Q: We have some testers who prefer to type their test results; others like to hand-write their results.
Is there a rule of thumb for how best to record test results? Must they be handwritten? Or can the testers type the results and then initial and date them? I’d like to get your advice so I can add a policy to our Good Documentation Procedure.
A: You can use either one — typed or handwritten is fine for recording test results. It’s really all about how you handle the results form and what the form calls for.
Some companies have templates that can be downloaded, printed and completed by hand. Others have templates you complete by typing in the information, then printing and signing the forms.
Either way works for the FDA. If you have an electronic record system, you can type in the test results, save them to the electronic file and then sign and date them in the computer without the need to create paper.
Answered by Janis Olson, Vice President of Regulatory & Quality Services at EduQuest (22 years as an expert FDA investigator and as the FDA regional director of information management resources). Jan also is the co-instructor of EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 training class.