No matter what software or system is used, the key to making document management successful is deploying systems and processes concurrently. Because a document management system directly affects how people do their work, that work may have to be restructured to take advantage of the efficiencies offered by such a system. To capture maximum value from document-management systems, companies must examine their operating systems and approaches, break down work processes, and reconstruct them in a manner that:

• capitalizes on benchmarking and best practices research
• better uses budgeted regulatory and QA funds
• identifies compliance "high-risk elements"
• standardizes outsourcing
• eliminates redundancies in the QA and regulatory environment
• reduces document-review time
• forges tighter links among work units
• minimizes modification of the chosen system.

Successful document management, thus, does not require a computer system as much as it requires a computer-related system. Whereas the former involves implementing hardware, software, and peripherals, in the latter a comprehensive operating environment is implemented that also includes system inputs, related business processes, operating procedures, physical utilities that support system operation, and any other factors that affect the "steady state" of the system.

Integrated document-management systems are needed to produce the strong SOPs, training, and auditing programs, system security, and disaster recovery documentation that increase compliance.

Regulatory oversight is a fact of life. Companies do not have the luxury to decide which mandates they find applicable or practical. But they do, in most cases, possess the opportunity to become more strategic about how they meet compliance requirements. For all that they currently do—or fail to do—to manage compliance, companies must understand that savings in time, cost, and aggravation are achievable. Ascending to a strategically focused culture of quality that emphasizes business objectives, improved communication, risk management, and the informed application of technology will improve processes as well as products.

But beyond all the methods and technology for moving from reactive compliance to strategic quality management lies the most important factor of all—people. Processes and products in biotech are intricate and expensive; the risk of failure is high and the consequences are huge. The performance of people and the tools that are available to them in this environment are therefore critical. Generally speaking, most FDA citations appear technical. But their root cause is nearly always managerial issues that impede the performance of people: Is the right information reaching the right people on time? Are personnel properly trained? Is the company leveraging available information to improve operating practices? Are regulations being interpreted properly and, once interpreted, are they being translated into applicable SOPs? A strategic quality management program that empowers people to move beyond mere compliance is not only economically justifiable but will be welcomed throughout the organization.

Michael M. Breggar is a principal at Tunnell Consulting, King of Prussia, PA, 610.337.0820, breggar@tunnellconsulting.com