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Part 11 Regulations

Controlled environments, such as laboratories or pharmaceutical industries, are required to comply with a number of regulations or standards, often times simultaneously. Regulations such as U.S. FDA Title 21 CFR Part 11, EU Annex 11, or other governing authority requirements pertaining to electronic records and signatures. These statutes standardize the use and expectations of computerized systems within these highly regulated industries; as well as set forth requirements needed to be fulfilled in order to allow electronic records and electronic signatures in lieu of traditional paper-based records and handwritten signatures

21 CFR Part 11 requires that persons who use closed systems to create or maintain electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and confidentiality of electronic records. Such procedures and controls include:

  • Validation of systems
  • Secure reliable storage
  • Computer generated audit trails
  • Changes shall not obscure previous data
  • Access control to the system
  • Electronic signatures

All statements used within Part 11 are related to computerized system which, as defined by the FDA, encompasses hardware, software, trained users and organizational procedures and policies.

Although compliance needs to be established by each institute for their particular business requirements and organizational structures and cannot be achieved by purchasing a certain device or software, CTL provides instrumentation and software solutions that enable their customers to comply with such regulations in their work.

Questions about Part 11?  Please contact us.

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