Company Name: Address: Project Name: Server Name: Server Location: IQ Prepared By: Name / Title / Representing

Transcription

1 Company Name: Address: Project Name: Server Name: Server Location: IQ Prepared By: Name / Title / Representing Signature / Date Document Release date 10 th June 2013 Page 1 of 18

2 Contents 1. Objective Procedure Prerequisites Execution Protocol Completion Acceptance Criteria Document Control Pre-IQ Approval from Customer IQ Roles and Responsibilities Execution Signature Verification PharmaReady UpGRADE PRE-REQUISITE INSTALLTION PharmaReady UpGRADE Microsoft SHAREPOINT UPGRADE Document Release date 10 th June 2013 Page 2 of 18

3 1. OBJECTIVE This protocol outlines the requirements for the Upgrade to Version 5.1 from version 4.3 of the PharmaReady software on the PharmaReady Server platform(s). The IQ upgrade protocol is developed by the manufacturer and defines the steps to install all necessary software components and application modules. Successful completion of this IQ protocol provides assurance that the software is installed in accordance with the manufacturer s recommendations, and establishes a baseline document for use in change control and to aid in troubleshooting. This protocol is a part of the overall validation effort for PharmaReady Version PROCEDURE 2.1. Prerequisites 2.2. Execution All hardware, software, and infrastructure requirements must be completed. Pre Upgrade checklist provided to customer System Admin Supplemental Details form provided to customer Print the Installation Qualification document. Execute the Installation Qualification on the PharmaReady server. Follow the instructions for each table in this document. Document all results, reviews, verifications, and screen shots at the time they are executed. All screen prints must be created in a single MS Word document Screen Capture Document. The Screen Capture Document will be labeled with the following information: o Header contains: Project Name: Version#: Test Case Name: IQ-Server o Each Picture in Screen Capture Document Test Case Step # above or below picture o Each Page of Screen Capture Document Testers Initials Testing Date Assemble Screen Capture Document to the back of the applicable test case. Execute mini OQ. Tester The Tester writes their name in the Performed by field at the beginning of each section. Document Release date 10 th June 2013 Page 3 of 18

4 The Tester enters Pass or Fail in the Observed Results As Expected column. If the expected results are not as expected write a deviation report. The tester should write a deviation report when: o The protocol step is inaccurate. o The data is entered incorrectly. o A screen shot was not taken for a required step. The Tester enters their initials and the date in the Tested & Verified By/Date column to indicate an acceptable result. The Tester will label each screen print with the section identified, corresponding to results. Verifier The Verifier verifies the execution of the IQ and ensures all screen captures reflect the correct data. The Verifier reviews the documentation to ensure all sections are completed The Verifier writes their name in the Verified by field at the beginning of each section. Reviewer The Customer QA/Regulatory representative will review the documentation to ensure all sections are completed and writes their name in the Reviewed by field at the end of each section. The Reviewer reviews the documentation to ensure all sections are completed A shaded area in a table does not require an entry Protocol Completion After completing the execution of the IQ, TAKE Solutions will retain a photocopy of the completed IQ document and all supporting documentation for support purposes. TAKE Solutions will provide original executed IQ documents to the customer. After completing the execution of the Installation Qualification, submit the completed protocol with supporting data and all deviation reports to the Quality Assurance Manager. Document Release date 10 th June 2013 Page 4 of 18

5 2.4. Acceptance Criteria 3. DOCUMENT CONTROL Criteria for accepting the Installation Qualification phase as being complete are: o The IQ document has been executed and all screen captures are printed, labeled, initialed, and dated. o Any deviations encountered have a corresponding deviation report that is corrected or resolved. o The IQ document has been verified by a witness. o The IQ document has been reviewed by quality assurance or designee. o The IQ document has been approved by the customer. Approver The Customer QA/Regulatory/Project Manager will approve the documentation to ensure all sections are completed and write their name in the Post-Execution Approval table at the end of the protocol. Authored by: Reviewed by: Approved by: Ashok John, Implementation & Support Engineer Date 10 th June 2013 Baskar Balaji Senior Implementation & Support Engineer Date 10 th June 2013 Vijay Srinivasan, Sr. Implementation & Support Manager Date 10 th June 2013 REVISION HISTORY Version Date Author Remarks th June2013 Ashok John Initial Version. Document Release date 10 th June 2013 Page 5 of 18

6 4. PRE-IQ APPROVAL FROM CUSTOMER The signatures below indicate approval of this IQ for execution by authorized customer staff. Name/Title Signature Date 5. IQ ROLES AND RESPONSIBILITIES Indicate each person s responsibility in the installation qualification protocol process. Name Title Role (Tester, Verifier, Reviewer, Approver) Document Release date 10 th June 2013 Page 6 of 18

7 6. EXECUTION SIGNATURE VERIFICATION Instructions: All personnel assigned to execute, verify, or review this protocol, attached exceptions and/or supporting documentation must sign and initial in the space provided below. This is for signature and initial verification. Printed Name Signature and Initials Affiliation Document Release date 10 th June 2013 Page 7 of 18

8 7. PHARMAREADY UPGRADE PRE-REQUISITE INSTALLTION Instructions: These steps have to be followed in PharmaReady DATABASE Server. Performed by: Verified by: Date: Date: Operation Tested & Verified By/ Date 7.1. Ensure.Net Framework 4.0 is installed in Database Server Install Visual Basic Power Pack Setup 2.0 available in the PharmaReady Migration distribution media Ensure the Regional Settings (Date and Time Format and System Locale) are set to English (United States). Open Control Panel Regional and Language Options. On the Formats Tab, set Data and Time format to English (United States) Go to Administrative Tab and select English (United States) for System Locale Restore and Upgrade PharmaReady 4.3 to PharmaReady Take a backup the PharmaReady 4.3 Database. Move it to PharmaReady 5.x Database Server and Restore it with name as PR43 Execute the PR_43_Patch8.SQL script in PR43 Database to upgrade it to PharmaReady version of database. Document Release date 10 th June 2013 Page 8 of 18

9 Operation Tested & Verified By/ Date 7.5. Delete the PharmaReady 5.X Database if you have done OQ on top of it. Restore the database backup (FreshBuild6-Mar bak) available in the Upgrade distribution package with the name as PharmaReady Assign pradmin SQL user as database Owner to PR43 and PharmaReady Database. Open SQL Management studio. From the list of available database, Right click on PR43 and Choose Properties. In the Database Properties dialog box, move to Files Tab. In the owner text box, type pradmin (This is SQL user not AD account.) Click OK. Follow the same process for PharmaReady database Ensure SharePoint WSS 3.0 is upgraded with Service Pack 2 before taking backup from PharmaReady 4.3 Server. Execute the installer named as wssv3sp2-kb x86- fullfile-en-us Open SQL Management studio. Take the Backup of WSS_Content and move it to PharmaReady 5.0 Server. Restore it with name as WSS_Content_Live Once restore is complete, Right click on WSS_Content_Live and Choose Properties. In the Database Properties dialog box, move to Files Tab. In the owner text box, type TAKESOLUTIONS\PharmarReadyServiceAccount (This is the AS account not SQL user.) Document Release date 10 th June 2013 Page 9 of 18

10 Operation Tested & Verified By/ Date Click OK Clean the ectddocuments, ectdcompile and SPLPublish folders which might have the OQ data Move ectdcompile folder from the PharmaReady 4.3 Server to PharmaReady 5.0 Servers. 2.0 Move SPL labels from SPLPublish folder in PharmaReady 4.3 server to SPLPublish folder in PharmaReady 5.X server. 2.1 Move the images files from uploads folder in PharmaReady 4.3 server to uploads folder in PharmaReady 5.X server to migrate the SPL images from 4.3 versions to 5.X version. Location of uploads folder in PharmaReady 4.3 server: C:\Program Files\TAKE Solutions\PharmaReady\web\PR\uploads Location of uploads folder in PharmaReady 5.X server: For 32 bit: C:\Program Files\TAKE Solutions\PharmaReady\web\PR\uploads For 64 bit: C:\Program Files (x86)\take Solutions\PharmaReady\web\PR\uploads Document Release date 10 th June 2013 Page 10 of 18

11 Comments: Reviewed By: Date: Document Release date 10 th June 2013 Page 11 of 18

12 8. PHARMAREADY UPGRADE Instructions: These steps have to be followed in PharmaReady DATABASE Server. Performed by: Verified by: Date: Date: Operation Tested & Verified By/ Date 8.1. Execute PRMigrationUtility.exe file which will be available in Migration Package folder to upgrade the database to PharmaReady 5.X compatible and move all the records from PR43 to PharmaReady database. Click Next on Welcome and Instructions screens, Enter the login name of AD user account created for PharmaReady (Without Domain name), Enter the Password, Select the Database Server Choose PR43 as Source Database and PharmaReady as Destination database, On the ectd Document Migration Details screen, UNCHECK the ectd Documents to be Migrated check box and leave the ectd Compile and ectd Documents folder empty, Click Next and Finish. Wait till the installer show the migration is complete message. This may take several minutes depends on the volume of data in PR43 database Execute PRMigrationUtility.exe file which will be available in ectddocumentmigration folder to make compile output compatible for PharmaReady 5.X application to use as source documents. Document Release date 10 th June 2013 Page 12 of 18

13 Operation Tested & Verified By/ Date Click Next on Welcome and Instructions screens, Enter the login name of AD user account created for PharmaReady (Without Domain name), Enter the Password, Select the Database Server Choose PR43 as Source Database and PharmaReady as Destination database, On the ectd Document Migration Details screen, CHECK the ectd Documents to be Migrated check box, Enter the ectd Compile and ectd Documents folder location, (Ensure this is a valid location by typing the same location in windows explorer) Click Next and Finish. Wait till the installer show the migration is complete message. Copy the details displayed in Installer status screen to submit as a proof for list of submission moved to version 5.X 8.3. Execute PR_50_Patch14_Migration.SQL Script in PharmaReady database Run SPLExcelDataIntegration.exe found in the folder SPL- Active Ingredient Update Execute this query in PharmaReady 5.X database. update pr_spl_usagentimporter set RecordStatus= Run Migration.exe found in the folder SPL Importer Utility. Document Release date 10 th June 2013 Page 13 of 18

14 8.7. Install PharmaReady Patch. (Ensure PR_50_Patch14.SQL is executed and reports are updated) 8.8. Configurations to be changed in PharmaReady application and database. Update the License keys manually, Open pr_sys_systemsettings table and ensure the theme columnhas value = New (If you see a didfferent value then change it to New) Open PharmaReady application in web browser, go to System settings page. Change the AD user account details (Domain, User name, Password) address and alias (if required) Change the PRDocuments location. This might be pointing to OLDER Server, Likewise, change ectdcompile and SPLPublish locations. Document Release date 10 th June 2013 Page 14 of 18

15 Comments: Reviewed By: Date: Document Release date 10 th June 2013 Page 15 of 18

16 9. MICROSOFT SHAREPOINT UPGRADE Instructions: These steps are applicable only if 64 bit installation i.e., only if Microsoft SharePoint is installed. Performed by: Verified by: Operation Date: Date: Tested & Verified By/ Date 9.1. Open the SharePoint management shell as ADMINISTRATOR and run the command in the WSS 4.0 Dismount-SPContentDatabase WSS_Content This is to Detach the content database of PRDocument site in WSS 4.0 (PR 5.x) 9.2. Type Y and press enter key to continue detaching Type the command below to Verify the restored content database of WSS3.0 is valid for PRDocument site in WSS 4.0 Test-SPContentDatabase -name WSS_Content_Live webapplication Type the command below to attach the restored content database of wss3.0 into PRDocument site in wss4.0 Mount-SPContentDatabase WSS_Content_Live DatabaseServer SERVERNAME - WebApplication On complete, Open the site and check whether you can see all the documents and folder whichever was there in WSS 3.0 environment. Document Release date 10 th June 2013 Page 16 of 18

17 Comments: Reviewed By: Date: 10. POST-EXECUTION APPROVAL The signatures below indicate approval of this executed protocol by TAKE Solutions. Name Signature Company Date Document Release date 10 th June 2013 Page 17 of 18

18 11. PROTOCOL DEVIATION REPORT Print as many copies of this page as necessary. Describe each Deviation on a separate page. Number: Date: Protocol Section: Step #: Deviation: Initiator: Date: Corrective Action: Resolved By: Reviewed By: Date: Date: Document Release date 10 th June 2013 Page 18 of 18