Conformia's™ Life Sciences PPLM solutions targets Lab to Launch and provide science, business and regulatory benefits.

Conformia's™ Product Process Lifecycle Management Solutions ("PPLM") will enable multi-functional, cross matrix, global organizations to collaboratively manage and control their development process internally and with external partners.

Conformia PPLM solutions model and track operational data from six core DIMENSIONS (people, process, materials, equipment, environment, and standards) creating a digital record of development operations from Lab to Launch. Conformia PPLM Solutions organize information and knowledge into digital records(eDR).

The eDHR can then be analyzed, searched, audited, traced, stored, and aggregated over time and over any combination of the DIMENSIONS. Such functions enable"in-line" alerts, reviews (projects, phase-gates, decision points), and "in-process" snapshots, enabling crucial control over risk determination thereby supporting the FDA's Process Analytical Technology "PAT" approach. PPLM serves as the infrastructure for matrix driven operations in the form of Key Performance Indicators (KPI's) and dashboards.

The PPLM capabilities described above are applied throughout the lifecycle of drug substance and drug product development into scale-up for clinical trials, pilot manufacturing, product launch, and early full scale manufacturing. The relevant battery of quality tests, assays, and methods, in areas such as solubility, stability, safety and efficacy can be correlated to the stages drug substance / product development thereby optimizing manufacturing and quality testing.

Through the use of the DIMENSIONS, CONTEXT and Persistent Correlation™ inherent in PPLM, a company can more readily ensure that the right people using the right equipment, materials, processes, in the right environment adhering to their internal standards and complying with regulatory guidelines will succeed so that the right people can access the right information at the right time.

The PPLM solution can be used in multiple OPERATING MODES that reflect the changing conditions of the drug development phases. During the innovation phase of late discovery / early development,PPLM can focus on the electronic notebook knowledge management type of usage to simply capture essential information, organize it, and search for it. As Development proceeds into lead optimization and beyond, variability can be reduced by standardizing processes and methods for scale-up production.

Finally, as one nears regulatory submittal milestones and tech transfer to commercial manufacturing, information from the eDHR's can be managed through PPLM functions and fed into typical electronic document management systems (EDMS) and seamless transferred to manufacturing, saving time and improving the quality of the tech transfer.

Thus, PPLM enables a business performance focus on milestones, process improvements, and accelerating time to market balanced with a compliance focus on cGXP, PAT, IND/NDA/BLA in a manner that is commensurate with the level of development and required/desired level of control.

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Conformia™ has developed the worlds leading Enterprise Technology for Pharmaceutical R/D. We always strive to improve. Please feel free to email us suggestions or ideas.

For more information on the Life Sciences product release, functionality, scope and timeline, please contact Conformia™ at: LifeSciences@conformia.com