Computer systems used in FDA regulated environments must be able to accurately reproduce all system data in electronic and human readable forms.
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:
All computer systems need the ability to generate or export accurate and complete copies of records stored within them. Computer systems must be able to provide both electronic copies (export to file capabilities) as well as paper copies or printouts. If a computer system is able to export data to a file, it is assumed that the file may be printed. Audit trail information and any associated electronic signature information must also be available.
Verify that your computer system does not allow data to be modified without being tracked in the audit trail. Verify that data with regulatory impact can be retrieved from the computer, and that this data can be printed and exported to some electronic format. This is usually documented as part of the validation process.
Compare this requirement with Annex 11 Section 8., Printouts
Contact Ofni Systems if you need assistance with assessing your computer systems compliance status or implementing reporting functionality.
Q: What file formats are acceptable for file outputs?
A: The FDA does not have a list of acceptable file formats, but files provided to an FDA regulator should be able to be read by that regulator. Ofni Systems recommends using common file formats, such as TXT, DOC, XLS, etc. wherever technologically possible. Converting files to a PDF format is a good technique to ensure that provided data is not accidentally altered.
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