White Paper: Assessment Of Veriteq viewLinc Environmental Monitoring System Compliance To 21 CFR Part 11 Requirements

The 21 CFR Part 11 rule states that the FDA view is that the risks of falsification, misinterpretation, and change (without leaving evidence) within the GMP environment are higher with electronic records than paper records, and therefore specific controls are required.

The Veriteq validatable data logging system is a "hybrid" system that employs the use of both electronic records and signed paper records. The electronic records in the Veriteq system are controlled such that, once created, they cannot be modified. This unmodifiable nature of the electronic records allows them to be printed and signed with full assurance that they represent a true representation of collected data.

This white paper is a clause-by-clause analysis of the requirements of 21 CFR Part 11 and how the Veriteq viewLinc system responds to and helps users meet these requirements.