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In addition, quality management of electronic signatures and electronic records (1) (i.e., data generated by computer systems) is also part of the overall quality management system.

Computer systems must comply with c GMP requirements, when used in these regulated environments.

Learn more about Excel Safe Media Contact Ty Mew President Ofni Systems, Inc.The company’s products for computer validation, auditing and FDA submissions ensure that their clients meet all requirements for electronic records and electronic signatures.Ofni Systems provides live desktop support for superior customer support and training.Phone: (919) 844 – 2494 About Ofni Systems Ofni Systems is an industry leader for 21 CFR Part 11/Annex 11 compliance and automating the validation process.Started in 1999, their products for compliant databases and spreadsheets are used by the FDA, pharmaceutical, biotech and medical device companies across the globe.