Description: As industries in the Life Sciences undergo digital transformation, moving away from traditional Computer System ...

Compliance Group is proud to be a part of Veeva Summit 2025 as a Silver Partner. Connect in Boston, Sept 2–4, to explore ...

In today’s fast-evolving life sciences industry, leveraging Veeva’s cloud-based solutions is critical for maintaining a competitive edge. To drive long-term efficiency, the Veeva Services team ...

In this session, Compliance Group (CG) will showcase a Siemens ISV low-code Mendix mobile app enabling Manufacturing and Quality leadership to answer questions they have struggled with for years – ...

Quality Records and Documents – Non-Conformances (NC), Corrective Actions and Preventive Actions (CAPA), Change Requests (CR), Bill of material (BOM), Complaints, SOPs, Work Instructions, ...

So, Quality Management System has produced a step-by-step process to help companies handle the CAPA process to get satisfactory results in adherence to ISO (International Standards Organization) FDA ...

Organizations must develop a written method to approve papers for sufficiency prior to issuance. Documents should be reviewed, updated as needed, and re-approved. Determine the changes and the current ...

The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance ...

Title 21 CFR Part 11 is the portion of Code of Federal Regulations that provides standards determined by the Food and Drug Administration (FDA) on electronic records and electronic signatures. With ...

In the life sciences industries, documentation plays a crucial role in proving the product’s effectiveness and safety. Furthermore, it discusses the processes and practice’s dependability, ...

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medical devices’ safety, efficacy, and quality. The agency has developed a rigorous medical device ...