Avoid Wasteful Fragmented Electronic Records Compliance Approach

FDA-regulated life sciences companies too often make the mistake of approaching erecords management in a fragmented manner that leaves them vulnerable to inspection problems and puts their products at risk, experts at Open Text told PIR last week.

“Companies really should consider a full assessment” in their erecord management programs, said Open Text’s Director of Life Sciences Solutions Nick Gilbert.

That fragmented approach is also wasteful, he added. “I’ve been to life sciences companies that had Chinese restaurant menus in their document control system.” An isolated incident may not be a problem, but too many unnecessary documents like that make it harder to find what you need when you need it, and that’s a sure way to irritate an FDA inspector.

It’s also a mistake to “ease off” 21 CFR Part 11 compliance efforts just because the FDA does not seem to be actively enforcing the rule at the moment, Gilbert said.

Something to consider: If the FDA decides it wants to shut down your company for practices it doesn’t like but is having a hard time clearly proving, it could use Part 11 noncompliance alone to shut your operation down, Gilbert pointed out. While not suggesting that FDA inspectors do that, Gilbert said his point was that failing to comply with Part 11 gives the FDA that capability.

Other common mistakes can undermine an erecords program, said Bill Forquer, Open Text executive vice president of Compliance Solutions Business. “Records management underpins compliance but even with its high-priority status, records management initiatives can get entangled in conflicting corporate agendas,” he said.

Open Text offers these erecords best practices:

Focus on business processes: Recognize that records management is a business process issue, not a technology issue. Understand how compliance can become a part of the way people work, not another job on top of their work. Work closely with your IT department, but be sure the business owners define the project charter and funding formula and sponsor the initiative.

Present the bigger return on investment picture: When looking for buy-in, define the benefits of the system not just in terms of cost savings, but also in terms of broader corporate compliance.

Don’t reinvent the wheel: Take advantage of existing records management work and expand it into the broader compliance landscape. A publicly traded company has already mapped out control points and standard operating procedures around internal controls and Sarbanes Oxley compliance. In doing so, the company has more than likely mapped out records management processes on some level, which offers a good starting point.

Align records management with your corporate ECM strategy: Consider your records management plan within your broader enterprise content management (ECM) strategy. How can records management rules be applied across email, images, web content, physical records and more? Knowing this helps identify which problems can be solved in the short, medium and long term, and what budget allocation is required.

Leverage existing IT systems: Your existing enterprise resource planning, customer relationship management and other systems contain all the data needed to describe corporate records. Leverage your existing investment in these applications and capture records metadata such as authors, contract numbers, employee IDs, customer numbers, case numbers and more.

Expect and plan for growth: Electronic information can grow at an astounding rate. Don’t design a records management system based on today’s volumes of information. Instead, develop a system that assumes significant growth over time.

Create a communication plan: Records management often spans many groups within an organization. Develop a communication plan that carefully outlines not just the appropriate level of awareness for each group, but also rolls out the appropriate level of technology change at various stages.

Make benefits clear to users: Be sure to show users the benefits of a records management system, such as better access to information and smoother business processes. If the system is seen as “more work” because of compliance burdens, user adoption will be slow.

Build in measures for success: How do you know that policies are being enforced? What will you do if they are not? And how do you plan to attest to the effectiveness of your system? Addressing these variables during the planning phase is critical to long-term, measurable success with records management.

Share best practices: Bring compliance, records and other managers together to share best practices and concerns to ensure a dynamic records management program. — Michael Causey