Rightsizing the Time and Cost of GxP

Rightsizing the Time and Cost of GxP

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  1 Rightsizing the Timeand Cost of GxP Compliance in Life Sciences
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  2 Introduction Erring on theside of excess in GxP validation (compliance) can mean additional time, cost, and resources with no benefit to any stakeholder — the life sciences company, regulatory bodies, or healthcare consumers. And it diverts the business from its core focus of developing therapeutics to prevent and alleviate health conditions.
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  Rightsizing GxP complianceis the sweet spot, but it can be tricky. It requires deep expertise in 21 CFR Part 11 regulatory requirements governing pharmaceutical, biotech, and medical device firms. And it demands in-depth knowledge of IT systems. Done right, GxP compliance contributes to quality and integrity across product and supply chain lifecycles. 3 GxP Compliance Pharmaceutical Industry
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  Some life sciencesfirms choose to tackle GxP compliance on their own. They invest heavily in internal teams of compliance and IT professionals to sort out compliance requirements across enterprise IT systems, with reporting to the U.S. Food and Drug Administration (FDA). 4 Challenges and Risks of GxP Systems Validation Process (IT Systems Validation)
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  Understanding the “justright” balance point between underdoing and overdoing GxP compliance is essential. And going forward, that knowledge supports ongoing compliance change management as IT systems and business requirements evolve. As life sciences leaders know, GxP is just one of several compliance challenges confronting the industry. 5 Sidestepping GxP Compliance Cost and Complexity
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  So how doesGxP validation and compliance work? Let’s take an example of a life sciences company that’s engaged Jade Global to implement the Boomi AtomSphere Platform for integration across internal and external partner systems. The client can select Jade’s pre-built validation jumpstart kit, including templates and frameworks, to handle GxP validation compliance with an internal team. Or the client can have Jade handle end-to-end validation processes as Boomi is implemented. 6 GxP Compliance for Enterprise iPaaS
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  A holistic approachequips a life sciences startup or midsize company to orchestrate, under a single umbrella, three focus areas instrumental to short-term success and long-term prosperity: • Digital transformation with a unified enterprise ecosystem • DSCSA-mandated track and trace for end-to-end supply chain visibility • GxP-compliant IT systems that satisfy 21 CFR Part 11 requirements 7 A Holistic Approach to Top Life Sciences Objectives
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  8 About Jade Jade withISO 27001, CMMI® SVC V2.0 Maturity Level 3 certifications, is well-positioned to be your strategic IT services partner. We create value through our vast portfolio of IT services delivered by highly skilled and experienced consultants. Our services include business application implementations, integrations, software product engineering, cloud services, technology advisory, testing, and managed services. We have domain expertise in a variety of industries including manufacturing, high-tech, energy, pharmaceuticals and warehouse distribution.
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  9 Headquarters 1731 Technology Drive,Suite 350 San Jose, CA 95110, USA Phone +1-408-899-7200 Email [email protected] Website www.jadeglobal.com USA I CANADA I UK I AUSTRIA I INDIA www.jadeglobal.com THANK YOU To Know More About our Services, Visit: https://www.jadeglobal.com/industry/life-science-and- health-care
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  10 Headquarters 1731 Technology Drive,Suite 350 San Jose, CA 95110, USA Phone +1-408-899-7200 Email [email protected] Website www.jadeglobal.com USA I CANADA I UK I AUSTRIA I INDIA www.jadeglobal.com Read Blog https://www.jadeglobal.com/blog/rightsizing-time-and-cost- gxp-compliance-life-sciences