21 CFR Part 11 guidelines help the pharma industry to be compliant with the predicate rules related to maintenance of electronic records and signature. It is the section of Code of Federal Regulations (CFR) which establishes guidelines for United States Food and Drug Administration (US FDA) related to electronic records and signatures. To ensure smooth audit process, it is essential for Pharma companies to be compliant to 21 CFR Part 11 guidelines.
Lot of paperwork is involved in the manufacturing and sales of pharma products. However, from the 21st century, electronic systems are slowly taking over a load of paperwork from the manufacturers. In the lieu with the same, manual records that are used for maintaining details of production are now being replaced with electronic records where the complete data is available in computers. This further led to the need for electronic signatures in place of manual signatures.
Electronic records are creation, modification, maintenance, archival, retrieval, transmission of data, text, pictorial, graphics, or any other information in digital form by a computer. On the other hand, electronic signatures are legally binding equivalent of a handwritten signature in the form of symbol or series of symbols.
Pharma industry can’t think of complete automation of the business process without being complaint to 21 CFR Part 11. Part 11 regulations mainly ensure to bring authenticity and avoid repudiation in the process. The regulations set by FDA has helped the life sciences organizations to streamline their business processes and reduce the turnaround time and costs by simply setting standard criteria for the use of electronic records and signatures.
If no such standard criteria were set, it would have been difficult for the pharma industries to manage records and other content electronically leading to increased risk of human errors, increase in costs and even increase in time taken to market the pharmaceutical products.
For the pharma industries to use electronic records and signatures in the business process, certain requirement criteria as per 21 CFR Part 11 guidelines need to be met.
CaliberLIMS has an in-built system that facilitates complete automation process without any hassles as it helps the customers to comply with 21 CFR Part 11.
A sample of some of the important functionalities including audit trail that are available in CaliberLIMS