Validation Summary Report Template

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					Title     Validation Summary Report Template
Version   Status                                                      Date                     Page
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            Validation Summary Report
            Template




                                                 Document No:                Template_VS_0001_01
                                                 Prepared by:                 <Author>
                                                 Date:                       DD-MMM-YYYY
                                                 Version:                    1.0




            This document was printed 8-Jun-09. Prior to its use ensure that it is the most current version.
Title      Validation Summary Report Template
Version    Status                                                      Date                     Page
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                                  Document Approval

Name                      Role                  Date                     Signature
<Author>                  Author
                          IT
                          Validation
                          Client




                                      Document Control


Version    Author                     Date                        Description
1.0        <Author>                   DD-MMM-YYYY                 First Version




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                                                  Table of Contents



1       Introduction ______________________________________________________________ 4
    1.1     Objective ____________________________________________________________ 4
    1.2     Scope _______________________________________________________________ 4
    1.3     Definitions ___________________________________________________________ 4
    1.4     References ___________________________________________________________ 4
2       System Description ________________________________________________________ 6
3       Validation Activity Results __________________________________________________ 7
    3.1     Vendor Audits ________________________________________________________ 7
    3.2     21 CFR Part 11 Compliance ____________________________________________ 7
    3.3     Change Controls ______________________________________________________ 7
    3.4     Protocols ____________________________________________________________ 7
      3.4.1     Design Qualification ________________________________________________ 7
      3.4.2     Installation Qualification ____________________________________________ 8
      3.4.3     Operational Qualification ____________________________________________ 9
      3.4.4     Production Qualification____________________________________________ 10
4       Summary of Failures ______________________________________________________ 11
5       Acceptance Criteria _______________________________________________________ 12
6       Conclusion ______________________________________________________________ 13




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Title     Validation Summary Report Template
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1           Introduction

1.1         Objective
            Insert details of the objectives of the validation of the system.

1.2         Scope
            Insert a description the scope of the validation of the system.
            The description should include:
                     Any specific phases on the system implementation
                     Any specific servers that the system will reside on
                     The software development life cycle (SDLC used)
                     A definition of the post implementation validation process
                      PQ

1.3         Definitions
            Provide the definition of all terms and acronyms.

1.4         References
            This document contains references to one or more of the
            following SOPs.

            Document ID                    Title
            SOP_0100                       Implementation Life Cycle SOP
            SOP_0101                       SOP SOP
            SOP_0102                       Documentation Standards SOP
            SOP_0103                       Document Control SOP
            SOP_0104                       Configuration Specification SOP
            SOP_0105                       Environmental Naming Conventions SOP
            SOP_0106                       Incident Reporting SOP
            SOP_0107                       Access Authorization and Security SOP
            SOP_0108                       Computer Operations Manual SOP
            SOP_0109                       Backup and Archival SOP
            SOP_0110                       Disaster Recovery Plan SOP
            SOP_0111                       Vendor Audit SOP




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            Document ID                    Title
            SOP_0112                       Gathering Evidence SOP
            SOP_0113                       Configuration Management SOP
            SOP_0130                       Part 11 Conformance SOP
            SOP_0200                       Validation Determination SOP
            SOP_0300                       Validation Plan SOP
            SOP_0400                       Design Qualification SOP
            SOP_0401                       Code Review SOP
            SOP_0402                       Unit Testing SOP
            SOP_0500                       Installation Qualification SOP
            SOP_0501                       Installation Plan SOP
            SOP_0600                       Operational Qualification SOP
            SOP_0601                       Test Plan SOP
            SOP_0602                       Test Case SOP
            SOP_0700                       Validation Summary SOP
            SOP_0800                       Production Qualification SOP
            SOP_0900                       Validation Change Control SOP



            This document contains references to the following documents.

            Document ID                    Title
            XXXX_VD_0001                   Validation Determination Statement - <system name>
            XXXX_US_0001                   User Requirements - <system name>
            XXXX_VP_0001                   Validation Plan - <system name>
            XXXX_DQ_0001                   Design Qualification - <system name>
            XXXX_IQ_0001                   Installation Qualification (OQ Testing) - <system name>
            XXXX_OQ_0001                   Operation Qualification - <system name>
            XXXX_IQ_0002                   Installation Qualification (Production) - <system name>




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2           System Description
            The system description must describe:
                     The major functions of the system;
                     The interfaces to the system (application and human
                      interfaces);
                     The operating environment of the production system
                      including: the servers, the physical location, and the
                      network;
                     The hardware and software environment including:
                      servers, PCs, network, any peripheral devices specific,
                      and versions of operating system and application software
                      installed.
            If the above information is contained in existing documentation
            references to these documents may be used.




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3           Validation Activity Results

3.1         Vendor Audits
            Insert details of the results of any vendor audits.

3.2         21 CFR Part 11 Compliance
            Insert details the systems compliance with 21 CFR Part 11 and
            identify any areas where the system was found to be non-
            compliant and the containments put in place to address these
            areas of non-compliance.

3.3          Change Controls
            Change Control has been applied throughout the life of the
            project and will continue throughout the maintenance phase.
            The change control processes used during the project are listed
            below. Each document described includes a section for impact
            assessment and approved course of action.
            VCC – Validation Change Control. The VCC is used to assess
            changes to any environment after the DQ was completed.
            IR – Incident Report. Incident Reports were used to describe
            problems arising from Unit Testing, assessment of impact, and
            controlling documents for the required change. The Incident
            Report is stored with the test case from which the report
            originated. A log of Incident Reports is included in the test
            report associated with the series of testing.

3.4         Protocols

3.4.1       Design Qualification
            The Design Qualification provides documented evidence that the
            design of the system conforms to the standards laid down in the
            SDLC used and regulatory requirements. Identify the SDLC and
            the specific regulatory requirements.

3.4.1.1     Design Qualification


            Reference                Title                                                 Approved Date

            XXXX_DQ_0001             Design Qualification - <system name>



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3.4.2           Installation Qualification
                The Installation Qualification provides documented evidence that
                all key aspects of hardware and software installation meet the
                approved design specifications as intended and that the
                installation recommendations of the manufacturer/supplier have
                been suitably addressed.
                For this project the key items addressed were -
                         Computer Hardware
                         Server
                         Client PCs and desktop
                         Software
                         Operating Systems
                         Utility software
                         Application software
                         Configuration data
                         Static / dynamic data validation
                         Supporting documentation
                Approved installation plans and reports were prepared for each
                logical component of each environment that was qualified.
                IQ protocols were performed and recorded to confirm that the
                IQ Acceptance criteria were achieved for each of the
                Development, Validation and Production Environments.

3.4.2.1         Installation Qualification(s) (OQ Testing)


          Reference            Title                                                                         Approved Date

          XXXX_IQ_0001         Installation Qualification for OQ Testing - <system name>




3.4.2.2         Installation Qualification(s) (Production)


          Reference           Title                                                                        Approved Date




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          XXXX_IQ_0002        Installation Qualification for Production - <system name>




3.4.3           Operational Qualification
                All test plans and reports and Operational Qualification Protocols
                and Reports associated with the system were completed
                satisfactorily. The Operational Qualification provides
                documented evidence that the installed system operates as
                expected throughout normal and abnormal operating ranges.
                The OQ demonstrates that the configured system conforms to
                the agreed business process and functional design. The OQ
                includes testing configurations and business procedures specific
                to a site, such as unique set-ups for warehouses. The
                execution of the OQ Protocols was performed after the IQ was
                completed and the configuration defined for the relevant
                environment.
                The OQ was performed according to pre-approved test plans
                with defined acceptance criteria, using a qualified data set.
                The OQ demonstrates that the computerised processes
                (including manual operations that are formalised through a
                standard operating procedure (SOP) and are put in place to
                support the process) perform their required function and meet
                the agreed business requirement and Functional Requirement
                Specification.
                Test Cases were based on the agreed Business Process and
                Standard Operating Procedures (SOP) and Functional
                Requirement Specifications.
                Traceability matrices were contained within test plans and test
                cases.
                System SOPs were produced and refined after design and prior
                to implementation. Training in these procedures is recorded in
                personal training records.

3.4.3.1         OQ Protocols and Reports


                Reference                 Title                                                      Approved Date

                XXXX_OQ_0001              Operational Qualification - <system name>




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3.4.4           Production Qualification
                Production Qualification will be performed to a defined protocol,
                after the system is installed into the production environment.
                The PQ will demonstrate that the system maintains its validated
                status. The PQ will be performed at regular intervals after go
                live.
                This Validation Summary Report will be updated after this
                activity is complete to include the information provided by this
                phase.



3.4.4.1         PQ Protocols and Reports


          Reference            Title                                                              Approved Date

          XXXX_PQ_0001         Production Qualification - <system name>




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4           Summary of Failures
            Failures were analysed and classified during testing phases to
            assist with the management of testing. Impact assessments
            were performed during all phases of testing by relevant
            personnel. Failures were logged as Incident Reports or
            Validation Test Reports. Each assessment included a
            description, analysis, category of failure, impact assessment,
            and actual resolution. Typical classification included the
            following:
                     Protocol Error
                     Execution Error
                     Program Failure
                     Data set-up
            Detail the error by the above categories.




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5           Acceptance Criteria
            The Validation Plan for the system listed a number of
            acceptance criteria to be achieved in order to meet the
            requirements for validation. These are shown in the following
            table with the status of the requirement and a description of the
            impact on the validation status of the system.
            The system will be deemed acceptable when it satisfies the
            following criteria:


                   Description                                                        Achieved           Comment
                                                                                      Yes/No

            1




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6           Conclusion
            This section provides the conclusion(s) drawn from the
            validation effort. A statement may be written stating that the
            process is validated, that all predetermined
            specifications/acceptance criteria, etc. have been met, and that
            the process is substantially controlled and reproducible. The
            validation group signature on the Validation Summary Report
            serves to establish that the computer system is validated.




            This document was printed 8-Jun-09. Prior to its use ensure that it is the most current version.