Understanding the aspect of regulatory compliance about Salesforce


Salesforce is a leader in innovative Customer Relationship Management (CRM) software that has 150,000 customers worldwide until May 2016 and still counting. Taking advantage of Cloud computing, the Salesforce CRM platform hosted in the Cloud proved much superior over legacy CRM platforms that took much longer time to convert ideas into usable apps. Salesforce does away with the need of building tools and infrastructure by yourself as you can make use of the tools provided on the platform to build your app.  Being very user-friendly, Salesforce is easy to deploy, and its ability for customization to meet the needs of any business are the reasons for its popularity.

The need for special features

The versatile platform finds a broad application across all kinds of industries including pharma, healthcare, and life sciences. The use of the software platform in the health care and life sciences sector needs a special mention because the platform has all the necessary features to make it suitable for use in that particular industry segment.  Unlike other areas, the pharmaceutical, health care, and life sciences industries are governed by FDA regulations, and Salesforce 21 CFR part 11 are unique features added to the software that enables compliance with the regulatory requirements. In this article, we will discuss what this compliance means and why it is necessary.

Compliance with industry protocol

The general FDA regulations that bind pharmaceutical, health care and life sciences industries revolve around two fundamental parameters – qualification of systems and its validation. The process of qualification relates to the evaluation of a system to confirm its compliance with conditions, specifications, and regulations perceived and imposed at the beginning of the development process. In the validation process, the evidence is collected to provide complete assurance that the system is capable of accomplishing the tasks it is intended to perform.  This protocol is also applicable to any software used in the industry that has direct interface with the manufacturing process at any stage.

Significance of 21 CFR part 11

Pharmaceutical, health care and life sciences companies intending to make use of electronic documents together with electronic signatures must comply with the guidelines outlined in 21 CFR part 11which is a part of the Code of Federal Regulations that provides the platform for implementing the law specified in the Federal Food, Drug, and Cosmetic Act.  The law applies to the computer systems that come under the purview of existing FDA regulations.

Validation is must

Since it is mandatory for companies to meet the regulatory requirements, the computer systems they use must have features and technical capabilities that allow the companies to meet the requirements set by FDA. Besides confirming that the systems are compliant, companies using it are also responsible for determining that the process to remains compliant with the regulations. This has to be done by looking into the aspects of deployment and configuration, the purpose of using the system and other processes and procedures that support the application.

Salesforce has all the features and functions that can help to get the system and process validated.

About the author:

Lucy Jones is a software engineer with experience in development of enterprise solutions. She has authored an e-book on Cloud computing and SaaS. Having worked will various types of industries including Flosum.com, she uses his experience to create awareness about Cloud computing.