How Can Salesforce Help You Comply With Part 11?


Technology and healthcare are gradually becoming inseparable from all aspects. From delivering a cure to a life threatening disease to epidemiology management, technology is helping healthcare officials each day to collect data and organize it as actionable information too. Validation of codes and legislation in health care and research is another huge area where technology is actively involved.

Why use Salesforce for health care validation?

Flosum provides a flexible platform for Salesforce Dx tools to create applications that help companies, individuals, and huge corporations stay within the bounds of Part 11. That is the FDA instituted 21 CFR Part 11, which lays down the ground rules for all companies, organizations, and laboratories working with healthcare products and life sciences. Even clinical testing centers fall under the direct influence of the 21 CFR 11. Salesforce healthcare validation is thus critical for almost 60% of all companies in the USA (directly or indirectly). Non-compliance can lead to a hefty penalty or the cancellation of the license.

How does Salesforce ensure healthcare validation and Part 11 compliance?

Salesforce enables users to create tools and applications that can help companies comply with Part 11. Here are five easy examples, how –

  1. Electronic records: maintaining electronic files for almost everything from birth to flu shots has become a norm for all healthcare units across the country. Salesforce in collaboration with Flosum can give you the complete timeline of events, members involved and the revision history of the records updated.
  2. Validation of your system: this comes when you need to make a change to your end of the system application. The healthcare validation system will ensure that every change you make henceforth will meet the standards of quality and compliance for your team.
  3. Secure and time-stamped audit trials: audit and Salesforce are not your regular couple. Believe it or not, they are the power-couple of the computing world. Along with app development and record keeping, you can collect audit trails on a regular basis, automatically using Salesforce-driven applications. These audits will help you control and exercise the changes in your healthcare system.
  4. Electronic signatures: nothing is more important than electronic signatures as approvals of digital developmental processes. You will find Flosum in integration with E-signature solutions like DocuSign, live up to the necessities of digital document approvals. It will bring direct visibility and control to your development process.
  5. Increase visibility: using a linear software solution like Salesforce in coordination with Flosum, gives you an end-to-end solution. You can compare each of your developmental step against the 21 CFR Part 11, to stay on the right side of the FDA.

Cost management and streamlining all production procedures are surely other impetuses for all life sciences and healthcare based companies to adopt a Salesforce based auditing system.

Author Bio:

Lucy Jones is a software engineer, who has headed a number of projects at multiple MNCs over the last six years. Her work on is commendable, and it quite makes him the expert on application software compliance.