Title 21 of the Code of Federal Regulations (CFR) is the Section of the United States government Rules and Regulations document that outlines rules associated with the Food and Drug Administration (FDA). Chapter I, Part 11, of this Section applies to records in electronic form, and to the criteria under which the FDA will consider electronic records and signatures "to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper
This final ruling, published nearly 25 years ago, established criteria for the use of electronic records and electronic signatures in complying with predicate rules 21 CFR Part 210 and 211. The ultimate goal is to provide the formal regulations for the submission of required documents to the agency [the FDA] in electronic format.
The purpose of this document is to describe the relevant portions of Part 11 regulations, and to explain their implementation using SimplicityChrom™ CDS. It is critical to understand that such support is not entirely the responsibility of PerkinElmer and the SimplicityChrom CDS software. As defined in the specifications of 21 CFR Part 11, it is also the responsibility of the persons using and implementing electronic records and electronic signatures to "employ procedures and controls designed to ensure the authenticity, integrity and, when appropriate, the confidentiality of electronic records." Proper procedures and practices are as much a part of overall compliance with these regulations as are the features of the SimplicityChrom CDS software. It is ultimately the customer’s responsibility to implement and maintain, in a compliant manner, any data system generating electronic records.
SimplicityChrom Chromatographic Data System (CDS) has been designed to perform chromatographic instrument control, data acquisition, data processing and reporting. In addition, SimplicityChrom CDS supports a wide range of built-in features to provide FDA regulated organizations the capability to comply with the requirements detailed in 21 CFR Part 11. SimplicityChrom CDS is designed to operate with the Microsoft Windows 10 operating system, providing users an even greater degree of security and access control. The combined functionality of the SimplicityChrom CDS software and the security features of the Windows operating system together offer the tools required to implement a technically compliant chromatography data system.
As stated earlier, it must be understood that the ultimate responsibility for operating a SimplicityChrom CDS environment in a compliant manner rests with the users of that system. The application of a SimplicityChrom CDS environment within the pharmaceutical industry is considered acceptable for 21 CFR Part 11 compliance, provided the functionality and security controls detailed in this document are applied and the principles of cGMP are not compromised.