Why 21 CFR part 11 is so important when using electronic documents


Technology has changed the way industries operated even a few years ago. More and more people are moving towards paperless operations as computer systems infiltrate deeper within the manufacturing sector. Maintaining and managing records electronically is gradually becoming the accepted norm for industries although it still has a far way to go before the dream of paperless industries and offices can become a reality. Regulated industries like pharmaceutical and life sciences use computer systems extensively in all spheres of manufacturing and administration like any other industries but have to take more responsibility to ensure that the systems adhere to the regulatory requirements. In this article, we will have a closer look at the regulatory requirements for electronic documents and try to understand its importance for life science and pharmaceutical industries.

The necessity for regulating electronics documents

There are always many concerns about the efficacy and authenticity of electronic documents and signatures that unlike manual documents are susceptible to malpractices. You can change electronic documents at will but would find it very difficult to do if you try to replace or manipulate handwritten documents and signatures. The vulnerability of electronic documents to forgery and manipulation has compelled FDA to impose rules and regulations that can ensure the authenticity of the electronic documents as well as the system used to generate it. These rules and regulations as spelled out in FDA 21 CFR part 11 have become the bible for Salesforce users in the pharmaceutical and life science industries.

Balancing it with GMP

The regulations of the Federal Food, Drug, and Cosmetic Act is intended at imposing close control on the manufacturing systems of medicines and allied goods destined for human consumption and use to introduce a uniform system of production labeled as Good Manufacturing Practices (GMP). When companies started using electronic documents and signatures, the FDA felt the need to formulate regulations that would ensure the use of electronic documents and systems in conformity to the same guidelines applicable to paper documents within the GMP framework. Thus, electronic signatures would become equivalent to hand written wet ink signatures.

Software that adheres to the best practices of the industry

The new set of guidelines is also applicable to software and systems used by the sector which is the reason why Salesforce 21 CFR part 11 is so important for its users in the pharmaceutical and life science industries. The Salesforce software has the necessary features and functions that aid in validating the system and process by the rules. Thus, Salesforce adheres to the requirements of the best practices of the industry.

The regulations have enabled life sciences and pharmaceutical industries to maintain a standard operating procedure for electronic documents that ensures high data security and data integrity through system validation. It has helped to eliminate the possibilities of human errors that were difficult to keep in check in the manual systems. This has resulted in lower operational costs, faster turnaround times and improved quality. Business processes are streamlined, and the compliance of the software gives the confidence of using the best system.

About the author:

Lucy Jones is a pharmaceutical industry expert who has helped several companies obtain FDA approvals. She works as a Consultant for a few companies including Flosum.com. Currently, she is busy preparing for the Great American eclipse that has become his obsession.

Leave A Reply