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ACE Case Study
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Find out how your organization can benefit from Conformia PPLM Solutions now! read more >> |
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Conformance Opportunity Assessment (COA) read more >> |
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Conformia collaborates with the FDA under a Cooperative Research and Development Agreement (CRADA) read more >> |
Challenges across Pharmaceutical R/D
The process development and clinical manufacturing stages of pharmaceutical and biotech drug development are incredibly complex. Multi-site global development teams, outsourcing, joint ventures, mergers and acquisitions, combined with process development and scale-up considerations have produced a challenging development environment where people, process, equipment, materials, facilities and standards remain isolated by islands of expertise, culture, and incompatible record-keeping systems.
This backdrop is set against business priorities that demand organizations to do more with less. Pharmaceutical teams are asked to accelerate their pharmaceutical development programs, while reducing costs, improving quality and perfecting performance. To succeed, Pharmaceutical product and process teams need new information management capabilities to achieve their goals.
Yet, while some aspects of Pharmaceutical R&D have been transformed by advances in information technology, such as research and discovery, other critical areas of the lifecycle, such as product and process design, development, optimization, clinical manufacturing and tech transfer have largely been left unaddressed . Therefore, instead of realizing the benefits of comprehensive IT solutions, pharmaceutical and biotech organizations of all sizes have been primarily relying on custom databases, manual processes, paper based systems, ad hoc spreadsheets, word docs, and small, custom, disconnected databases for managing this mission critical product and process knowledge. Functioning under this handicap, the organization's ability to collect, share and learn from data generated at any given point in time throughout the lifecycle of drug development is severely hampered. Collaboration inside the organization and with outside partners often becomes more of a hindrance than a benefit.
Conformia's Product/Process Lifecycle Management (PPLM) solutions are the first enterprise solutions in the marketplace designed to address exactly these kinds of issues. PPLM will enable biotech and pharmaceutical development operations to create improvements in business productivity, visibility, scientific outcomes, and proactive compliance during the lifecycle of product development. Conformia's PPLM will enable companies to manage all of the product and process definitions, process understanding and scientific know how for today's climate and whatever tomorrow may bring.
Conformia's solutions are based on commercial off-the- shelf enterprise software designed to address the critical path from Lab to Launch. With Conformia a new era of drug development for the 21st century is possible through electronic data capture and correlation of integrated resource flows of people, materials, process, equipment, environment/ facilities, and standards in a single system across Drug Development.
Benefits of Conformia's PPLM solution include better decision making, greater operational efficiency for users as well as stakeholders, improved regulatory submissions, reduced risk to the corporation. Conformia customers are already benefitting from specific and measurable productivity improvements such as increased plant utilization, faster and more accurate root cause analysis, fewer manual inspections, and faster sign-offs. Find out how your organization can benefit from Conformia PPLM Solutions now!
To design and develop a solution that would yield these benefits, Conformia consulted with dozens of scientists, engineers, and business directors in pharmaceutical and biotech organizations. Using a "by industry, for industry" approach to development, Conformia produced a suite of PPLM solutions which incorporate rich resources of domain expertise and best practices. Conformia is honored to be collaborating with FDA under a Cooperative Research and Development Agreement (CRADA) formed to identify and analyze factors influencing pharmaceutical development, challenges and opportunities in how companies are implementing the ICH vision. Conformia also worked extensively with a top 10 pharma company to design and deliver this off the shelf enterprise PPLM system.
If you're seeking to improve your company's Product and Process Development efficiency, efficiency, reduce risk, protect IP, manage clinical supplies, accelerate implmentation of the 21st century paradigm and the ICH Vision for CMC, as well as stay off the critical path, Conformia’s PPLM may be able to help you.
Find out more about Conformia's Solutions for Life Sciences »