Document Version th November Company Name: Address: Project Name: Server Name: Server Location:

Transcription

1 Company Name: Address: Project Name: Server Name: Server Location: IQ Prepared By: Name / Title / Representing Signature / Date Document Release date 18 th November 2013 Page 1 of 20

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 18 th November 2013 Page 2 of 20

3 1. OBJECTIVE This protocol outlines the requirements for the Upgrade to Version 5.x from version 4.0 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 5.x. 2. 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 18 th November 2013 Page 3 of 20

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 18 th November 2013 Page 4 of 20

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, Senior Implementation & Support Engineer Date 14 th June 2014 Rajesh Prabu S.S Implementation & Support Engineer Date 14 th June 2014 Vijay Srinivasan, Sr. Implementation & Support Manager Date 14 th June 2014 REVISION HISTORY Version Date Author Remarks th June2014 Ashok John Initial Version. Document Release date 18 th November 2013 Page 5 of 20

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 18 th November 2013 Page 6 of 20

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 18 th November 2013 Page 7 of 20

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 4.0 database to PharmaReady Take a backup the PharmaReady 4.0 Database. Move it to PharmaReady 5.x Database Server and Restore it with name as PR40. Execute the following script in PR40 Database to upgrade it to PharmaReady version of database. o PR40 to PR43 Script (Step 1).sql Document Release date 18 th November 2013 Page 8 of 20

9 Operation Tested & Verified By/ Date o o o DROP ectd and SPL Tables (Step 2).sql ectd_spl_create TABLE SCRIPT (Step 3).sql PR_43_Patch8 (Step 4).sql 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. Document Release date 18 th November 2013 Page 9 of 20

10 Comments: Reviewed By: Date: Document Release date 18 th November 2013 Page 10 of 20

11 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 PR40 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 PR40 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 PR_50_Patch14_Migration.SQL Script in PharmaReady database. Document Release date 18 th November 2013 Page 11 of 20

12 8.3. Install latest PharmaReady Patch script. (Ensure PharmaReady latest SQL script is executed and reports are updated) 8.4. 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. Document Release date 18 th November 2013 Page 12 of 20

13 Comments: Reviewed By: Date: Document Release date 18 th November 2013 Page 13 of 20

14 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. Run prescan.exe in wss 2.0 database before taking backup and ensure no error. Download prescan.exe file from Microsoft website and keep it in folder in c drive as c:\prescan. Open command prompt and run the below command. 1. Navigate to prescan folder in c drive. 2. RUN prescan.exe /all command. Message will be displayed as operation completed successfully. Take the backup of SharePoint database and move it to 3.0 instances. 9.2 Create Temporary web application and site in SharePoint 3.0 instance server for migration. Open SharePoint 3.0 central admin page. Provide service account credentials if required. SharePoint central admin page opens. Document Release date 18 th November 2013 Page 14 of 20

15 Operation Tested & Verified By/ Date 9.3 Creating web application. Select Application management - > create or extend web application option. 1. Select create a new web application option. 2. In port Number field enter any port e.g or Description field will be updated automatically based on port number. 4. Under application pool, ensure configurable radio button is selected and PharmaReady service account user s name (domain\username) and password is given. 5. Under Reset Internet Information services, select Restart IIS Automatically radio button. 6. Under Database name and Authentication, Ensure Database server name is correct and provides the database name as WSS_Content_Temp1. 7. Click OK at bottom. Temporary database is created in SLQ and Application is created. 9.4 Creating site. 1. Click Create site collection in Application created page. 2. In create site collection page, provide title and description as Temp1. 3. Under Primary site collection administrator, provide PharmaReady service account username and click OK at bottom. Site has been created successfully. Click site URL and ensure the site is opening. Document Release date 18 th November 2013 Page 15 of 20

16 Operation Tested & Verified By/ Date 9.5 Restoring and attaching the 2.0 SharePoint database in 3.0 SLQ instance and migrating it into SharePoint 3.0 compatible. 1. Restore 2.0 SharePoint database in 3.0 sql instance. 2. Open SharePoint 2.0 central admin and go to Application management -> content database - > ensure the required web application selected at top and then select the content database - > enable remove content database checkbox and click ok. This step is to remove the default content database 3. Open command prompt and go to below location. C:\Program Files\Common Files\Microsoft Shared\web server extensions\12\bin 4. Execute the below command to attach and migrate the SharePoint 2.0 Database into SharePoint 3.0 compatible. stsadm -o addcontentdb -url - databasename contentdatabasename The database has been migrated successfully into SharePoint 3.0 compatible and ensures the sites open in 3.0 SharePoint instance. Document Release date 18 th November 2013 Page 16 of 20

17 Operation Tested & Verified By/ Date 9.5 Restoring and attaching the 3.0 SharePoint database in SharePoint 2010 SLQ instance and migrating it into SharePoint 2010 compatible. 1. Restore 3.0 SharePoint database in SharePoint 2010 installed sql instance as wss_content_live. 2. Open SharePoint 2010 central admin and go to Application management -> content database - > ensure the required web application selected at top and then select the content database - > enable remove content database checkbox and click ok. This step is to remove the default content database 3. 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 Open command prompt and go to below location. 1. C:\Program Files\Common Files\Microsoft Shared\web server extensions\14\bin 2 Execute the below command to attach and migrate the SharePoint 3.0 Database into SharePoint 2010 compatible. stsadm -o addcontentdb -url -databasename wss_content_live or Mount-SPContentDatabase WSS_Content_Live DatabaseServer SERVERNAME - WebApplication The database has been migrated successfully into SharePoint 3.0 compatable and ensures the sites open in 3.0 SharePoint instance. Document Release date 18 th November 2013 Page 17 of 20

18 Operation Tested & Verified By/ Date 9.1. 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 18 th November 2013 Page 18 of 20

19 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 18 th November 2013 Page 19 of 20

20 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 18 th November 2013 Page 20 of 20