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 August 1997.

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.