21 CFR Part 11 Challenges And Solutions

Many sponsors are concerned with the risks and costs involved in ensuring that their electronic systems comply with the FDA’s ruling on acceptance of Electronic Records and Electronic Signatures in place of their paper equivalents (21 CFR Part 11). Although the ruling has been in place since 1997, there is often a lack of clarity concerning what characteristics and features a software solution must have to comply with 21 CFR Part 11. Even when a solution meets all of its requirements, ensuring that procedural requirements are met may be a bigger challenge.

Although sponsors’ concerns are certainly valid, Part 11 compliance also provides an opportunity. Sponsors and the FDA share a common goal of ensuring the integrity of their data, documentation and computer systems. If Part 11 compliance can be achieved by software configured to represent the sponsor’s desired business process, the burden on both system users and IT administrators can be minimal. The sponsor can then achieve benefits around both process automation and process transparency.

The intent of this paper is to describe how NextDocs products provide a built-in platform for 21 CFR Part 11 compliance while providing capabilities that allow sponsors to automate, monitor and control their processes.