The Perils Of Paper In An FDA-Regulated Environment
•Case Study: The Perils Of Paper In An FDA-Regulated Environment
According to Ken Miles of the FDA "One of the biggest challenges facing companies today is migrating from paper intensive systems to paperless electronic systems. The more involved companies get with their paper systems, the more they open themselves up to mistakes."
In March of 1997, the FDA published its final rule on electronic records, electronic signatures and audit trails. This rule – known as 21 CFR Part 11 – establishes the criteria under which the FDA recognizes electronic records and electronic signatures as the equivalent of paper records and traditional handwritten signatures.
Electronic records are essentially all of the quality records you maintain as well as other records you are required by regulation to submit to the FDA. An electronic signature is defined as "a computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature." Electronic signatures must include the signer's printed name, date and time stamp of signing, as well as the meaning of the signature – e.g. review, approval, acknowledgement, etc. Companies need to make sure to inform their employees that they understand the implications of electronic signatures and that any false activity on company records could result in criminal penalties.
When electronic records are in use, 21 CFR Part 11 requires that an audit trail be maintained automatically by the system. An audit trail provides a view-only, non-editable archive of all changes to the records. Users must not be allowed to circumvent it under any circumstances.
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•Case Study: The Perils Of Paper In An FDA-Regulated Environment
SOURCE: AssurX, Inc.