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21 CFR §820.70(i) Automated Processes.

It's been mentioned that some companies are preferring to write their own code, build their own tools and trying to analyze their data using custom macros. I was reminded of the Food and Drug Authority, Code of Federal Regulations, Quality Systems Regulations for Production and Process Controls. 


21 CFR §820.70(i) Automated Processes.

When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.


That is all software used for quality activities needs to be validated for its intended purpose.

·        Validate computer software used as part of production or the quality system.

·        Validate according to an established protocol.

·        Validate all software changes before approval.

·        Document validation activities and results.


The validation can be quite simple, but you do need to validate against the intended purpose. In practice, that means developing a test plan, writing a protocol, conducting a test, analyzing the results, writing a report, having it peer reviewed and circulating for sign off, before publishing the final approved version.


There are many other Quality Management Systems regulations that require the same level of testing, verification and validation of automated software against requirements. If your company has Quality System Certification I'd strongly consider these requirements when developing custom software.

Bass Masri
BSc.(Math) MStat.
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