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

Transcription

1 PharmaReady Version 6.0 Installation Qualification Client Workstation Document Number: PR-IQ-002 Doc Version 3.2, 24 th July 2017 Company Name: Address: Project Name: Server Name: Server Location: IQ Prepared By: Name / Title / Representing Signature / Date

2 TABLE OF CONTENTS 1. Objective Prerequisite Installation System Description Procedure Execution Protocol Completion Acceptance Criteria Document Control Revision History Pre-IQ Approval from Customer: IQ Roles and Responsibilities: Execution/Review Signature Verification PharmaReady Client Workstation Hardware Client Workstation Web Browser Settings Verification Supporting Softwares Installation Verification PharmaReady In-Place Editing Installation Verification POST-EXECUTION APPROVAL Protocol Deviation Report Page 2 of 17

3 1. OBJECTIVE This protocol outlines the requirements for the Installation Qualification (IQ) for software that needs to be installed on the PharmaReady client workstation(s) for the PharmaReady version 6.0. Successful completion of this protocol will provide assurance that the software is installed on the workstations in accordance with applicable manufacturer s recommendations. This protocol is a part of the overall validation effort for PharmaReady version 6.0 and will be used with the Operational Qualifications (OQ). IQ s and/or OQ s may be developed by the customer and in lieu of or in conjunction with the manufacturer s documents Prerequisite Installation This IQ presumes the Client workstation has been configured with a running version of Microsoft Windows (as specified below) and that the web browser to be used has been installed during the installation of Windows or by a later upgrade. 2. SYSTEM DESCRIPTION The PharmaReady software requires a client workstation which meets the following software and hardware prerequisites: Hardware: Software: Display: VGA, Super VGA, compatible with Windows Mouse: Microsoft Mouse or equivalent Other Devices: Fast Ethernet NIC Connection to the client s Intranet for internal access or secure method for accessing the PharmaReady server via the public Internet, VPN, or other access methodology. Microsoft Windows NT, 2000, Windows 7or XP Professional operating system. Internet Explorer version 8.0 and above Internet Explorer for Mac v5.2.3 (for client workstations using Apple hardware) Microsoft Office any version or other application tools that would be required to author and view documents stored in PharmaReady. Adobe Acrobat Standard / Professional any version (for ectd bookmarks and hyperlinks) (Applicable for ectd Module only) Adobe Reader any version that would be required to view the PDF documents published by PharmaReady. Page 3 of 17

4 3. PROCEDURE 3.1. Execution The customer will determine if the Installation Qualification is necessary. If necessary, NAVITAS LLP or the customer will execute the Installation Qualification at the customer location (onsite installs only). Print the Installation Qualification document. Follow the instructions for each table in this document. Document all results, reviews, verifications, and screen shots at the time they are. All screen prints must be created in a single MS Word document IQ Client Screen Capture Document. The IQ Client Screen Capture Document will be labeled with the following information: o Header contains: Project Name Version# Operational Qualification Script Name o Each Picture in Screen Capture Document OQ Script Step # above or below picture o Each Page of Screen Capture Document Validation Consultants Initials Executed Date Assemble IQ Client Screen Capture Document to the back of the applicable OQ Script Step. Validation Consultant The Validation Consultant writes their name in the Executed by field at the beginning of each section. The Validation Consultant enters Pass or Fail in the Observed Results As Expected column. If the expected results are not as expected write a deviation report. The Validation Consultant 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 Validation Consultant enters their initials and the date in the Executed & Verified By/ Date column to indicate an acceptable result. The Validation Consultant will label each screen print with the section identified, corresponding to results. Verifier The Verifier verifies the execution of the IQ Client 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 Executed & Verified By Date column for each section. The verifier will be the witness while Validation Consultant executes the protocol.(verifier can be either from NAVITAS LLP end or customer end). Page 4 of 17

5 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 Protocol Completion After completing the execution of the IQ Client, NAVITAS LLP will retain a photocopy of the completed IQ document and all supporting documentation for support purposes. NAVITAS LLP will provide original IQ documents to the customer. After completing the execution of the IQ Client, submit the completed protocol with supporting data and all deviation reports to the Quality Assurance Director / Manager Acceptance Criteria Criteria for accepting the IQ Client phase as being complete are: o The IQ document has been 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. Approval of the DMS Admin IQ indicates that the criteria outlined in this protocol have been met and indicates acceptance of the system. 4. DOCUMENT CONTROL Authored by: Reviewed by: Approved by: Janani S Validation Engineer Date 19-Jun Gopi T Validation Lead Date 23-Jun 2017 Vijay Srinivasan, Associate Program Manager- PharmaReady Date 24-Jul Page 5 of 17

6 5. REVISION HISTORY Version Date Author Remarks April 2009 Edwin Rodriguez Initial finalized version for Oct 2009 Edwin Rodriguez Initial finalized version for Jan 2012 Baskar Initial finalized version for May2012 Baskar Jan 2013 Baskar Initial Version for 5.1 Removed Settings which are not applicable for MS Office Nov 2014 Ashok John Finalized the OQ as per the 6.0 release April 2015 Ashok John Updated the verifier role Jun-2017 Janani S Updated the script errors as per validation team review comments and added Evidence Ref.# column to map the Evidence report 6. PRE-IQ APPROVAL FROM CUSTOMER: The signatures below indicate approval of this IQ for execution by authorized customer staff. Name/Title Signature Date Page 6 of 17

7 7. IQ ROLES AND RESPONSIBILITIES: Indicate each person s responsibility in the installation qualification protocol process. Name Title Role (Validation Consultant, Verifier, Reviewer, Approver) 8. EXECUTION/REVIEW SIGNATURE VERIFICATION Instructions: All personnel assigned to execute or review this protocol, attached exceptions and/or supporting documentation must sign and initial in the space provided below. Printed Name Signature and Initials Affiliation Page 7 of 17

8 9. PHARMAREADY CLIENT WORKSTATION HARDWARE Instructions: Provide information for all the hardware associated with the PharmaReady Client Workstation(s). Include manufacturer, model numbers, capacity, and ratings. This form may be reproduced as necessary. Executed by: Date: Verified by: Date: 9.1 Client Workstation Feature Value Are Observed Results As Expected? (Note Any Discrepancies) Evidence Ref. # Executed & Verified By/Date Manufacturer / Model No. Serial Number CPU Processor RAM Total Disk Space Client Machine Name Display Resolution Comments: Reviewed By: Date: Page 8 of 17

9 10. WEB BROWSER SETTINGS VERIFICATION Instructions: It is assumed the web browser software has been installed on the client workstation. Follow the instructions below to verify the proper installation and configuration and note any discrepancies in the Comments space provided. Executed by: Verified by: Date: Date: Operation Are Observed Results As Expected? (Note Any Discrepancies) Evidence Ref. # Executed & Verified By/ Date On the client workstation, open the Internet Explorer web browser by clicking on the Desktop shortcut or through the Start menu option. Select Help About Internet Explorer from the main menu. Verify that the displayed browser Version and Update Versions are as required for PharmaReady (IE 8 and above). The browser Version and Update Versions are in the list of supported versions Open Internet Explorer Tools Internet Options Under General Tab, Click on Settings within Browsing History, Under Temporary Internet Files, Ensure the first option (Every time I visit the Webpage) is selected. (Applicable for ectd module Only) Security Settings are changed. Page 9 of 17

10 Operation Are Observed Results As Expected? (Note Any Discrepancies) Evidence Ref. # Executed & Verified By/ Date Select Tools Options from the main menu. When the Internet Options window opens, select the Security tab. Add PharmaReady application web address into Trusted Sites Add file://pharmareadyservername into Trusted Sites PharmaReady application web address is added to Trusted Sites Select Tools Options from the main menu. When the Internet Options window opens, select the Privacy tab. Add PharmaReady application web address into Pop-Up Blocker allowed list. PharmaReady application web address is added to Popup blocker allowed list. Page 10 of 17

11 Operation Are Observed Results As Expected? (Note Any Discrepancies) Evidence Ref. # Executed & Verified By/ Date Open Internet Explorer Tools Internet Options Click the Security tab Select Trusted Sites Click Custom Level Ensure the following are set to Enable o Allow previously unused ActiveX controls to run without prompt o Allow scriptlets o Automatic prompting for ActiveX controls o Binary and script behaviours o Active Scripting, o Automatic Prompting for File Download (Not Applicable for versions above IE 8) o File Download o Access data sources across domains (Applicable for ectd and SPL modules Only) Security Settings are changed Open Internet Explorer (Applicable for ectd and SPL modules only) Tools Internet Options Click the Security tab Select Internet Click Custom Level Ensure Access data sources across domain is set to Enable Security Settings are changed. Page 11 of 17

12 Operation Are Observed Results As Expected? (Note Any Discrepancies) Evidence Ref. # Executed & Verified By/ Date From your Internet Explorer version 11 window, Go to Settings -> Compatible view settings. The compatible view settings window will get open. In "add this website" field, type the PharmaReady URL (for e.g. ) and click add. The PharmaReady URL will be added in the box "websites you've added to the compatibility view" successfully Ensure checkbox is ticked for below two options. Display all websites in compatibility view Display intranet sites in compatibility view Compatibility view settings are changed. Comments: Reviewed By: Date: Page 12 of 17

13 11. SUPPORTING SOFTWARES INSTALLATION VERIFICATION Instructions: It is assumed the Microsoft office, Adobe Reader and Adobe Acrobat has been installed on the client machine by the IT team at Customer location. Follow the instructions below to verify the proper installation and ask the IT team to install if not done already. Executed by: Verified by: Date: Date: Operation Are Observed Results As Expected? (Note Any Discrepancies) Evidence Ref. # Executed & Verified By/ Date On the client workstation, install Microsoft office and ensure Word, Excel, PowerPoint features are enabled. Note: Excel and Power Point features is optional while executing in server. Result: Microsoft Office was installed in Client machine On the client workstation, install Adobe Reader. Result: Adobe Reader is installed in Client machine. Comments: Reviewed By: Date: Page 13 of 17

14 12. PHARMAREADY IN-PLACE EDITING INSTALLATION VERIFICATION Instructions: Only necessary for client workstations that will be using the DMS In-Place Editing options for editing Office documents within PharmaReady. Complete the steps to allow the DMS In-Place Editing functionality to work on the PharmaReady Client as instructed below and note any discrepancies in the Comments space provided. This is applicable only for PharmaReady DMS installations. Executed by: Verified by: Date: Date: Operation Are Observed Results As Expected? (Note Any Discrepancies) Evidence Ref. # Executed & Verified By/ Date Obtain a copy of OfficeFrame.ocx (originally supplied in the OfficeFrame folder on the 6.0 Install Disk) Copy it to a folder on the client machine (recommended c:\windows\system32 for 32bit OS and c:\windows\ SysWoW64 for 64 bit OS). Open the command prompt and type Regsvr32 c:\windows\system32\officeframe.ocx A pop-up message will appear stating OfficeFrame.ocx file is registered on this machine. Page 14 of 17

15 Operation Are Observed Results As Expected? (Note Any Discrepancies) Evidence Ref. # Executed & Verified By/ Date Open Internet Explorer Tools Internet Options Click the Security tab Select Trusted Sites Click Custom Level Ensure the following are set to Enable o Initialize and script ActiveX controls not marked as safe o Run ActiveX controls and plug-ins o Script ActiveX controls marked safe for scripting Ensure the following are set to Prompt o Download unsigned ActiveX controls If your system has this option, ensure it is set to Enable o Run components not signed with Authenticode Click OK A popup message appears asking are you sure you want to change the security settings for this zone? o Click Yes Security settings are changed. Comments: Reviewed By: Date: Page 15 of 17

16 13. POST-EXECUTION APPROVAL The signatures below indicate approval of this Executed protocol by Navitas LLP. Name Signature Company Date Page 16 of 17

17 14. 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: Reviewed By: Date: Page 17 of 17