Jade, a Boomi Elite Partner offering IT and business consulting services, we specialize in helping life sciences companies achieve GxP compliance with the Boomi AtomSphere Platform

1. 1
Rightsizing the Time and Cost of
GxP Compliance in Life Sciences

2. 2
Introduction
Erring on the side 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.

3. Rightsizing GxP compliance is 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

4. Some life sciences firms 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)

5. Understanding the “just right” 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

6. So how does GxP 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

7. A holistic approach equips 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

8. 8
About Jade
Jade with ISO 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.

9. 9
Headquarters
1731 Technology Drive, Suite 350
San Jose, CA 95110, USA
Phone
+1-408-899-7200
Email
info@jadeglobal.com
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

10. 10
Headquarters
1731 Technology Drive, Suite 350
San Jose, CA 95110, USA
Phone
+1-408-899-7200
Email
info@jadeglobal.com
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