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In this article we have listed critical details about compliance with Title 21 CFR Part 11.
Historically, companies maintained a paper trail of all their equipment, experiments and results in order to comply with cGMP (Current Good Manufacturing Practices) and cGLP (Current Good Laboratory Practices) regulations. Today, with increasing amount of automatization, digital records and computer managed equipment the volume of digital data created and transferred has rapidly surmounted what is still feasible to maintain in paper records. This situation calls for a radical switch from paper records to digital records.