What You Must Know about Salesforce 21 CFR Part 11 - Make Money Online

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What You Must Know about Salesforce 21 CFR Part 11

If you are in the sector of Salesforce development, you are already aware of the all the latest offerings from the brand like Salesforce DX and Force.com. While the popularity of Salesforce is skyrocketing at the moment, many are left wondering if the platform is CFR compliant or not. Abiding by necessary regulations for building applications on Salesforce is important. 

What is 21 CFR Part 11?

Before understanding the requirements of the said regulation, there is the need to know what 21 CFR Part 11 is. Firms that need to use electronic records and electronic signatures for record keeping purposes of various types of information need to abide by Sales force 21 CFR part 11. The firms that range from different industries like handling and warehousing, manufacturing, distribution, drugs and medical devices and biologics must abide by the said regulation.

There is a need for computerized systems that deal with maintenance of electronic records to provide their customers with the assurance that:

      The information stored in the system is not only valid but also reproducible
      The party responsible for ensuring the entirety of records have done so
      Dates provided in the data cannot be altered
      The signatures on the documents are irrefutable representations of the legality of the records

Salesforce is compliant with the said regulation which means:

Salesforce holds its clients' security assurance among its priorities. That is why: 

      There is full record of to whom access is being granted
      Records of each login using unique login codes are used
      All signatures are unique
      Browser program is used for allowing access to the platform
      Computer platform is also used for access
      Records are also kept for API type and version in case the login is programmatically based

Things to note:

It is evident from the above discussion that Salesforce provides its customers with the highest level of security as far as data management, data reporting, and audit trail capabilities are concerned. All of its features comply with FDA 21 CFR Part 11 standards. 

The platform also enables its customers to regulate custom development of some specialized capabilities like electronic signatures, archiving and audit trail tracking. For this purpose development tools of Force.com can be used. Alternatively, these tools can also be acquired from many of Salesforce’s partners on AppExchange.

It is to be noted that customers are still responsible for the understanding of the platform, and for the proper configuration and management of the said platform. It is also the customers’ responsibility to ensure that the quality that the platform extends is in line with the IT policies and standards of their organizations. It is advisable to deployment is done in concert with a company’s own regulatory compliance policies.

Author bio: Lucy Jones is a journalist who likes to cover latest topics and various types of legal news. She is also a blogger who regularly publishes her write-ups on Flosum.com. In this article, she discusses the intricacies of Salesforce 21 CFR Part 11 and what it means for the platform’s customers.
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