Established in 2006, we bring one proven validation concept with our Pep 11 compliance tool to reduce costs and resources. Our core competency is to help our clients achieve and sustain compliance, meeting all global regulatory and data integrity requirements.
We bring in-depth knowledge of interpreting the Global GxP regulatory requirements and the current U.S. FDA compliance trends.
One validation Excel tool, PeP11 LabCal, was inspected by the FDA with no observations from the past ten years. We expanded our innovation to the word processor tool OC11 virtual solution (One Stop Global Regulatory Compliance tool) to achieve and sustain compliance. Word processors are widely used in the pharmaceutical industry to create forms and documents. Since OC11 is based on the word processor tool, which minimizes the learning curve, the user can transform any MS Word GxP document into a powerful virtual tool that helps the user prevent making compliance errors.
Data integrity ‒ requirements for complete, consistent, and accurate data.
Attributable - 21 CFR Parts, 211.101(d), 211.122, 211.186, 211.188(b)(11), and 212.50(c)(10)
Legible - 21 CFR Parts 211.180(e) and 212.110(b)
Contemporaneous - 21 CFR Parts 211.100(b) and 211.160(a)
Original or true copy - 21 CFR Parts 211.180 and 211.194(a)
Accurate - 21 CFR Parts 211.22(a), 211.68, 211.188, and 212.60(g)
Data Integrity Requirements