Controlled environments, such as laboratories or pharmaceutical industries, are required to comply with different regulations such as US FDA GLP 21 CFR Part 11and other government authorities. Whereas GLP is primarily focusing on "good laboratory practices", Part 11 regulates the use of computerized systems within GxP-environments and sets 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.