AI evolves continuously, and oversight must keep pace. Validation makes AI dependable by ensuring models are transparent, testable, and inspection-ready throughout their lifecycle. Successful AI ...

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 ...

Since the release of the FDA draft on Computer Software Assurance (CSA), September 13th, 2023, many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11. The ...

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 ...

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 ...

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 ...

For health and life sciences organizations, compliance with regulatory requirements is non-negotiable. Historically, Computer Systems Validation (CSV) has been the focus of QA and compliance ...

When a company is issued an FDA 482 Notice of Inspection and FDA 483 Warning Letter, it must prepare and be ready for the long adventure it will have to take with the FDA. Receiving an FDA 482 means ...

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 ...

Bird-brained. Has anyone ever been called that? It’s definitely not a compliment. However, a bird’s eye view is considered good, like being in the crow’s nest or traveling straight as the crow flies.

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 industry face challenges in developing and maintaining data integrity due to complex validation documentation. Maintaining data consistency, accuracy, and integrity ...