PharmaReadyVersion 1.1

Installation Qualification - SPL Import Utility

/ PharmaReadySPL Import Utility™ Version 1.1
Installation Qualification – SPL Import Utility
Release Date: 6th January 2014
Document Number:SIQ01
Version 1.1, 12thJune 2014

Company Name: ______

Address: ______

______

______

Project Name: ______

Server Name:______

Server Location:______

IQ Prepared By: ______

Name / Title / Representing

______

Signature / Date

TABLE OF CONTENTS

1.Objective......

2.Procedure......

2.1.Prerequisites

2.2.Execution

2.3.Protocol Completion

2.4.Acceptance Criteria

3.Document Control......

4.Pre-IQ Approval from Customer......

5.IQ Roles and Responsibilities......

6.Execution Signature Verification......

7.PharmaReady Software Installation......

8.Post-Execution Approval......

9.Protocol Deviation Report......

1.Objective

This protocol outlines the requirements for the Installation Qualification (IQ) for SPL Import Utilityon the PharmaReady Server platform(s). The IQ protocol is developed by the manufacturer and defines the steps to install all necessary software components.

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.

2.Procedure

2.1.Prerequisites

  • All hardware, software, and infrastructure requirements must be completed.
  • Pre Upgrade checklist provided to customer
  • System Admin Supplemental Details form provided to customer

2.2.Execution

  • 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:
  • Header contains:
  • Project Name:
  • Version#:
  • Test Case Name: IQ-Server
  • Each Picture in Screen Capture Document
  • Test Case Step # above or below picture
  • 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.
  • 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:
  • The protocol step is inaccurate.
  • The data is entered incorrectly.
  • 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.

2.3.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.

2.4.Acceptance Criteria

  • Criteria for accepting the Installation Qualification phase as being complete are:
  • The IQ document has been executed and all screen captures are printed, labeled, initialed, and dated.
  • Any deviations encountered have a corresponding deviation report that is corrected or resolved.
  • The IQ document has been verified by a witness.
  • The IQ document has been reviewed by quality assurance or designee.
  • 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.

3.Document Control

Authored by: / Reviewed by: / Approved by:
Ashok John,
Implementation & Support Engineer / Date
23rd June 2014 / Rajesh Prabu
Implementation & Support Engineer / Date
23rd June 2014 / Vijay Srinivasan,
Sr. Implementation & Support Manager / Date
23rd June 2014

Revision History

Version / Date / Author / Remarks
1.0 / 23 Jan 2014 / Ashok John / Initial Version.

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)

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

7.PharmaReady Software Installation

Instructions: Install the PharmaReady SPL Import Utility software on the PharmaReady Server as instructed below and note any discrepancies in the Comments space provided.

Performed by: ______Date: ______

Verified by: ______Date: ______

Operation / Are Observed Results As Expected?
(Note Any Discrepancies) / Tested & Verified By/Date
7.1.Run Setup.exe from SPL IMPORT UTILITY Installation package.
Click Next and select everyone radio button
Click next to install spl import utility.
Expected Result:
SPL Import utility is Installed successfully.
7.2.Open SPLImportUtility.exe.config file from below location and update the PRConfig file location which is in Pharmaready folder.
For 32 bit: C:\Program Files\Take Solutions\SPL Import Utility
For 64 bit: C:\Program Files (x86)\Take Solutions\SPL Import Utility
Update the below prconfig location in SPLImportUtility.exe.config.
For 32 bit: C:\Program Files\Take Solutions\PharmaReady\PRConfig\PRConfig.Config
For 64 bit: C:\Program Files (x86)\Take Solutions\PharmaReady\PRConfig\PRConfig.Config
Expected Result:
PRCONFIG file location is updated sucessfully.
7.3 Run ServicesSTOP.cmd batch file from SPL import utility installation package.
Expected Result:
PREN SERVICE, PRPROCESS SERVICE,PRQM SERVICE AND PRECTDCOMPILE SERVICES STOP successfully.
7.3.Run the Deploy.cmd file to copy the SPL stylesheet
Expected Result:
File is copied successfully.
7.4.Run ServicesSTART.cmd batch file from SPL import utility installation package.
Expected Result:
  • PREN SERVICE, PRPROCESS SERVICE,PRQM SERVICE AND PRECTDCOMPILE SERVICES START successfully

7.5.Execute SPL Import Utility SQL Script in PharmaReady Database Server.
  • On the PharmaReady database server run theSPL Import Utility.sql script from the distribution media.
Expected Result:
SQL Management Studio shows “Query executed successfully”.
Comments:
Reviewed By: / Date:

8.Post-Execution Approval

The signatures below indicate approval of this executed protocol by TAKE Solutions.

Name / Signature / Company / Date

9.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: / Date:
Reviewed By: / Date:

Release Date – 6thJanuary 2014Page 1 of 10