Conformance Maturity Matrix (CMM): Measuring Conformance Performance Across Best Practices in the Biotech/Pharmaceutical Industries

Conformia developed the Conformance Maturity Matrix (CMM) to identify key factors instrumental to achieving best practice performance in "Conformance Management" - the ability to capture, store, and communicate information across the complete lifecycle of development in an manner that enables businesses to simultaneously improve scientific innovation, business performance, and compliance goals.

Based on extensive market research in the pharmaceutical and biotechnology industries, the CMM allows companies to compare their current processes against best practice techniques identified to drive and create operational breakthrough performance across information management and integration.

The CMM's foundation revolves around three elements responsible for optimal development management:

• Business Performance - align business processes with information management capabilities to enable superior operational performance
• Scientific Innovation - ability to leverage data in a manner that fosters continuous improvement and a greater understanding of the scale-up processes being developed
• Compliance Management - enable and facilitate mechanisms that ensure data is not only captured but also, enforced as processes move between non-GMP and GMP operating modes

Using these as the core elements, the CMM break outs 37 associated attributes (sample attributes listed below) that pinpoint gaps across the following categories:

Governance Decision-Making Prioritization Business Initiatives

Visibility Storage Retrievability Accessibility Leverageability

Information Systems Business Processes Tech Transfers Change Management Planning & Execution Partner Management Quality Systems

Cycle Times Quality Time to Market Project Performance Enforce Business Processes

The CMM assessment quickly identifies the specific strengths as well as areas for improvement across the different areas making up the conformance management in the development arena. More importantly, the results serve as a roadmap for best practices that pharmaceutical and biotechnology executives can use to achieve the efficiencies and overall performance needed to stay competitive in today's pharmaceutical industry.


Approach and Sample Output

Issues:
A multi-billion dollar, multi-site life science organization was faced with a number of delays associated with its process development and scale-up activities. Faced with increasing productivity-related demands, the process development group asked Conformia to apply its CMM technique across the business, science, and compliance processes supporting the organization to help it identify solutions for improving quality, capacity, and overall productivity.

Approach:
Coupled with information gained from primary interviews, Conformia distributed the CMM survey to over 50 individuals spanning various functional groups and levels at multiple sites involved in process development activities. The survey was also distributed to key members of the company's contract manufacturer involved with the early to late stage development activities.

Results:
After compiling the results of the survey, Conformia identified the key gaps responsible for the company's limited operational performance. Revolving around poor cross-functional communication, approach to data capture, and siloed information systems, the company was not able to establish an effective technology transfer process. Indeed, requirements needed to transfer a process from one stage to the next were established "on the fly" in an ad-hoc manner. This approach further deepened the silo mentality observed across different functional groups - making it increasingly difficult for the downstream functions to know what to expect from their upstream partners.

Using the CMM results as a guide, Conformia worked with executives to design a roadmap not only presented the solutions but also, how this "future state" could be achieved by taking advantage of the organization's current best practice qualities.

Scorecard Examples:

• Measure organization's capacity to create a living 'development thread' - one that allows users to understand the who, what, when, why, how, and where for each specific process step and decision taken
• Ability to gather relevant data for reports, campaign summaries, investigations, etc., in a timely manner
• Gauge effectiveness of current information systems and their ability to organize and "structure" data generated during the process development stage
• Ability to compare planned versus executed processes within the batch record; correlate batch record with associated planned process descriptions and associated material, equipment, etc. used
• Continuous improvement - tools that allow data from past experiments to be leveraged in a manner that fosters process understanding
• Understand organization's ability to communicate information at the cross-functionally as well as across the enterprise; ensure that information needed to make key decisions is available at the right time and place (i.e. technology transfer reviews, phase-gate reviews, portfolio decisions, etc.)
• Determine the value proposition available to the organization by improving Product Conformance Management

If you have any questions regarding Conformia's approach and how your organization might benefit from participating in a CMM study, please contact:

Anjali Kataria, Co-Founder & Chief Marketing Officer
by email: akataria@conformia.com