Steve Gens' new series of blogs are based on the Annual RIM Whitepaper 2016 Summer Edition. In the Part 2, he compares RIM operating models.
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For years, RIM software vendors have talked about the importance of having a common platform or suite of products for successful management of regulatory information. For industry, a “common” capability requires much more than a set of tools. It requires common processes across sites and geographies, standardized data definitions and entry criteria for the information captured within the RIM systems, as well as enforcement of those standards.
A key question in this survey was whether respondents had a common RIM capability for their products or not. Of the 54 companies that responded to the survey, 56% had a common capability for all or most of their products, and 44% had disparate (or separate) capabilities for their products. However, 80% of those with disparate capabilities were in the planning stage to converge their RIM capabilities. In terms of RIM programs, the industry has been in a state of transition for a few years and it appears this phase will continue for several more.
Those companies that have achieved a common RIM capability have spent significant effort aligning their business to support their RIM program. They have focused on establishing a global organizational structure, creating a governance structure with clear definition of roles and responsibilities, documenting end-2-end process ownership, and creating formal data standards with milestones related to the timely entry of regulatory information.
These efforts have resulted in a significant realization of business benefits and value compared to their counterparts with disparate RIM capabilities. In 9 of the 12 identified program benefit categories, those with a common capability were at least 3 times more likely to have realized the benefit, and at least 2 times more likely in the remaining 3 categories (range 2-9; see Exhibit 8). The largest gains are related to increases in user productivity, reductions in time to submission, reductions in operating costs and better business process integration.
In addition to realizing business benefits, those with a common capability were on average, 18% more efficient than their disparate capability counterparts. The largest efficiency gains between models were seen in Management of Product Registration Data (31%), Submission Document Management (25%), Dossier Management (23%), Submission Production (20% more efficient), Management of Health Authority Commitments (18%), and Management of the Regulatory Archive (17%). Disparate capability companies tended to have a higher efficiency in areas related to interactions with other departments such as, Legal Touch Point (15%), Manufacturing Change Control Touch Point (13%), and Supply Chain Touch Point (10%).
One of the most important aspects of any RIM program is to ensure that the time and effort expended in capturing the information results in accurate information being available quickly to assist in decision making. There is little value in capturing information just for the sake of capturing it. Users of the information must have confidence in what is provided by the systems without the need to “check” its accuracy with other parts of the organization. Worse yet is maintaining an alternate source of data, such as a spreadsheet. Once again, companies with a common capability performed equal to or better in all categories than their disparate capability counterparts. Common capability companies were six times more likely to have confidence in their data related to 2 key regulatory compliance areas -Meeting Health Authority Compliance Reporting and Open Health Authority Commitments (see Exhibit 9).
In addition to having confidence in the data, the organization must be able to access the data quickly for business purposes such as determining the impact of potential product recall or at the request of an inspector to aid in business decision making. This critical data is twice as likely to be available in a matter of hours to a company that employs a common RIM capability (see Exhibit 10).
Industry believes that a common capability is a benefit to their business and this survey confirms this belief. Next week, in the Part 3 of these blog series, we will have a look into applying emerging technologies in the RIM space.
About the author
Steve has over 25 years of experience, primarily in the biopharmaceutical and healthcare industries. After leading many technology and business process initiatives for Waterford Crystal and Johnson and Johnson, he developed an interest in global teams and organizational performance. He moved into consulting where he built and managed several healthcare consulting practices for First Consulting Group and Booz Allen Hamilton. Steve has deep strategy formulation, organization development and performance, global workplace collaboration, industry benchmarking and information management strategy expertise. Steve holds a Bachelor of Science degree in Business Computer Science and a Master of Science in Organization Development with distinction for his field work from American University. He is certified in Change Management from the NTL Institute of Applied Behavior and is a frequent speaker with several publications.