Our dedicated validation and compliance consultants offer in-depth laboratory expertise and a full understanding of compliance requirements to help address issues such as 21 CFR Part 11. We provide validation consulting and planning, test development and execution, and validation training. With an in-depth knowledge of laboratory software and equipment, our consultants can help ensure laboratories meet compliance requirements in the most effective manner possible.
Our Validation Services provide access to dedicated resources with in depth product knowledge and extensive practical experience who deliver an effective, proven validation service for our software. The project risks and costs can be controlled with a clearly defined approach and project management throughout the process.
Service Details
We can provide a full suite of validation documents and services to support all aspects of your laboratory software validation. Our consultants use a library of base documents that can be tailored to meet client’s organizational standards and unique deployment attributes. Typical deliverables can include the Validation Plan, the User Requirements Specification, various protocols and test scripts, SOPs and recommended ancillary IT procedures.
Working jointly with our customers, our Validation Methodology is designed to satisfy the compliance needs of regulated industries. Our modular, scalable validation approach ensures that clients can choose the elements that are applicable to their validation project. Execution and documentation of the validation may be performed by any desired combination of client and Thermo Fisher Scientific personnel, with responsibilities clearly defined in a Validation Plan.
Our validation and compliance consultants offer specialized knowledge in a number of key areas:
Risk Assessment of laboratory software and processes.
Information technology – including software and applications, networking issues, operating systems and information security.
Validation for laboratory IT systems to achieve regulatory compliance with FDA, EPA, OECD and other regulatory GMP and GLP compliance standards.
Specific industry sectors, including detailed industry knowledge and experience in the regulated pharmaceutical and environmental sectors.
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