Computer System Validation
Computer Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10.a. The FDA requires validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems. Failure to validate systems is one of the leading reasons a business is issued a 483.
Even though FDA has reduced some of its expectations regarding 21 CFR Part 11 compliance, (see the new guideline), the rules still apply for all critical computer systems. We can help you determine how to use a risk-based approach to prioritize your computer validation projects. We can also write the Master Plans, protocols, and final reports required.
Mtech’s validation specialists have experience working within the compliance requirements of established regulated companies. Our specialists are experts in industry validation standards and will produce validation documents which will meet or exceed your exacting standards.
Mtech uses the in-house templates to write validation documentation and execute Testing Protocols, which allows us to complete validation projects in less time than traditional validation methods, with more time spent testing your software and less time preparing documentation. Our goal in all software validation projects is to improve the quality and value of your computer system.
Mtech can validate all of your software, databases, spreadsheets and computer systems, and develop the appropriate documentation for all phases of the software life cycle. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. Mtech will perform risk assessments to focus the validation effort on the most appropriate sections of your system. We also have experience in validating LIMS, ERP-SAP and Middleware Oracle systems.
Step one of any Part 11 compliance program is to perform an assessment of your current systems to determine what is needed to bring them into compliance with FDA expectations. Our experts are current on all the latest trends. Our assessment reports are thorough and detailed with specific per system recommendations. We do not take a simple check list approach, but instead determine the aspects of the system that present regulatory or product quality risk and how to solve those issues.