PPLM Technology
Web based, enterprise class, standards based system.
PPLM Architecture
It is scalable and modular, and being designed to comply with 21 CFR 11 guidelines
Quality Control and Assurance
Conformia collaboratively builds its solutions with a "for the industry / with the industry" methodology based on a series of structured Conformance Practice Assessments (CPA) with our customers and development partners.
Key portions of our software development program are ISO 9001: 2000 certified. Engineering is striving towards extending the certification to the SEI CMM Level 5. Key portions are also being developed to meet 21 CFR 11.
PPLM complements EDMS
PPPLM enhances a company's Part 11 Electronic Document Management System / Common Technical Document, Validation, and Remediation programs by providing a consistent "source" system for submittals and audits. Companies that have extensive investment in EDMS would be able to leverage their existing investments with Conformia's PPLM.
PPLM as a Platform for achieving ICH Vision
Importantly, Conformia's architecture and underlying technology, when applied to the Life Sciences industry, supports ICH Q8/Q9/Q10 goals. PPLM is designed contemporaneously to enable systematic collection, storage, retrievable and reuse of key knowledge and understanding across the product and process lifecycle, collect multi-dimensional data at the foundation of PAT. Conformia's PPLM can deliver the integrated, enterprise-level platform upon which PAT, Design Space and Risk Management can be achieved.
If you have any questions about Conformia's solutions and how we can help your organization, please contact:
marketing@conformia.com
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