Navigating the Path to Compliance

Sun Microsystems has developed a storage solution to support the life science industry's compliance requirements for long-term archival storage and electronic records management. Dynamic Data Management for Regulated Environments (DDM) provides an efficient, comprehensive, and cost-effective set of tools to meet the industry's specific needs.

In most businesses, paperwork is an inconvenience. In the life sciences, it's a way of life: A typical new drug or medical-device application routinely includes millions of pages, including clinical trial data, laboratory test reports, and other supporting documents.

Under the circumstances, it's not surprising that both the industry and government regulators are eager to implement fully electronic record-keeping systems. Since 1990, both sides have worked together to develop regulations to ensure electronic records and signatures provide the same security, certainty, and reliability as their paper equivalents. The most visible result of this process, known as CFR 21 Part 11, or simply Part 11, is that the FDA may never again have to receive a new drug application delivered in a semi truck.

Following the Right Trail

Yet the road to Part 11 compliance could quickly turn into a minefield for life sciences firms. Many legacy systems, for example, cannot generate an audit trail that's independent of the person who operates the system. A technician in that instance could repudiate test results that she previously approved—there's no way to ensure that it doesn't happen. In addition, many firms don't understand when an audit trail should start or what types of data it should include.

Sun Microsystems has developed a storage solution to support the life science industry's compliance requirements for long-term archival storage and electronic records management. Called Dynamic Data Management for Regulated Environments (DDM), the solution provides an efficient, comprehensive, and cost-effective set of tools to meet the industry's specific needs.

Yet the technology infrastructure provides only part of the solution to compliance challenges for life sciences firms. Firms must also decide exactly how Part 11 and other regulations apply to their own business and technology processes, and they will have to develop a strategy for designing, implementing, testing, and maintaining a compliant IT infrastructure.

Partnership Produces Results

Sun's partnership with BearingPoint provides one way to meet these challenges. BearingPoint (formerly KPMG Consulting) works with many of the world's leading life sciences organizations, including all four Fortune 100 pharmaceutical firms. BearingPoint's life sciences practice employs leading experts in regulatory compliance, change management, and IT systems validation and auditing procedures. In addition, as a Sun Partner, BearingPoint brings a decade of experience integrating Sun technologies for the two companies' life sciences customers.

According to Ed Tomlinson, managing director for BearingPoint's life sciences practice, the firm's clients must manage several key issues as they build compliant data management infrastructures. First, he notes, life sciences firms may lack the expertise or the resources to create an effective assessment plan for their compliance efforts. This includes identifying systems that may affect a firm's compliance, performing a gap analysis on those systems, and developing a strategy to close the gaps and validate a firm's technology compliance efforts.

"A large pharmaceutical or medical device firm may have anywhere from 3,000 to 5,000 systems that would have to comply with the (Part 11) regulation," says Tomlinson. Given the scale of these compliance efforts, he says, firms will also have to perform risk-based assessments to determine which systems are most likely to affect human health and safety, and to assign the highest priority to these systems.

The use of hybrid solutions, such as printing and signing electronic records, will also come under increased scrutiny as the FDA steps up its auditing and enforcement efforts. "The FDA is not eager to see firms using paper-based workarounds," says Tomlinson. "They want to see comprehensive electronic security and authentication measures that eliminate the need for any sort of physical documentation."

Overcoming a Legacy

Legacy systems present another especially difficult challenge. Although the FDA initially relaxed its decision that firms could not grandfather legacy applications into compliance, the agency appears to be moving back toward a more aggressive attitude. As a result, companies will have to decide which legacy systems are likely to affect their compliance efforts, whether to update or retire these systems, and how to migrate data from retired systems to newer, compliant data management solutions.

Once again, Tomlinson says, a rigorous assessment methodology, including a gap analysis, can give firms the information they require to make informed decisions about their legacy systems. Such an analysis will identify each system's strengths and weaknesses, prioritize systems based on their impact on a firm's manufacturing practices and Part 11 compliance, and work within the general context of a firm's regulatory compliance strategy. "This can be an extremely complex process. In addition to assessing the relationships between various systems, a firm will also have to decide exactly how to define Part 11 compliance for each system," says Tomlinson.

Finally, life sciences firms must develop an appropriate validation strategy as they implement compliant data management solutions. This process includes developing detailed scenarios, test cases, and standards for analyzing the validation results.

The result of designing a data management infrastructure specifically to meet the FDA's auditing and regulatory compliance requirements represents an important competitive advantage as life sciences firms attempt to take advantage of the cost savings and productivity a completely electronic record-keeping system can deliver. Yet for most firms, the important benefit may simply be the ability to avoid building systems that regulators will consider inadequate or incomplete.