It’s no secret that FDA regulated industries are motivated to find better ways to comply with ever-increasing government regulations and formative industry standards. GMP requirements, 21 CFR Part 11, Sarbanes-Oxley, HACCP and other regulations have made compliance- and risk-management a key concern for any regulated organization.
Explore this issueFebruary/March 2006
Many companies have already been cited for their failure to achieve compliance As a result, in addition to encountering expensive product recalls, negative publicity and loss of market capitalization, they have faced regulatory scrutiny, manufacturing facility shut downs, product approval delays and considerable fines.
Managing GxP compliance-related events and actions including deviations, audits, observations, change controls, complaints, corrective and preventive actions and other regulatory processes, requires both formal procedures and effective processes to ensure closure. In addition to quality initiatives, companies need to manage environmental issues and actions, employee health and safety incidents and investigations, Sarbanes-Oxley risk areas, clinical trial compliance issues and other regulatory accountabilities. Managing all of these processes, compounded with the additional corporate responsibility of compliance with internal policies and procedures related to privacy, human resources, tariffs and others, results in what appears to be an almost insurmountable challenge.
Challenges to Overcome
Control of these processes is essential, as even a single misstep can lead to fines, law suits and expensive contract remediation.
The common denominator among all of these compliance processes is the need to manage and track related events and actions from start to completion. Documenting, tracking and trending processes that carry such a high risk cannot be accomplished using paper-based systems, or disconnected and rudimentary electronic solutions. Regulatory agencies, including the FDA, have set forth objectives to aggressively and continually modernize regulation procedures for their respective industries, as noted in the agency’s Second Progress Report and Implementation Plan (September 2003), and expect companies to do the same by utilizing robust systems with powerful functionality including data validation, process automation, integrated reporting and elaborate security.
These requirements have plagued pharmaceutical and device manufacturers for many years, and now food and chemical API manufacturers have joined the ranks of those challenged with finding and implementing software solutions to which they can trust their most risk-sensitive data. Last November, the FDA modernized food GMPs, and EPA, which strictly regulates all manufacturing industries, continues its ever-increasing focus on risk-based compliance monitoring for environmental and public safety through its Statutory Compliance Monitoring programs.
Now more than ever, manufacturers in all of these industries are proactively searching for solutions to manage regulatory compliance. Three main challenges present themselves: 1) Finding robust and flexible systems which can support both compliance and business needs; 2) integrating the plethora of compliance related processes at hand; and 3) implementing these systems in an expeditious and cost effective manner.
Even more daunting than addressing known compliance needs is the looming threat of additional compliance requirements in the years to come.
The answer lies in what is termed an “enterprise compliance management platform.”
It is important to appreciate that an enterprise compliance management platform is not a myriad of separate software programs organized as silos of information. Traditionally, companies have been responding to compliance needs by implementing separate point solutions or individual software modules. While various tools exist for different compliance needs, a strategic platform provides an organization the ability to address and integrate any possible compliance process as part of its inherent architecture.
Many of the larger pharmaceutical companies have already realized that there are numerous advantages to standardizing the management of compliance issues onto a common software platform. A standardized platform provides the necessary ability to integrate data, workflow and reporting without costly customization and validation effort. Further, by implementing one system rather than many, organizations can significantly reduce the cost of licenses, hardware, validation, training and maintenance.