21 CFR Part 11 Compliance

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.

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. NextDocs applications and systems are designed according to the following regulatory controls criteria:

• Appropriate audit trails are generated and retained
• Only authorized access to records is permitted
• Any record and its audit log can be readily retrieved by an authorized person
• Proper operational sequences are followed, enforced by workflow and lifecycle
• Only qualified individuals are involved in the respective processes

NextDocs-developed technology provides digital electronic signature that is fully compliant with all signature requirements of the FDA as defined in 21 CFR Part 11. Our signature solution is also compliant with the more stringent “advanced electronic signature” requirements defined for Europe in DIRECTIVE 1999/93/EC of the European Parliament and of the Council, which requires signatures to be “based on a qualified certificate and which are created by a secure-signature-creation device”. Non-digital signatures do not meet this requirement.