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21 CFR Part 11 Compliant Products
In 1992, members of the pharmaceutical and allied industries met with representatives
of the FDA to determine how they could accommodate paperless record systems. In July of
the following year the FDA published an advance notice of proposed rule making. Following
submissions from representatives of human and veterinary pharmaceutical companies, as well
as medical device, biological products, and food manufacturers, the final rule setting out
acceptance criteria for electronic records, and electronic signatures, was published in
21 CFR Part 11 is binding on all systems and applications that generate records in
support of FDA regulated activities, or submissions to the FDA. Additionally, the rule
is also binding on those systems that support electronic data communication with the FDA.
The regulation focuses on data security, integrity and traceability. By preparing and
submitting electronic records, a company is able to bring its products onto the market
much faster, thereby increasing profits. In contrast though, non-compliance with the
regulation will lead to regulatory scrutiny, costly rework and downtime, compromised
product quality resulting in product recalls or seizure, and prosecution.
Although the regulation is almost 5 years old, many FDA regulated industries are
still experiencing problems interpreting and implementing 21 CFR Part 11. Recognizing
the complexities involved in successfully implementing the rule and maintaining regulatory
compliance, we at Opulus have over many years developed the specialized knowledge, skills,
and highly trained staff necessary to ensure that our products and services to the
pharmaceutical and biomedical industries will greatly assist in achieving and maintaining
21 CFR Part 11 compliance.