GEP Software is Now GxP-Compliant, Validating its Supply Chain Technology Capabilities
- Regulatory agencies in the U.S. and Europe have set up Good Practice (GxP) standards for businesses operating in food & beverage, pharmaceuticals, biotechnology and medical device
- The independent audit confirms the suitability of GEP Software’s supply chain technology for these highly regulated industries
- GEP software enables manufacturers to track and trace every ingredient and component across their multi-tier supply chain
Businesses operating in industries such as food & beverage, pharmaceutical, medical device, life sciences, biotechnology and others often come under the scanner since they must comply with stringent regulations and norms set up by regulatory bodies such as the U.S. Food and Drug Administration (FDA).
As a result, leading players in these highly regulated industries focus extensively on R&D and consistently engage in product innovation, testing and production.
Many of them have global supply chains that spread across different regions and include a wide network of suppliers, manufacturers, packagers and distributors. Such complexity makes it extremely difficult for players to monitor various entities in their supply chains, especially beyond Tier 1 suppliers.
What are GxP guidelines?
Regulatory agencies such as the U.S. Food and Drug Administration (FDA) have set up Good Practice (GxP) standards for businesses operating in industries such as food & beverage, pharmaceuticals, biotechnology and medical device. The objective of these regulations is to ensure that food and medical products are safe for use by consumers.
In the acronym GxP, x is a variable that changes according to the application. For instance, x can stand for ‘Manufacturing’, ‘Clinical’, ‘Laboratory’, ‘Storage’ or ‘Distribution’.
Organizations must comply with necessary regulations including stringent quality standards throughout the entire production process. They must follow procedures that are clearly defined and well-documented to cover critical processes. Additionally, the staff must be fully trained to implement these procedures and have clear understanding of their responsibilities.
The U.S. FDA Code of Federal Regulations (CFR) Title 21 Part 11 and European Union (EU) Annex 11 outline the requirements for businesses working in heavily regulated industries.
Validations from the audit
With the successful completion of the GxP audit, GEP Software has added another feather in its cap. This evaluation has validated GEP Software’s capability in supply chain collaboration, visibility and traceability.
GEP Software ensures that manufacturers can track and trace every ingredient, raw material and component across their multi-tier supply chains, thereby safeguarding the quality and integrity of their product. They can scan their extended supply chains and look beyond Tier 1 suppliers, which has become so critical in the pandemic-hit supply chains.
Commenting on the successful audit, Vinayak Agashe, vice president of product at GEP, said, “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.”
The audit, which evaluated the technology’s suitability for businesses operating in highly regulated sectors, validated GEP as a SaaS-hosting provider with a special emphasis on processes and controls. These processes and controls aid in the design, development, testing, release and hosting of software and associated quality management.
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