GEP Successfully Secures GxP Compliance, Ensuring Sanctity of Supply Chain Data in Pharmaceutical, Food and Life Sciences Industries

– Independent GxP assessment verifies GEP SOFTWARE’s tamperproof ability to track, trace and audit every ingredient and component across global supply chains

– GEP is one of the few supply chain SaaS providers that is GxP-compliant

GEP®, a leading provider of procurement and supply chain software and services to Fortune 500 and Global 2000 enterprises worldwide, announced it has successfully achieved GxP compliance following as evaluation by one of the big four accounting and consulting firms. It was secured as an integral requirement for one of the world’s leading pharmaceutical companies to operate all of its supply chain using GEP SOFTWARE™, the next-generation, cloud-native supply chain and procurement unified platform.

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The successful completion of the GxP audit ― termed the 21 CFR Part 11 Assessment in the U.S. and Annex 11 in the European Union ― verifies GEP SOFTWARE capability in supply chain collaboration, visibility and traceability up to lot/batch level, execution and control for all ingredients, raw materials and components used by the highly regulated food & beverage, biotechnology, pharmaceutical, and medical device industries.

Pharmaceutical, food and life sciences industries are accelerating product innovation, testing and production, and relying on an expansive array of suppliers, manufacturers, testers, packagers, and distributors from across the globe. GEP SOFTWARE ensures manufacturers’ ability to track and trace every ingredient, component, and audit across their entire supply chains, guaranteeing the quality and integrity of the drug or product. GEP provides companies with visibility, control and the ability to collaborate with suppliers, contract manufacturers, packagers and distributors over their entire multitier, multi geographic global supply chains.

“While complying with GxP regulations is quite complex and onerous, we are very happy that GEP achieved compliance with GxP standards for our software that enables global enterprises operating in highly regulated sectors to manage their distributed supply chains with a large network of suppliers, contract manufacturers and packagers,” said Vinayak Agashe, GEP’s vice president of product. “GEP enables companies to orchestrate their supply chains effectively, efficiently, and in compliance with the evolving regulatory requirements and to guarantee the integrity of every ingredient, supplier, and step in their process.”

GEP SOFTWARE and its processes have now been validated for U.S. and European GxP regulations. GxP regulations include the requirements outlined in the U.S. Food and Drug Administration (FDA) CFR Title 21 Part 11 and European Union (EU) Annex 11 to ensure that businesses working in regulated industries manufacture products that are safe and fit for use, meeting strict quality standards throughout the entire process of production. As part of its software implementation for one of the world’s leading pharmaceutical companies, GEP engaged one of the world’s most highly regarded consulting firms on the U.S. Food and Drug Administration (FDA), European Union regulations and international regulatory compliance issues that impact the pharmaceutical and medical device industry. The audit evaluated GEP as a SaaS-hosting provider with special emphasis on processes and controls in place for the design, development, testing, release, validation, and hosting of software and associated quality management.

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