Pharma Eyes PLM For Enterprise-Level Information To Handle FDA Compliance, PAT/QbD, Clinical Trials
By Peter A. Bilello, President, CIMdata Inc.
It may be impossible to find an industry facing more product development challenges than pharmaceuticals, not even oil and gas or nuclear power. In addition to the profitability, manpower, and sustainability issues that confront every enterprise, “pharma” managers wrestle daily with intense regulatory scrutiny, direct regulator involvement in operations, clinical trials, and long and costly development cycles.
These business challenges present pharma with a huge opportunity to benefit from Product Lifecycle Management (PLM) strategies. PLM brings together people, processes, and technologies to manage the intellectual property of the enterprise regardless of how the information is generated, by whom, and from which processes and operations. FDA regulations aside, good management of data and information flows is a powerful business driver for investing in PLM. Adapting them to operate amid the data tsunami at the enterprise level, as PLM does, offers huge potential gains.