Understanding Validation and Data Security in The Context of Regulated Industries

LAGOS (Capital Markets in Africa) – Any software used in the controlled environment of the pharmaceutical, life sciences and healthcare industry and directly related to the manufacturing process must have validation done for acceptance by the regulatory authority of FDA. The concept of validation entails that there must be documentary evidence that the system is capable of producing consistent data related to a product that meets the quality attributes and pre-determined specifications. The Salesforce software is equipped to undergo the validation process and is the reason for its use in the regulated industries that come under the purview of Food and Drug Administration or FDA. Remember that Salesforce is not pre-validated but whoever wants it can get the Salesforce healthcare validation done. Since the scope of validation stretches much beyond the standard security systems built into the software, it is mandatory for these industries to use the validated software only.

Data protection is paramount
Data is useful only when you can share it. This basic concept thrived on technological advancement that enabled widespread data sharing. Data started flowing to every nook and corner, and it often reached unintended hands, thus raising the fears of data misuse. Financial services, healthcare and public sector industries and organizations, in particular, started suffering because of uncontrolled data distribution and it became apparent that there has to be some control over data to limit its access to specified people.  While information sharing is essential, you cannot share it with everybody. You must keep the data secured and segregated and distribute it to the designated persons who have to ensure its meaningful use. By keeping data secure, you prevent the misuse of sensitive data with the help of the built-in security systems of software.

Salesforce data security features
Salesforce has a robust data security system built into the platform so that users can maintain the sanctity of data by exercising complete control over it.  To protect data and allow its use in a regulated manner, Salesforce uses a two-factor authentication system and follows strict password policies to prevent any breach of the protective ring built for keeping data secure. All users enjoy a similar level of trust and confidence in the system that does not discriminate or overrule the defined levels of authority.  The system is completely transparent as users have access to login history, IP login restriction, fine grained sharing and audit trails for viewing the activities undertaken.

The added feature
Salesforce is popular in industries regulated by FDA because it has features that enable the software to become compliant with the rules and regulations mandated in 21 CFR part 11. It gives the regulators the assurance that the software can handle electronic data and electronic signatures in the way stipulated by the regulations of FDA. It signifies that the computer is capable of gathering complete and accurate information and electronic signatures are sacrosanct that cannot be repudiated.

The beauty of the software is that the audit trail of records from the time of its creation maintains the complete history of data and there is full accountability in data creation and alteration.

Author Bio:
Lucy Jones is a software developer with a specialized focus on the regulated industries. Starting his career with Flosum.com, she made rapid strides in floating his own company that he now heads. He regularly writes on topics related to his profession.