Electronic Signatures; Final Rule-FDA 21CFR Part 11

Checklist for the FDA Document : "FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures; Final Rule".

This checklist clarifies what is required for compliance to this standard by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of this standard.

The Checklist uses a classification scheme of physical evidence comprised of

• Procedure
• Plan
• Records
• Document
• Review
• Audit

When a company is planning to use this document to ensure their compliance to FDA 21 CFR Part 11, the company should review this evidence checklist.

This product supports these Software Engineering processes

• Acquisition
• Documentation
• Quality Assurance
• Safety

Customers of this product:

• Agilent Technologies
• Auxogyn, Inc.
• B&C Calibration Center Inc., Puerto Rico
• Baxter Healthcare
• Daiichi Asabi Pharmaceuticals
• Windy Hill Medical, Inc
• Environmental Systems Corporation
• Key Technology Inc.
• Lumina Engineering
• Miquest Limited
• Precision Interconnect
• Profit Technologies
• Sandvik
• Shiseido
• Sypris T&M
• Testo GmbH & Co., Germany
• Uptake Medical
• Vapotherm
• Veracity Medical Solutions

Note: “International Standards (ISO) define the best of practices for Medical Device and Software firms in producing a quality product. This checklist that SEPT produces will ensure that all of the best of practices are adhered to.”