What 21 CFR part 11 means about computer systems

Salesforce 21 CFR part 11

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Pharmaceutical and healthcare industries that operate under the aegis of FDA cannot simply do without system validation. According to 21 CFR part 11, the document issued by FDA to establish the regulations related to electronic documents and electronic signatures, any software that you use in the operations of the business for processes linked to the delivery of the final product should be validated.

Each title of the CFR pertains to different regulated areas. 21 CFR is related to pharma and medical devices with part 11 specifically related to electronic documents and electronic signatures. Therefore, any software that has any relation to Good Manufacturing Process (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) has to be validated as part of system validation.  This means that you must use Salesforce 21 CFR part 11 compliant software or something similar.  In this article, we will discuss the implication of the law about computer systems.

What computer systems need to be compliant?

According to the FDA guidelines, if you are using closed computer systems, you must have proper procedural and technological controls for data protection within the system. The same applies to open computer systems to ensure that all records are incorruptible and authentic besides maintaining its confidentiality.

Which systems need validation?

All computer systems that store data related to the quality system used for making quality decisions or any data that needs reporting to FDA must undergo proper validation for compliance with the regulations.  In the manufacturing area, if the data relates to decisions about product quality and product release is needs validation. Any data about laboratory results that lead to a determination of efficacy, strength, purity, safety, and quality must come from a validated system.  Similarly, data related to clinical trials come under the same category.

Validation of computer system

The first requirement of 21 CFR part 11 is computer validation that sets the ball rolling. Validation is the process of methodical documentation of system requirements together with documented testing to demonstrate that the computer system is capable of meeting the documented requirements.  For validating the computer system, you must maintain all valid documents including testing protocols and requirement specifications. Computer programs of all types whether it is software or web based and whether it is MS Access database or MS Excel spreadsheet must go through the same process of validation.

Accuracy or records and protection

FDA insists that records generated in the system must be accurate. Here, accuracy means that the record must be completely retrievable without any alteration or changes, which even if one has to be registered. To know how accurate the record is, you can verify the record in the system for proper display, which remains as much accurate even when exported. Electronics record should never corrupt, and during the period of its retention, its retrieval must be comfortable. You can put procedural and technological controls in place to achieve this.

It makes sense to treat computer validation more than mere compliance because it enhances quality and effectiveness of the system.

About the author:

Lucy Jones is a computer expert who has worked alongside FDA inspectors in implementing the regulatory framework in industries. Her stint with Flosum.com helped him to get exposure on the Salesforce platform.  She is a specialist in regulated software applications.

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