Electronic documents acquire particular significance in the industries regulated by the Food and Drug Administration (FDA) because the software must comply with some special requirements that are part of the regulatory needs. Although computers are for industries across all sectors, you must take special care when using it in the pharma, life sciences of healthcare industries that come under the purview of FDA. Since FDA regulates the manufacturing process, it is natural that the computer systems and software that support it must be qualified similarly. It means that the software that you use must have features and capabilities that allow its validation in conformity with the guidelines set by FDA. Using Salesforce 21 CFR part 11 compliant software is thus the norm in these industries as it is capable of meeting the regulatory requirements. Read on to know more about it.
The need for control
The problem with electronic documents and signatures is that it is prone to manipulation just in the way you can morph photos and images or juxtapose text. It is easy to play around with electronic records, which raises doubts about its authenticity. The vulnerability of electronic documents makes it necessary to impose strict regulations on its use so that there are no possibilities of tampering with it. To make electronic records including electronic signatures safe for use in the regulated industry, FDA has introduced CFR 21 part 11, a set of guidelines that every industry must follow. Adhering to the guidelines ensure that the electronic documents are authentic.
Why CFR21 part 11?
The pharma and other regulated industries governed by FDA have to follow Good Manufacturing Practices (GMP) that ensure close control of the manufacturing systems for medicines and other items meant for consumption by humans. Companies that follow GMP adhere to a uniform standard of manufacturing. When the regulated industries started using electronic documents and electronic signatures, FDA felt the need to follow similar guidelines for the unification of standards so that all sectors follow the same. The philosophy of GMP, especially the concept of qualification and validation is encapsulated in 21 CFR part 11, which is the bible for using electronic documents in the regulated industries.
Compliant software is part of best practices
The use of software or software platform like Salesforce, which is compliant with FDA guidelines automatically ensures that you are adhering to the best practices of the industry. The software has features that enable its validation in conformity to the FDA guidelines. It bears the hallmark of the most reliable software for pharma, healthcare, and life sciences industries.
According to the regulations, electronic documentation is governed by standard operating procedures that outline every detail about document generation and control as well as retrieval and retention of records. There is an explicit mention of the steps that you have to take for data security and data integrity that would ensure that there is no human error. The result is a streamlined business process that is capable of delivering high-quality products.
Author Bio: Sujain Thomas is an FDA inspector. She is a postgraduate in pharmaceutical science and is a software specialist in the industry. Companies like Flosum.com often turn to him for consultations. She loves to travel and keeps trotting across the globe.