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SELCO Engineering has an extensive background in validation development, implementation, and documentation. Our experienced staff has the understanding of how important the FDA Regulations are to our customers.
The U.S. Food and Drug Administration (FDA) has defined the following:
"Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes."
-- (Guidelines on General Principals of Process Validation. FDA-1986)
21 CFR Part 11: Electronic Records; Electronic Signatures:
"The FDA regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations."
-- (FDA’s Federal Register 21 CFR Part 11 Rules and Regulations: March 1997)
Understanding and implementing a validation project that will be compliant with the FDA’s requirements can be challenging. SELCO Engineering provides our customers with the experience and knowledge required to address these challenges and develop a comprehensive validation plan and an in-depth design and testing strategy.
Our expertise includes extensive background in the following: