21 CFR Part 11 Compliance

Omicron has delivered many 21 CFR Part 11 compliance projects for the Pharmaceutical Industry. Omicron combines our expertise in pharmaceutical-specific business, technology, and regulatory requirements critical to implementing a risk-based approach to compliance. Omicron’s approach to Part 11 compliance will provide pharmaceutical companies with the ability to analyze processes and gaps across systems, which will in turn lead to the identification of better potential solutions.

Omicron has remediated existing systems and designed and implemented new systems that are cognizant of the risk-based approach, auditing requirements, security implications, and evidence reporting required by the regulation.

Omicron can also provide training with respect to 21 CFR Part 11 compliance issues. Omicron has delivered multiple 21 CFR Part 11 compliant projects in the Pharmaceutical Industry. Through our pharmaceutical clients, we have been involved with helping them understand the compliance issues with the final ruling of 21 CFR Part 11. Using this ruling, we have remediated existing systems and designed and implemented new systems that are cognizant of the auditing requirements, security implications, and evidence reporting.