Enterprise resource planning (ERP) systems can benefit FDA-regulated companies but their complexity and regulatory challenges can derail a company’s efforts, says ERP expert Bill Fitch.
“The implementation of an ERP system is no easy undertaking,’” Fitch said. ERP is a business management system that integrates all facets of the business, including planning, manufacturing, quality control, sales, marketing, inventory control, order tracking, customer service, financial, and human resources. A well-architected project and implemented system can translate into better business process execution and integration of critical data across the enterprise, including improved erecord accuracy, reliability and security, said Fitch, life sciences vice president for Business & Decision (formerly Mi-Services).
But because of their widespread effect on a number of regulated business processes — including product development, manufacturing and processing, inventory, quality control and distribution — ERP systems “are usually the subject of scrutiny by various regulatory agencies, including the FDA,” Fitch noted.
Many ERP implementations fail to achieve a validated state the first time, according to Fitch, who said that the biggest hurdles facing FDA-regulated companies in attempting ERP are due to:
Accelerated or rapid implementation misconceptions: Software vendors and system integrators attempting to package their implementation services using these accelerated or rapid approaches, though attractive from a sales and marketing perspective, can be contradictory to the principles and practices of computer system validation. There is an inclination to implement standard out-of-the box business processes that may be noncompliant with the user-specific interpretation of the applicable regulations.
Inadequate planning for successful validation from the beginning: The foundation for successfully validating an ERP system is the development of a validation plan that is coupled with a documented and well-defined system development life cycle. “The plan should dictate a risk-based approach throughout, integrate the validation and implementation activities, and leverage the work product and deliverables of the implementation team,” he said.
Poorly captured and documented user requirements: Developing high-quality user requirements is acknowledged to be one of the most difficult tasks associated with the successful validation of any system. Without well-defined user requirements, it is extremely difficult to demonstrate that the system is fit-for-purpose, which is a point specifically addressed in regulatory guidance and the good automated maufacturing practice (GAMP) guide. A well-constructed user requirement should define requirements that are consistent, complete, realistic, individually stated so they can be individually tested, traceable to lower level requirements, measurable or objectively verifiable (testable) and fully specified.
Nonconforming IT infrastructure: “Over the past few years, FDA 483s relating to a failure to appropriately qualify IT infrastructure and the subsequent release of the GAMP guide on IT Infrastructure Control and Compliance would indicate the current trend suggesting organizations better qualify their GxP [good laboratory pracices, good clinical practices and good manufacturing practices] critical IT infrastructure,” Fitch said. “The good news is most organizations can leverage their efforts currently underway to meet the requirements of Section 404 of the Sarbanes Oxley Act,” he added.
Failure to maintain the system in a compliant manner throughout the operational life: Since the release of GAMP 4 there has been expanding focus on maintaining systems in a validated state once the ERP implementation and initial validation is completed, Fitch said. “This cradle-to-grave compliance practice is addressed in GAMP 4 and in other subsequent good practices guides,” he noted. — Michael Causey