Regulatory Requirement

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As per 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.”

 

As per ISO 13485 Clause 7.5.2.1 “The organization shall establish documented procedures for the validation of the application of  computer software (and changes to such  software and/or its application) for production  and service provision that affect the ability of the product to conform to specified requirements.  Such software applications shall be validated prior to initial use.

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Is Spreadsheet (Excel sheet) considered as an Electronic Record?

 

Part 11 state as, “Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.”

 

The guidance document also state that “FDA considers part 11 to be applicable to…..  records that are required to be maintained under predicate rules, that are maintained in electronic format as well as paper format and this should relied to smooth running of regulatory inspection”.

 

 

Benefits of Excel Sheet Validation

 

All regulatory inspector required Spreadsheet Validation documents to check the reliability, accuracy, steady performance and the capacity to discriminate invalid result. As GP Excel expert team look out the validation as a prospectus to add-on value to your computer system and to maintain QMS at your workplace.

 

Regulatory compliant validation document allows you to

 

• Confidently submit the data to any regulatory agency

• To report quality of data

• Data accessibility

• Validated spreadsheet perform as per your specific requirement

• Track your data to step-up to your quality policy

• Have documented proof that your reported data as per the specification

• Help to maintain your QMS.