PVS have much experience in all areas of validation documentation. We offer support in the key areas of documentation in the form of assistance, advice, formatting, providing templates or simply asking us to create your validation documentation to your specific needs. We can provide all these qualities to the following lifecycle and associated documentation:

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• Validation Policy and Site Validation Master Plans.

• Project Plans, Validation Master Plans and Reports.

• User Requirements Protocols / Reports / Specifications.

• Risk Assessments and Impact Assessments.

• Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).

• Design Qualification (DQ) Protocols and Reports.

• Installation Qualification (IQ) Protocols and Reports.

• Operational Qualification (OQ) Protocols and Reports.

• Performance Qualification (PQ) Protocols and Reports.

• Requirements Traceability Matrices (RTM).

• Periodic Reviews and Management of Periodic Reviews.

• Gap Analysis and Remediation Documentation.

 

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Archiving Assistance and Solutions:

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We also provide archiving advice and getting the best solutions in relation to building up an electronic validation database or managing a documentation area. 

 

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Testimonials:

 

‘PVS provided a contractual documentation service including Document Generation and Control and Management. They professionally liaised with representatives to provide excellent administration and project management’.

Kieran Sides, Validation In Partnership, Cheshire.

 

‘Dave (PVS) worked on a variety of equipment taking them through the typical stages of Design, Installation, Operational and Performance Qualification. This included the authoring, execution and reporting of all such documents and associated documents including impact assessments. I am happy to recommend David’ 

Karen Stevenson, Validation Manager, Patheon, Swindon.

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