Quality Management
“We have helped many regulated companies implement GxP quality systems, driving lean compliance and providing pragmatic quality management processes that deliver long term business benefit”
Key Benefits
Subject Matter Experts
Team of GxP Quality and Compliance subject matter experts each with a minimum of 20 years' industry experience covering QA, QC, IT, production, laboratory operations, engineering and validation.
Proven Success
Experienced in auditing, introducing and successfully managing GxP compliance and quality systems to EU (EMA), US (FDA), UK (MHRA) regulations and international guidelines such as ISPE GAMP® and ICH.
Pragmatism
Implementation of agile Quality Management Systems (QMS) that are fit for purpose and tailored to meet our customers’ needs, recognising some of our customers work across multiple industry sector verticals.
Related Files
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Case Study: GCP Compliance Audit and Action
“The Formpipe team’s support enabled us to identify and appropriately manage our regulatory compliance challenges and assured that the final deliverables met the expectations of both the regulators and our company’s leadership team. Formpipe delivered a complex, high profile and business critical project within time and budget and enabled our business meet its improvement program objectives.
I would recommend Formpipe as a smart, agile business partner and service provider that delivers measurable results and performance benefit.”
Senior Vice President, Ranbaxy Global Quality
