according to content model of parent element {urn:hl7-org:v3} list. (913, 11): Validation failed. (Or) 2. (232, 366): Element {urn:hl7-org:v3}br is unexpected according to content model of parent element {urn:hl7-org:v3}sup.

23 (232, 372): The element {urn:hl7-org:v3}br is used but not declared in the DTD/Schema. (474,11): Validate failed. (Or) 3. Error in Creating XML files: SPL Narrative content Compile error: <, hexadecimal value 0x3C, is an invalid attribute character. Line 1, position 410.

24 Reason: This error may occur due to formatting issue in contents added in the SPL. Resolution: 1. Validate all individual sections one by one in that SPL. 2. By validating one by one, we can identify error facing section. 3. Edit that section, cut the content from that section and paste it in notepad. 4. Once aging copy it from notepad and paste it in that section. So it will clear the formatting issue. 5. Now you can validate the SPL without any issue. 4. The Network name cannot be found Reason: SPL Publish folder path is not correct in SPL system settings. Resolutions: 1. Login into pharmaready and navigate to SPL module. 2. In the SPL home page, under main menu item you can see the system setting option. 3. Click the system setting option and provide the SPL Publish path correctly.

25 5. (110,57): Union doesn t support this value. The attribute value with value 1 of 2 failed to parse. (200,57}: Union doesn t support this value. The attribute value with value 2 of 2 failed to parse. {673,11}; Validate failed. Reason: This error will occur if you have given the wrong values (like 1 of 2 or 2 of 2) in the Part in Product column of Multicomponent drug Product.

26 Resolutions: In the Product Data Info page, Select Component name, you will find a text box as Part in Product, Ensure you enter a whole number (e.g. correct format: 1, Wrong format: 1 of 2) and click on Save button. Marketing Category vs. Application Number The following are validation procedures relating marketing category to application numbers: 1. If the Marketing category is C73583 (ANADA), C73584 (ANDA), C73585 (BLA), C73588 (conditional NADA), C73593 (NADA), C73594 (NDA), C73605 (NDA authorized generic), C75302 (IND), C80438 (Exempt device), C80440 (Humanitarian Device Exemption), C80441 (Premarket Application), or C80442 (Premarket Notification) or C92556 (Legally Marketed Unapproved New Animal Drugs for Minor Species), then there should be six digit application number(fda application tracking system). 2. If the Marketing category is C73603 (OTC monograph final) or C73604 (OTC monograph not final), then there should be Code of Federal Regulations. 3. If the Marketing category is C73583 (ANADA), then the Application type prefix is ANADA. 4. If the Marketing category is C73584 (ANDA), then the Application type prefix is ANDA or BA. 5. If the Marketing category is C73585 (BLA), then the Application type prefix is BLA. 6. If the Marketing category is C73593 (NADA) or C73588 (Conditional NADA), then the Application type prefix is NADA. 7. If the Marketing category is C73594 (NDA) or C73605 NDA authorized generic), then the Application type prefix is NDA or BN.

27 8. If the Marketing category is C75302 (IND), then the Application type prefix is IND. 9. If the Marketing category is C92556 (Legally Marketed Unapproved New Animal Drugs for Minor Species), then the Application type prefix is MIF. 10. If the Marketing category is C80440 (Humanitarian Device Exemption), then the Application type prefix is H. 11. If the Marketing category is C80441 (Premarket Application), then the Application type prefix is P or BP. 12. If the Marketing category is C80442 (Premarket Notification), then the Application type prefix is K or BK. 13. If the marketing category is C95600 (Approved drug product manufactured exclusively for private label distributor), then the Application type prefix is NDA, ANDA, or BLA. Link from FDA: f