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ACE Case Study
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Overview
Managing the knowledge accumulated across the Product and Process Lifecycle (PPLM or PLM) presents significant opportunities for the Pharmaceutical R/D and other Process industries who are dealing with a multitude of complex business, science and regulatory compliance challenges. Today’s dynamic process industry business environments are characterized by global teams, in different locations, performing mission critical work with a combination of in-house and outsourced staff. Today it is difficult to put the “Right information, in the hands of the Right People, at the right time.” Regulatory pressures are also increasing with the acceptance of ICH guidelines Q8/Q9 and now Q10, knowledge management is seen as a critical enabler of achieving Quality by Design.Achieving goals for pharmaceutical development in the 21st century means changing the CMC paradigms by relying on more robust process understanding, PAT, Risk Assessment, Design Space and ultimately filing a more “knowledge rich submission.” Failure to take action and begin implementing processes and systems will put companies behind the curve. Those that do respond aggressively will gain tremendously.
The foundation of Conformia's technology is the powerful Development Operations (DEVOPS) Platform which provides core elements such as a robust integration platform, service-oriented architecture, alerts, workflows, and audit trails to make product development efficient, scientific innovations more attainable and compliance proactive. Conformia’s Product Process Life Cycle Management (PPLM) provides core application software modules to track, trace, and improve the core dimensions of process manufacturing: people, process, equipment, materials, environment/facilities and standards.
Conformia Software is the leading provider of product and process lifecycle management solutions to Life Sciences and other process manufacturing organizations.
Conformia PPLM enables simultaneous benefits to companies:
The foundation of Conformia's technology is the powerful Development Operations Platform built on JAVA/J2EE, Services Oriented Architecture(SOA) and leveraging Enterprise 2.0. Conformia DevOps platform provides a robust integration platform, modern security, role based configurations, alerts, workflows and audit trails to make product and process development efficient, scaleable and global.
Conformia’s family of application suites are based on core reusable enterprise software modules that span the lifecycle of Pharmaceutical Development from “Lab to Launch”. One major step in implementing global knowledge management is being able to organize all the key prior and ongoing knowledge in systematic reusable ways. Conformia provides a core family of applications that are all enterprise library based to support these goals:
Equipment Module
Materials Module
Process Module
Environment Module
Standards Module
Conformia’s patented technology provides seamless support across the entire product / process lifecycle for Chemical Development, Pharmaceutical Development, and BioProcess development. Conformia PPLM supports experiment rich environments with the Conformia enterprise electronic lab notebooks (eeLN); a seamless transition to pilot plant scale up and management, the production of clinical supply and the transfer to commercial manufacturing.
“Conformia’s has an amazing approach to electronic batch records (eBR), Clinical Supply Chain Leader, Top Pharmaceutical company"
“We trust Conformia to bring us the latest technologies and solve our biggest challenges” Leading Pharma Company, Strategic Operations Conformia's PCM Platform and application modules can be used as standalone solutions or in concert with existing systems such as LIMS, eLN, EDMS, MES and SAP's full business suite for Commercial Manufacturing, R&D Admin, Clinical Trial Supply Management, XMII as well as the SAP Netweaver Platform.
History
Conformia was established in July 2000, to develop solutions that would enable regulated process oriented industries such as Life Sciences (Pharmaceutical and Biotech), Beverage Alcohol (Wine, Beer, Spirits, RTD's), Chemicals, Agrichemicals, Food, Dairy, Poultry/Meat, Cosmetics, Nutraceuticals, Oil and Gas. These types of regulated process manufacturers consistently face new challenges in complex production, product innovation and compliance. So far, the Company has focused on the first two process industries for its solution: life sciences and beverage alcohol.