Methodology - The Conformance Opportunity Assessment
Conformia Software has a different approach to our market and prospective customers than most other software companies. With staff backgrounds spanning management consulting, biotechnology and pharmaceutical operations as well as enterprise software, the company has successfully developed commercially available, off-the shelf software solutions to meet the specific needs of the process development environment and drive operational excellence. This includes achieving the following:

• Business Performance - align business processes with information management capabilities to enable superior operational performance and provide the tools necessary to measure the components of that performance
• Scientific Innovation - provide ability to leverage data in a manner that fosters continuous improvement and subsequently, a allows organizations to build greater understanding of the scale-up processes being developed
• Compliance Management - enable and facilitate mechanisms that ensure data is not only captured but also, preserves context as it moves from the non-GMP to the GMP operating modes; enforce business processes that have been defined to capture and communicate the information generated across these modes.

The factors influencing the operational performance and overall effectiveness of the drug development process can be hard to pinpoint. It is for this reason, that Conformia developed the COA - an approach that highlights inefficient processes by measuring them against best practice data obtained via Conformia’s initial market research studies of various pharmaceutical and biotechnology organizations.

Some of the specific information issues addressed in the COA:

• Measure organization's capacity to create a living "development thread" - one that allows users to understand the complete development history of a compound from bench to commercialization - correlate who, what, when, why, how, and where for each specific process step and decision
• Time spent searching for development data needed to assemble campaign summaries
• 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

Specific COA deliverables include:

Identify improvement opportunities as well as validate current best practices at the cross-functional level

• Provide management with both qualitative and quantitative data surrounding "current state" activities
• Offer suggestions for both systems and manual-based solutions needed to fill current gaps
• Measure alignment of business processes with information systems infrastructure
• Understand ability of IT systems to handle the needs and requirements of the PD environment (versus Commercial arena)

Lay foundation needed to design and implement a best-in-class "future state" drug development framework outlining steps to improved processes centered on business, compliance, and science; framework will be based on the following:

• Conformance Maturity Matrix* scorecard readout
• Interviews [intake sessions] across multiple levels and functions within process development
• Document review - includes business process guidelines, SOPS, metric scorecards, process descriptions, manufacturing procedures, etc.

In summary, the COA is a diagnostic tool that will help not only shed light on current operations within the PD/scale-up arena but also, provide the organization with the roadmap needed to help get more control of the information coming out of the process development organization.



If you have any questions on Conformia's approach or regarding how the COA and/or JDA might be applied within your organization, please contact:

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