The Implications of Validation Ready Software and Its Importance from The FDA Perspective

by ​Sujain Thomas, Guest Contributor

​Regulated industries like pharmaceuticals, healthcare, and life sciences have to comply with the guidelines of Food and Drugs Administration (FDA) that stipulate the use of appropriate software that meets the regulatory requirements of FDA. Being the leader in Customer Relationship Management software (CRM), Salesforce is an FDA approved software because although it is not validated software, it is validation ready. Anyone who wants to use the Salesforce platform of software for the FDA regulated industries can do it with confidence but have to get the validation done. The platform comes with special features that make it compliant with 21 CFR Part 11, the FDA guidelines that define the regulatory requirements that organizations have to comply when using computers and software for their operations.

Validation Ready Software and Its Importance

Validation is an essential aspect of regulated industries for ensuring data integrity and data safety so that data remains authentic.Although Salesforce has enough security features and you can even add more to it, meeting the FDA requirement is mandatory.  Since data integrity and data security have close links, in this article, we will explore how Salesforce ensures data security for users.

Data security is the responsibility of organizations
While the Salesforce platform ensures that data remain safe and secure, users have to take full responsibility to maintain data securely. They have to take adequate measures to ensure that business data, especially the sensitive ones, do not find its way into the wrong hands. While data is helpful for spreading information, there must be suitable controls in the system so that there is no misuse of data. Those in the healthcare industry, financial sector, and public sector have to ensure that the right data reaches the right people only by following the FDA guidelines that help to exercise complete control on data to keep it safe and secure. Companies like Flosum.com can assist in Salesforce compliance, governance and security.

Salesforce meets FDA guidelines
The features of Salesforce take into account the FDA guidelines so that it becomes easy for users to validate the software according to the needs of the organization. Salesforce fulfills the requirements that are special for the regulated industries like pharma, life sciences, and healthcare. For using computer systems in a controlled environment, it is necessary to get the software validated according to the regulations stipulated in 21 CFR Part 11, a set of instructions issued by FDA. Salesforce is just the software that the regulated industry needs to prove their good intentions of following the FDA guidelines.

Salesforce is secure and trustworthy
The stamp of 21 CFR Part 11 is a mark of the trustworthiness of the Salesforce platform and software, most preferred by the industries under the control of FDA. Password policies form the first line of defense in data security that ensures only authorized persons can access the data. Additional protection in the form of two-factor authentication creates a strong safety net.
Salesforce brings complete transparency to the system by ensuring that all activities undertaken remain visible with a full audit trail.
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Author Bio: 

​Sujain Thomas is a data expert. She has been working with complex database architecture and big data analytics for almost eight years now. She has been helping many leading corporations optimize their customer service and product introductions as per big data analysis and predictive analysis.

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