Record Retention - Instrument Printouts
Do laboratory instrument printouts need to be retained?
For non-waived testing, laboratory instrument printout data must be retained at least two years. These records may be paper or electronic, however they must be comprehensive. An acceptable example would be a data management system interfaced with the analyzer that provides retrievability of all information printed on the original hardcopy generated at the time of testing. If information printed on the hardcopy would not be retrievable from the computer system, then the hardcopy should be retained. Laboratories should also consider applicable state regulations which may be more stringent.
Last updated on April 11, 2016
Chapter: Document and Process Control DC