Part 11 Moves the Focus of Regulatory Compliance Beyond the Manufacturing Operation, By Roddy Martin, AMR Research
However, Part 11 is not limited to validated cGMP operations, it addresses the management and control of e-Records as they gradually replace paper based systems and NDA submissions. The issue is that the elimination of paper records and the transition to e-Records is a key component of the global regulatory compliance management strategy and a foundational requirement for E-Business. In a research report written last year AMR Research established that over 40% of the IT budget is being spent on regulatory compliance because of the fragmented approach being taken to compliance efforts across the business. This disconnected, tactical approach to regulation projects is due to functional silos and the lack of an overarching compliance management strategy. IT systems are validated in isolation of each other, resulting in disconnects in business processes and resulting business inefficiency. A fragmented approach to achieving Part 11 compliance will simply aggravate that position.
Increased Move to e-records
While the FDA is not forcing companies to move to e-Records, there is a move amongst manufacturers towards the elimination of paper and the increased use of IT systems to improve productivity and knowledge management across the business. For example in the case of electronic submissions, the FDA reports that there has been a steady increase in the number of electronic submissions received. The FDA has been receiving Case Report Forms and Case Report Tabulations in electronic format since Part 11 was implemented in November of 1997. Since February of 1999, the FDA has been able to receive the entire archival copy of the NDA in electronic format without paper. In the last year they received over 500 submissions and over the past few months have been averaging over 100 per month. Currently, about 75% of the original NDA's are submitted with at least a portion in electronic format and about 35% are completely electronic. Almost all of the larger pharmaceutical companies and many of the smaller ones have sent in at least one submission with an electronic component.
In terms of Part 11, e-Records pertaining to clinical trial data, electronic drug approval submissions, records of environmental conditions relating to a batch of product in transit, and even e-Records of promotional products issued to patients by physicians are covered by the requirements of Part 11. The focus of compliance has moved to the extended supply chain and is no longer just a manufacturing IT issue.
The reality is that manufacturers are still using paper-based record keeping and clinical trial data management systems. The number is estimated to be as high as 95% paper based. The move to e-Record management systems has been slow partly because the Life Sciences industry is littered with home-grown systems, fragmented IT architectures, and older software products that are no longer supported. It is difficult to make the change without introducing unwanted risks into the business. The challenge is that in Part 11 the lack of a grand fathering clause means that even legacy systems must be fixed.
Part 11 Analogous to Y2K
In recent research study conducted by AMR Research reveals that manufacturers anticipate that Part 11 rectification are between $100M and $250M per company. Some manufacturers are indicating that Part 11 rectification has greater cost implications than Y2K. However, Part 11 urgency has not reached the executive business ranks and in many cases is being left to the Regulatory Affairs and IT groups to resolve. The difference between Y2K rectification and Part 11 compliance is that the scope for Y2K rectification was clear. Y2K required that businesses find, check, and correct all software based date fields before the switch over to 2000. Software tools were built to automate this task. In the case of Y2K it was easier for the business executive for assess the business risk and prioritize the allocation of business resources. With Part 11, the challenge for the business executive to get their arms around quantifying the problem and assessing business risk is much greater. After all, their perspective is that manufacturing sensitive IT systems and procedures have been validated at great cost and are operational. The perspective is that like Y2K, consultant and software vendor driven hype is aimed at increasing revenues. Rectification seems like it will simply contribute more non-value adding costs to the business. The problem is that there is still a perception amongst business executives and some software vendors that a validated cGMP system is Part 11 compliant. Which, as we know, and the FDA is adamant about, is not the case.
Part 11 is not just a Manufacturing Issue
Part of the problem is that the issue is still largely seen as a manufacturing issue. The newly appointed Head of Regulatory Affairs in leading manufacturing companies, who is in many cases ex-FDA, does not have the business process and supply chain experience and expertise to be an influential executive force for change across the extended business.
The current status is that in most cases companies are still forming teams and processes to assess the scope of Part 11 rectification work, interpret the FDA's guideline requirements, and put together an inventory of systems that must be rectified. The harsh reality is that warning letters for Part 11 violations have already been issued to manufacturing companies. The FDA has moved from developing the standard to enforcing it!
Leading manufacturers are taking the smart approach that the problem is not just an IT one. The strategy is that Part 11 rectification can be used as the foundation of a joint business and IT initiative to improve productivity of business processes and performance. Part 11 introduces the opportunity to increase the use of IT to enhance business performance, for example moving from paper to e-Records. These leading companies are using the Part 11 opportunity to streamline business processes, prioritize integration projects, institute an e-Record management architecture, and build change management governance across the organization to sustain compliance. They are seeing this as the ideal burning platform to create a formal foundation for E-Business based cross-functional integration of processes and e-Records across the supply chain. However, this approach requires a coordinated, global, top down Compliance Management Strategy that puts in place an enterprise wide plan and drives policies, guidelines, standards, procedures, and rectification priorities down to the appropriate level for execution.
However, all is not lost in the Part 11 rectification of legacy systems! The emergence of Part 11 enabling software applications from leading vendors such as QUMAS, Doxis, and Documentum allow Part 11 compliant wrappers to be implemented around existing systems and records. These applications facilitate the management of security, authenticity, identity, audit trail, change management, integrity, and security of e-Records across diverse applications that may not be Part 11 compliant. In the case of data repositories, NuGenesis provides an application that archives data from applications in a Part 11 compliant repository.
Use part 11 To Drive Continuos Improvement
The message and opportunities are clear. Assign business executive sponsorship for Part 11 education and rectification, and reinforce the issue that Part11 is a business and IT responsibility. Use adapted learnings, processes, and methodologies from the Y2K initiative to bootstrap the Part 11 compliance program. Use the rectification opportunity wisely to define a coordinated 2-3 year plan to streamline and improve productivity in business processes across the extended supply chain. Implement an e-Record management architecture that entrenches Part 11 governance and lays the foundation for E-Business technology using the web. Don'st rectify IT systems in isolation across the business, look for common solutions that can be leveraged across multiple rectification initiatives to reduce the number of once-off fixes and lower rectification costs. Use the Part 11 opportunity to drive towards minimizing the number of core IT platforms and vendors. When in doubt, access the FDA, they have offered to help manufacturers and vendors interpret the requirements.
The reality is that Part 11 will be an added resource and cost burden to the business, it's the degree to which that is true that is different. Every dark cloud has a silver lining; Part 11 could be the opportunity to fuse business and IT initiatives and build sustainable compliance governance combined with business process productivity. There may not be such another good IT harmonization opportunity soon!