The persistence of elegantly crafted and refined paper templates and Excel spreadsheets to manage regulated documents and processes in the life sciences can in large part be attributed to a strong resistance to change, the lack of time, money, and a measurable ROI needed to assess and validate new solution approaches. At the same time, the increasing use of external partners is further complicating document and process management for regulatory and IT staff, with many key project and process managers increasingly residing outside of the organization and often thousands of miles away geographically. While it may have been possible in the past to walk across the hall in the past to collect a signature or determine the status of a submission, today's efforts routinely rely on less personal phone or email to track project status and hear about issues that may arise. As an additional concern, documents supporting regulatory compliance often reside across multiple systems, including email, separate document repositories, individual laptop/desktops, and manual filing systems. Beyond conversion to electronic versions of their historically paper documents and processes, electronic content management systems (CMS) are designed to capture supporting metadata that can add significant immediate value to regulated documents and processes.
Effective content management systems can also contain significant embedded intelligence by translating industry best practices into automated workflows that can be used to automatically identify omissions and discrepancies, highlight important deadlines, assess whether a submission is complete (and identify missing documents, if any), and enable extended use of data, information, and knowledge beyond the project at hand. From a regulatory compliance perspective, use of enterprise RIM solutions brings required documents into a single repository, facilitates more effective information access, sharing and review on a global basis, and simplifies responses to regulatory inquiries and audits.
While often presented as a more effective approach to managing and responding to regulatory audits, IDC has seen few cases where this was the primary driver for conversion from paper or an Excel spreadsheet to a CMS (or in this case, a RIM system). In most cases, additional benefits must be realized for investments to be made. Reduction and/or elimination of low value, repetitive activities at the operational level, improved process reuse for related efforts, improved compliance across partner organizations, and more real time monitoring and analyses of ongoing project efforts are regularly mentioned as key drivers of CMS implementations, with measurable ROI helping to justify investments to the C-suite. For RIM systems in particular, capturing and tracking of correspondence with regulatory authorities can come in multiple forms, including paper, email, and phone. While heavily time consuming to track retrospectively, systematic access to this information can better inform ongoing project efforts on a global basis, simplify compliance, and help to reduce the insanity of regulatory audit fire drills.
Regulatory information management (RIM) systems are helping regulatory organizations to work more efficiently and effectively. At an industry level, RIM solutions that reflect key industry (and company-specific) best practices are helping companies to maintain global compliance in an increasingly complex global ecosystem while freeing up remaining key staff to concentrate on more important concerns such as handling agency interactions rather than providing updates, status etc.. The ongoing and well advanced transition away from legacy solutions in the life sciences reflects the increasing maturity of commercial solution offerings and their ability to advance efforts that build on well-established industry best practices and bring enhanced levels of compliance and efficiency to key business processes.
Agree? As always, comments and differing opinions are welcomed.