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).

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 development of new medical devices or any new project brings a new set of risks. A Risk Management Plan (RMP) must be developed at the start of the Risk Management Process for a new project or ...

Packaging and sterilization validations are a critical step in the development and manufacturing of medical devices, as they ensure patient safety, regulatory compliance, product quality, and the ...

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 ...

The significance of FDA Computer Software Assurance (CSA) cannot be overstated when it comes to laboratory systems in today's technological era. Embracing the CSA methodology is crucial as it promotes ...

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 ...