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Electronic Documents and Systems Needs Validation for Use in Regulated Industry

Computers have changed the business scene so much that it has now become almost entirely digital. We have become used to plastic money and companies are striving to make all transactions paperless as businesses make rapid strides by embracing technology in a bigger way.  It is almost impossible to even dream of any business set up that does not use computers today. Along with the use of computers comes the responsibility of developing systems that comply with the regulatory requirements, particularly for industries that come under the direct control of FDA (Food and Drugs Administration). The pharma and healthcare industries have to shoulder additional responsibility in choosing the correct software that is capable of operating within the regulatory framework that ensures compliance with the regulatory guidelines. The context of regulating the use of electronic documents would be apparent on reading this article.

Electronic documents – why to control it

Why did the FDA feel it necessary to control electronic records? For the simple reason that electronic documents are most susceptible to forgery and manipulation and it is challenging to distinguish between a genuine and fake document. Whether it is text or images, you can make unwarranted changes to it and damage its authenticity which is why FDA has put rules in place to ensure that the documents generated by the system are completely authentic. By following the regulations, you can track a document right from the time it is born throughout the course it traverses and whatever changes happen to is recorded. And not the documents alone, but the entire system undergoes sanitization and validation to comply with the FDA regulations as defined in FDA 21 CFR part 11.

An extension of Good Manufacturing Practices

The FDA regulations aim at creating a uniform system of manufacturing in the pharma and allied industries so that it provides a level playing field for all.  Companies that follow Good Manufacturing Practices (GMP) ensure that they adopt the best practices of the industry and the quality of goods manufactured is always at par with the best in the industry.  Since all activities of regulated companies are under close surveillance of FDA, it is only natural that they would take a similar approach for controlling electronic documents and signatures. The controls that exist for paper documents logically extend for electronic documentation so that there is parity with the overall philosophy of control.

Software that is ready for validation

The FDA guidelines cover electronic systems and documents as well as electronic signatures for which the software used for the system automatically comes under regulatory control. Salesforce qualifies for use in regulated industry because it carries the mark Salesforce 21 CFR part 11, which is a sign of its validation ready feature that makes it fit for adopting the best practices of the industry.  Standard operating procedures (SOP) for every activity carried out concerning the generation of electronic documents, and electronic signatures facilitate the system validation and ensure data integrity.

Using validated software gives you the opportunity of staying tunes with the best practices of the industry that augurs growth.

Author Bio:

Lucy Jones is an FDA consultant. With a background in chemical engineering, she has served many pharma and software companies including Flosum.com before taking up an independent profession. A fitness freak, he hits the gym daily and participates in the city marathon.

Author: Robin Gupta