eFORMz and FDA 21 CFR 11 Compliance

The United States Food and Drug Administration enforces the Code of Federal Regulations Title 21, Part 11, which is commonly referred to as FDA 21 CFR 11. This regulation is titled Electronic Records: Electronic Signatures.

Part 11 requires that certain types of manufacturers, including those that manufacture pharmaceuticals and medical devices, must preserve data that is used in the production process. This regulation allows products to have an audit trail for better safety and tracking. Manufacturers should carefully consider how their software can support compliance with this regulation.

eFORMz can be a key component of your FDA 21 CFR 11-compliant solution that maintains accurate records, creates an auditable trail from supplier to customer, and powerful integration features to create barcodes, labels, and document archives.

For more information on how eFORMz can meet your compliance requirements, contact sales@minisoft.com.