Regulatory Guidance On GMP Software

GxP refers to the good practice guidelines and regulations created to ensure that food, medical devices, drugs, and other life science products are safe and meet their intended use. The “x” in GxP refers different fields such as manufacturing (GMP), documentation (GDP) and clinical (GCP). There are organizations and government agencies around the world that oversee GxP compliance. They ensure compliance through regular inspections, enforcing appropriate certifications, and by running audits. The United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA) are the main organizations or government agencies that oversee and enforce GxP around the world.

If an organization is using a software to generate, store or transmit electronic records and those records are used to demonstrate compliance with regulatory requirements, 21 CFR Part 11 becomes applicable to the software. Similarly, if those electronic records are used for making a submission directly to the FDA or is relevant for an inspection, 21 CFR Part 11 will be applicable.

Use of software in a biopharmaceutical GxP environment provides many benefits to users and the organization, but also comes with stringent regulatory requirements. This whitepaper highlights some of those regulatory requirements and describes how software is invaluable for creating an audit trail, reporting, and automating regulatory-related tasks.