What is FDA 21 CFR Part 11?

FDA 21 CFR Part 11 regulation (Part 11) is the Food and Drug Administration's regulations that cover document signing and records retention for processes and documents specified by the FDA. Prescribed as an “open system” system solution, as defined in Section 11.3(b)(9), in which there is electronic communication among multiple persons and where system access extends to people who are not part of the organization that operates the system. The controls for an open system are discussed in Section 11.30.

According to IDC's 2015 report, The Document Disconnect, 76% of executives and managers in sales, HR, procurement, legal, and other departments estimate that fixing the “document disconnect” can lead to document process issues impact revenue recognition or create auditor issues. As process improvement experts, we at Praecipio Consulting love saving our clients money by mitigating wasted time and helping them do work faster. With that in mind, we've compiled our top 4 tips to get faster approvals leveraging DocuSign for Confluence to integrate your mission critical document tools. 

It’s natural for us to neglect maintenance. It works like this:

• You have a problem that needs to be fixed.
• You neglect the need for awhile because it’s not “bad enough” for you to spend money on it.
• The problem worsens; the need intensifies. Extra work is done to keep things running.
• The need is prioritized. But the solution is too expensive.
• The problem worsens even more. Tons of extra work is done to keep things running.
• The money spent on temporary solutions nears the total cost of a solution.
• You purchase a solution to the problem.

In our last Cloud post (Cloud Computing Risks and Rewards) we discussed a number of Cloud risks related to security:

• Data location (Do You Know What Your Data Is Doing When You’re Not Looking?)
• SAS70 and PCI Compliance
• Data protection (IDS, IPS, firewall, etc)