Company Name: Address: Project Name: Server Name: Server Location:

Transcription

1 PharmaReady Version 6.0 Installation Qualification Tenant Setup Document Number: IQ39 Doc Version 1.1, 15 th Jan 2018 Company Name: Address: Project Name: Server Name: Server Location: IQ Prepared By: Name / Title / Representing Signature / Date

2 TABLE OF CONTENTS 1. Objective Procedure Prerequisites Execution Protocol Completion Acceptance Criteria Document Control Revision History Pre-IQ Approval from Customer: IQ Roles and Responsibilities: Execution/Review Signature Verification PharmaReady Hardware PharmaReady Server PharmaReady Software Installation Network Share Availability Qualification Post-Execution Approval Protocol Deviation Report Page 2 of 23

3 1. OBJECTIVE This protocol outlines the requirements for the Installation Qualification (IQ) for a new installation of the PharmaReady version 6.0 software on the PharmaReady Server platform(s). The IQ 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 6.0 and will be used with the al Qualifications (OQ). 2. PROCEDURE 2.1. Prerequisites 2.2. Execution All hardware, software, and infrastructure requirements must be completed. Pre install 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. Tester The Tester writes their name in the performed by field at the beginning of each section. The Tester enters Pass or Fail in the Observed 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 Verified By/ Date column to indicate an acceptable result. The Tester will label each screen print with the section identified, corresponding to results. Page 3 of 23

4 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. The verifier will sign in the Verified By Date column for each section. The verifier will be the witness while tester executes the protocol.(verifier can be either from Navitas end or customer end). Reviewer The Customer QA/Regulatory 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 2.3. Protocol Completion After completing the execution of the IQ, NAVITAS LLP will retain a photocopy of the completed IQ document and all supporting documentation for support purposes. NAVITAS LLP 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 Director / Manager 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 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: Ajay Kumar R Implementation and Support Engineer 15 th January 2018 Ashok J Implementation and Support Engineer 15 th January 2018 Vijay Srinivasan, Associate Program Manager PharmaReady 15 th January 2018 Page 4 of 23

5 4. REVISION HISTORY Version Date Author Remarks January 2018 Ajay Kumar R Initial version of document 5. PRE-IQ APPROVAL FROM CUSTOMER: The signatures below indicate approval of this IQ for execution by authorized customer staff. Name/Title Signature Date 6. IQ ROLES AND RESPONSIBILITIES: Indicate each person s responsibility in the installation qualification protocol process. Name Title Role (Tester, Verifier, Reviewer, Approver) Page 5 of 23

6 7. EXECUTION/REVIEW 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 Page 6 of 23

7 8. PHARMAREADY HARDWARE Instructions: Provide information for all the hardware associated with the PharmaReady Server(s) and optional Database Server. Include manufacturer, model numbers, capacity, and ratings. This form may be reproduced as necessary. Performed by: Date: Verified by: Date: 8.1 PharmaReady Server Feature Value Verified By/Date Manufacturer / Model No. Serial Number CPU Processor RAM Total Disk Space RAID Configuration Comments: Reviewed By: Date: Page 7 of 23

8 9. PHARMAREADY SOFTWARE INSTALLATION Instructions: Install the PharmaReady software on the PharmaReady Server as instructed below and note any discrepancies in the Comments space provided. Performed by: Verified by: Date: Date: Verified By/ Date 9.1. Stop IIS and PharmaReady Services. On the PharmaReady server run the ServicesSTOP.bat program from the distribution media. Note: Right Click on ServiceSTOP.bat file and choose Run as administrator option. Ensure Required Backups are taken before executing these steps. IIS and PharmaReady dependent services were stopped Restore PharmaReady blank database from PharmaReady installation package with name in below format PharmaReady_TenantName Once database has been restored, remove pradmin user from restored database and execute below query one by one. EXEC sp_addlogin 'pradmin', 'Keep0ut!', 'PharmaReady' EXEC sp_grantdbaccess 'pradmin' EXEC sp_addrolemember 'db_owner', 'pradmin' The PharmaReady Installer window closes and database is restored successfully. Page 8 of 23

9 Verified By/ Date 9.3. Create a shared folder for the ectd module. (Only for PharmaReady ectd Installations.) On the PharmaReady Server run Start My Computer select a local non-removable disk (e.g. Local Disk C: ). Select File->New->Folder Name the folder ectdcompile_tenantname Right click on the ectdcompile_tenant folder. Select the Sharing tab and click Share This Folder Select Permissions button and add the machine Users (i.e. <PharmaReadyServer>\Users) give that group full control. Select the Security tab. Select Users group. Select Full Control Allow checkbox. Click Ok. Create a folder named ectdneesdocuments under ectdcompile_tenant folder. Expected Results: The ectdcompile_tenant share will be created and users group will be assigned all access rights Create a shared folder for the SPL module. (Only for PharmaReady SPL Installations.) On the PharmaReady Server run Start My Computer select a local non-removable disk (e.g. Local Disk C: ). Select File->New->Folder. Name the folder SPLPublish_TenantName Right click on the SPLPublish_Tenant folder. Select the Sharing tab and click Share this Folder Select Permissions button and add the machine Users and give it full control. Select Full Control Allow checkbox. Click Ok. Expected Results: The SPLPublish_Tenant share will be created and users group will be assigned all access rights. Page 9 of 23

10 Verified By/ Date 9.5. Create shared folders for the ectd module. (Only for PharmaReady ectd Installations.) On the PharmaReady Server run Start My Computer select a local non-removable disk (e.g. Local Disk C: ). Select File->New->Folder. Name the folder ectddocuments_tenantname Right click on the ectddocuments_tenant folder. Select the Sharing tab and click Share This Folder Select Permissions button and add the PharmaReady Service account. Select the Security tab. Select PharmaReady Service account and check Full Control Allow checkbox. Click Ok. Create a folder named ectdtempdocuments under ectddocuments folder. Expected Results: The ectddocuments_tenant, ectdneesdocuments and ectdtempdocuments share will be created and PharmaReady Service account will be assigned all access rights. Page 10 of 23

11 Verified By/ Date 9.6. On the PharmaReady Server run Start My Computer select a local non-removable disk (e.g. Local Disk C: ). Select File->New->Folder Name the folder CVDocuments_Tenant Right click on the CVDocuments_Tenant folder. Select the Sharing tab and click Share This Folder Select Permissions button and add the machine Users (i.e. <PharmaReadyServer>\Users) give that group full control. Select the Security tab. Select Users group. Select Full Control Allow checkbox. Click Ok. The CVDocuments_Tenant share will be created and PharmaReady Service account will be assigned all access rights. Page 11 of 23

12 Verified By/ Date 9.7. Update entries in PRConfig.config file. Edit the PRConfig.config file (located by default in C:\Program Files (x86)\take Solutions\PharmaReady\PRConfig) Update the following content between <appsettings> </appsettings> PRConfig.config file. <add key="tenants" value="client1.navitasnetworks.com, client2.navitasnetworks.com" /> <add key="client1.navitasnetworks.com_pdfserviceurl" value=" /> <add key="client1.navitasnetworks.com_pharmareadyconne ctionstring" value=" " /> <add key="client1.navitasnetworks.com_ectddocumentloca tion" value="\\servername\ectddocuments_tenantname" /> <add key="client1.navitasnetworks.com_ectdtemplatedocu mentlocation" value="\\servername\ectdtempdocuments " /> <add key="client1.navitasnetworks.com_ectdneeslocation" value="\\servername\ectdneesdocuments " /> <add key="client1.navitasnetworks.com_cvdocumentlocatio n" value="\\servername\ectdcvdocuments_tenantna me" /> Page 12 of 23

13 Verified By/ Date <add key="client1.navitasnetworks.com_prqmhomedirector y" value=" D:\PRQM_TenantName " /> <add key="licensee" value="tenantname" /> Save the configuration file. PRconfig is updated successfully Update Machine.config file. Copy the content between <appsettings> </appsettings> from prconfig.config file and paste it into below machine.config files between <appsettings> </appsettings> C:\Windows\Microsoft.NET\Framework\v \CONFIG\mac hine.config C:\Windows\Microsoft.NET\Framework\v \Config\machi ne.config C:\Windows\Microsoft.NET\Framework64\v \Config\ma chine.config Machine.config files are updated successfully. Page 13 of 23

14 Verified By/ Date 9.9. On the PharmaReady Server run Start My Computer select Local Disk (D/E:). Make another copy of PRQM folder Rename the PRQM Copy folder to PRQM_TenantName Right click on the PRQM_TenantName folder Select properties. Select the Security tab. Select Users Group. Select the Full Control Allow Check box. Click Ok to close the properties dialog. Expected Results: The Users group will be assigned all access rights On the PharmaReady Server run the program (D or E): \PRQM_TenantName\bin\PRQMStatus.exe (Initial Tenant s PRQM Folder) Select the Settings tab Set the following settings: Home Folder: Select the Created Tenant from dropdown Scan Interval: 5000 Max Processes: 1 Process Timeout: 2000 Click Save Settings to save the defaults. Click Ok on the response dialog. Click Close. Expected Results: The PRQMStatus saves the correct configuration settings Create a Host Entry on IIS PharmaReady Site Right Click on PharmaReady Site and choose Edit Bindings Add the Tenant Specific URL and save it. Tenant URL is added in PharmaReady Site Bindings Page 14 of 23

15 Verified By/ Date Start IIS and PharmaReady Services. On the PharmaReady server run the ServicesSTART.bat program from the distribution media. Note: Right Click on ServiceSTART.bat file and choose Run as administrator option. IIS and PharmaReady dependent services were started Update 6.x version license key (If Applicable). License Key is updated successfully Record PharmaReady support info From a client computer, launch Internet Explorer, and navigate the web browser to the PharmaReady Logon page. Click on the `About button. Record the following information. Take a screen print and save a screenshot of the information page. Version: Build: Date: License Mode: DMS Module: TRMS Module: e-ctd Module: SPL Module: The PharmaReady Support information is captured Page 15 of 23

16 Verified By/ Date Next you need to Logon into PharmaReady and setup key initial fields/information. Load PharmaReady by entering the DNS entry for the PharmaReady server into your Web Browser. On the PharmaReady Logon screen logon as Admin with password password. Next go to Systems Settings page by navigating to the Admin menu then down to the System Settings submenu. Enter the required fields: Alias Notification Invalid Logon Notify Enter the information for the PharmaReady service account. Default Domain Default UserName Default Password If DMS is enabled Add a path for local edits. This should be the same as the folder created above (e.g. <drive letter>:\prdocuments) Local Save Directory Add a path for remote edits. This will be the share that maps to the path above (e.g. \\<server name>\prdocuments) Remote Save Directory Click Submit to save. Page 16 of 23

17 Verified By/ Date If ectd is enabled Go to Systems Settings page by navigating to the Admin menu then down to the System Settings sub-menu from PharmaReady ectd Home Page. Enter the share name created earlier in the format \\<server>\<sharename> Compile Directory If SPL is enabled Go to Systems Settings page by navigating to the Admin menu then down to the System Settings sub-menu from PharmaReady SPL Home Page. Enter the share name created earlier in the format \\<server>\<sharename> Publish Directory Click Submit to save. Expected Results: Required System Settings and logon credentials for use by PharmaReady will be successfully saved. Page 17 of 23

18 Verified By/ Date Create Re-indexing Maintenance Plan. Open the services administration tool from Start Administrative Tools Services. In properties for the SQL Server Agent service, set the service to run as Automatic and start the service. Start the service, and close the services console. Open SQL Server Management Studio When prompted, ensure that the correct SQL Server Name and credentials are entered and then click `Connect. Expand Management; right click Maintenance Plans and select Maintenance Plan Wizard and click Next when the wizard launches. Enter Rebuild PharmaReady Indexes_TenantName as the Name. Click the Change button. Set the Frequency Occurs to Daily. Set the Occurs once at option to 3:00 A.M (or other appropriate schedule as determined by the customer s IT staff). Enter the scheduled time: Click OK and Next when the wizard is redisplayed. Select Rebuild Index and click Next. Click Next on the Select Maintenance Task Order page. Select PharmaReady_TenantName from the Databases dropdown. Leave the Advanced options unchecked, and click Next. Leave the Write a report option checked and leave the default folder. (This can be altered by the IT staff at a later date if log files are not desired.) Click Next. Click Finish. Click Close when the wizard completes. The Maintenance Plan is created and scheduled to run nightly. Page 18 of 23

19 Verified By/ Date Create Backup Maintenance Plan. Open SQL Server Management Studio When prompted, ensure that the correct SQL Server Name and credentials are entered and then click `Connect. Expand Management; right click Maintenance Plans and select Maintenance Plan Wizard and click Next when the wizard launches. Enter Pharmaready DB Backup_TenantName as the Name. Click the Change button. Set the Frequency Occurs to Daily. Set the Occurs once at option to 4:00 A.M (or other appropriate schedule as determined by the customer s IT staff). Enter the scheduled time: Click OK and Next when the wizard is redisplayed. Select Database backup full and click Next. Click Next on the Select Maintenance Task Order page. Select PharmaReady_TenantName from the Databases dropdown. Leave the Advanced options unchecked, and click Next. Leave the Write a report option checked and leave the default folder. (This can be altered by the IT staff at a later date if log files are not desired.) Click Next. Click Finish. Click Close when the wizard completes. The Backup Plan is created and scheduled to run nightly. Page 19 of 23

20 Comments: Reviewed By: Date: Page 20 of 23

21 10. NETWORK SHARE AVAILABILITY QUALIFICATION Instructions: Qualify PharmaReady service account has applicable permissions, follow instruction below and note any discrepancies in the Comments space provided. Performed by: Verified by: Date: Date: Results As Verified By/ Date Ensure that there is a shared folder in which the PharmaReady service account can read and create files for Archiving, Batch Uploading, etc. Share Path: (\\servername\sharename_tenantanme\) The PharmaReady service account has permission to read and create files in the network share. Comments: Reviewed By: Date: Page 21 of 23

22 11. POST-EXECUTION APPROVAL The customer signatures below indicate approval of this executed protocol by NAVITAS LLP. Name Signature Company Date Page 22 of 23

23 12. 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: Page 23 of 23