Validation Outsourcing
People are very important in any business and often the people you have in your company either do not have the experience or the technical ability to take on complex or large scale laboratory projects. Many companies choose to outsource their validation projects in order to over come either their lack of resources or the lack of experience within their own pool of employees.

Smaller companies often assign many tasks to one person, who does not have the time, knowledge or experience to provide a quality service. Starting from scratch is not an easy task and a lot of time and effort can be wasted just getting started never mind the number of mistakes that will be made along the way.

We can advise on the proper course to take and guide you through the systems development life cycle, generation and review of documentation such as;

• Validation Master Plan
• Change Control Procedures
• In-house Analytical Testing
• Equipment Registration Procedures
• User Requirements Specification
• Functional Design Specifications
• Processes Mappings & Normalization
• Design Review
• Risk Assessment
• Test Scripts i.e. Calibrations, User Acceptance Tests, IQ, OQ and PQ protocols
• Requirements Traceability Matrix
• SOP's & Maintenance Procedures
• Business Contingency Procedures
• Administration and User Manuals
• Validation Summary Report

By having the involvement of an independent experienced technician in both the pharmaceutical and IT sector along with the ability to work with a project manager and coordinate the validation activities, we believe we can reduce your costs dramatically and reduced the lead time to return on investment whilst maintaining GMP compliance.

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