Record Retention requirements of Calibration and Verification Service Providers

G

George Weiss

#11
The statement within the 21CFR820: In the general requirements section, stated "all parts of this part", which I gathered ment all of the parts of the refered to page. I would then include calibration documents, as the relate to the medical device testing directly or indirectly. Just my thought, and likely will be proven wrong.........................
 
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BradM

Staff member
Admin
#12
FDA Laboratory stores the QA Calibration Records for 3 years. Refer the Attachment A in the ORA Laboratory procedure.

.
To note from Ajit's most helpful post... 3 years is a minimum.

1. The retention period will not be less than five years or as governed by regulation or policy. Quality records will be retained for a minimum for three years.
2. Reports will be stored in a secure location with limited access. Computer based files are archived and stored for record keeping.
3. The following information should be available in laboratory data files:
• date, place, time of sampling and name of person who collected,
• identification of sample as to whether it is a routine or check sample,
• date of receipt of sample and date of analysis,
• laboratory and persons responsible for performing analysis,
• analytical technique and method used and quality control data, and
/ora/science_ref/lm/default.htm
• results of analysis.
Just establish a retention period for calibration records, and stick to it.:D Establish a pattern that can provide evidence that any instrument used during research/production did not have any adverse impact on the process. :agree1:
 
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