Validation Summary SOP

Transcription

1 1.0 Commercial in Confidence 03-Aug of 9 Validation Summary SOP Document No: SOP_0700 Prepared by: David Brown Date: 03-Aug-2006 Version: 1.0

2 1.0 Commercial in Confidence 03-Aug of 9 Document Approval Name Role Date Signature David Brown Author Document Control Version Author Date Description 1.0 David Brown 03-Aug-2006 Version 1

3 1.0 Commercial in Confidence 03-Aug of 9 Table of Contents 1 Introduction Purpose Scope Definitions Responsibility References Validation Summary Process Validation Summary - Phase Entry/Exit Phase Entry Phase Exit Validation Summary Report Content - Procedure Validation Summary Report Title Approval Introduction Scope Definitions References Computer System Description Validation Activity Results Summary of Failures Conclusion...9

4 Title Validation Summary SOP 1.0 Commercial in Confidence 03-Aug of 9 1 Introduction 1.1 Purpose This SOP provides guidance for the validation summary process and the purpose and minimum content requirements for a Validation Summary Report (VSR). 1.2 Scope Department/Section: Validation group This SOP applies to all computer systems requiring validation. 1.3 Definitions Project Team - The group of associates that come together for a specific purpose. The group maybe composed of business clients, Support, Validation, and other areas necessary to the successful completion of a project. Client the business system owner is typically the line manager responsible for the business process where the computer system will be used. Validation Group the group responsible for ensuring that computer systems are implemented and maintained in a validated state. IT Group the group responsible for development, operation, and maintenance of computer systems. 1.4 Responsibility Validation and the other disciplines listed within this SOP are responsible for ensuring this procedure is followed. 1.5 References Document ID SOP_0400 SOP_0500 SOP_0600 SOP_0700 Title Design Qualification SOP Installation Qualification SOP Operational Qualification SOP Production Qualification SOP

5 1.0 Commercial in Confidence 03-Aug of 9 2 Validation Summary Process The validation summary phase is led by the validation group. The main aim is to summaries the results of the validation process required for the computer system. The tasks required during this phase are: 1. The review of the results of each phase of the validation process (Validation Planning, Design, Installation(s), and Operational Qualifications); 2. The identification of any issues that where experienced during the validation process; 3. The identification of any constraints and limitations that must placed on the systems ability to manage data and processes related to regulated activities. 4. Identification of the operational SOPs, manuals, and Production Qualification(s) required ensuring the system remains validated when live. 5. Preparation of a Validation Summary Report documenting the outputs of the above activities. 6. The approval of the Validation Summary Report by all of the stakeholders identified in the validation plan.

6 1.0 Commercial in Confidence 03-Aug of 9 3 Validation Summary - Phase Entry/Exit 3.1 Phase Entry The entry point for the validation summary process is the approval of the Production Installation Qualification. 3.2 Phase Exit The exit point for the validation summary phase is the approval of the Validation Summary Report.

7 1.0 Commercial in Confidence 03-Aug of 9 4 Validation Summary Report Content - Procedure The purpose of the Validation Summary Report (VSR) is to provide an executive summary of all of the DQ, IQ, OQ, protocols and other activities described in the appropriate Validation Plan and which were performed to complete validation of the computer system. The Validation Summary Report is approved after formal validation activities have been completed. The master summary is prepared by members of the validation group or trained designees. The VSR must conform to SOP_0102 Document Standards SOP. At a minimum, the following sections are required in the Validation Summary Report: 4.1 Validation Summary Report Title 4.2 Approval Give the VSR a descriptive title that uniquely identifies the system. At the beginning of the Validation Summary Report an approval section is required. This section will contain a table for signatures. The table of signatures must provide for the following information to be captured: 1. The department or function of the signatory; 2. The name of the signatory; 3. A space to record the signature, and; 4. A space to record the date of the signature. The section must contain a statement informing the reviewer that signing this document infers that they have read, understood and agree with the contents of the VSR. Normally this information is collected on the approval page of the VSR. 4.3 Introduction This section is a brief introduction of the product, process, equipment and/or system that have been validated.

8 1.0 Commercial in Confidence 03-Aug of Scope The scope of the VSR must be clearly stated. The business function that the system addresses and the components of the system that have been validated through the validation plan must be identified. 4.5 Definitions A section providing a glossary of terms used in the document must be provided. 4.6 References A section providing a list of document references must be provided. 4.7 Computer System Description This section is essentially the same description found in the Validation Plan and provides a detailed description of the computer system which has been validated. The section should be in sufficient detail for all major functions of the system to be clearly understood. References to other documentation such as procedures, user operator manuals or technical documents may be made to indicate detailed functionality. Unique system ID should also be provided. 4.8 Validation Activity Results This section includes summaries of all of the DQ IQ, OQ protocols and other activities described in the appropriate Validation Plan and which were performed to complete validation of the computer system. Filenames and titles along with the final approval dates should be included in the summaries. Any critical supporting utilities or services, which had not been previously listed, should also be described including the validation status of those systems directly involved with the process that has been validated. For example, information related to the source code control system used. 4.9 Summary of Failures This section provides a summary of all deviations to the Validation Plan encountered while performing the activities of plan. The deviation should be described as well as the reason,

9 1.0 Commercial in Confidence 03-Aug of 9 corrective actions/investigations taken to resolve the deviation and/or rationale on why the activity planned was not required. In addition, final results after the corrective actions were taken should be discussed. PQ deviations may be listed in this section if appropriate 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.