Faculty: John E. Lincoln
Data integrity has always been a key component of all the cGMP’s, only now taking on greater emphasis due to the use of electronic records / signatures. Cybersecurity is the preventing the theft / modification of e-records by unauthorized access. A growing concern for all – legal, financial, consumer, personal, and the FDA. t’s a recent concern for the medical products industries, a result of growing requirements for documentation / record keeping and companies increased reliance on networked electronic software, records and signatures.
The cGMPs have been around for decades. Electronic documentation requirements are newer. Initially there were regulations such as 21 CFR Part 11 in the U.S. and Annex 11 in Europe. But they are insufficient to prevent this growing threat. The FDA and news media have emphasized the prevalence of cybersecurity issues, such as data / identity theft, and hacking which pose hazards to many activities and businesses / industries.
Cybersecurity is an issue that will only increase over time, as records become more electronic, and communications are more networked or accessible to outsiders / hackers. As a result the FDA has mandated further requirements to be taken by regulated industries to better control data integrity and the cybersecurity threat, in validations, cGMP documentation, submissions to the Agency.
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