Explore how digital transformation is revolutionizing the life sciences industry. Learn how Compliance Group Inc ensures ...

Explore how a risk-based validation approach enhances regulatory compliance and reduces costs. See how the combination of CG ...

Discover how a risk-based CSA approach combined with paperless validation streamlines compliance, boosts efficiency, and ...

Also meet our experts Caroline Honold and Swati Amanabolu onsite to discuss AI Validation, CSV/CSA, Veeva Vault, Polarion ALM, and the upcoming ISPE Digital Validation Tool (DVT).

Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and ...

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 ...

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

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 ...

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 ...

Companies in the life sciences, food, and cosmetics industries are all too aware of how fickle the market is, how dynamic their studies and those under investigation are, as well as their timelines ...