FDA 21 CFR Part 11 Compliance: How DocRead Helps Organizations Stay on Track

For companies that rely on electronic records and signatures, compliance with FDA 21 CFR Part 11 is non-negotiable. The regulation sets strict requirements to ensure that electronic records are trustworthy, reliable, and legally equivalent to paper records. It covers everything from secure user authentication to audit trails and, importantly, the training and acknowledgment processes that support system integrity.

This is where DocRead steps in. By enabling organizations to distribute, track, and manage policy acknowledgments and training, DocRead ensures staff are not only informed but also accountable when working with electronic systems. Two practical use cases stand out:

• SOP Acknowledgment: Organizations can distribute Standard Operating Procedures (SOPs) related to electronic systems and securely track acknowledgment from employees.
• Training on Electronic Systems: DocRead makes it easy to document that personnel have completed required training on systems that handle electronic records.

Many of our customers across industries are already leveraging these capabilities. In healthcare, for example, Maquet Australia and CoverMyMeds rely on SOP acknowledgment features to ensure clinical teams follow electronic processes accurately. In the technology sector, companies like Mavenir, Penthara, and Integra Optics use DocRead to train staff on complex systems that manage sensitive electronic records.

Manufacturers such as Cargolinx POC and Bruce Lynton use DocRead to align employees with electronic quality management procedures, while Polarcus in the energy sector ensures its teams remain compliant with industry-specific electronic reporting requirements. Even in non-profit and education, organizations like Northern Virginia Family Service and Magnimo Ltd benefit from the ability to reliably track acknowledgment and training in line with compliance standards.

For highly regulated industries, compliance with FDA 21 CFR Part 11 is both a challenge and a responsibility. DocRead simplifies this process, giving organizations confidence that their electronic records and signatures are supported by robust training, acknowledgment, and accountability.

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