Skip to main content Skip to main navigation Skip to search Skip to footer

LIMS – The Risk-Based validation option - PoV

LIMS – The Risk-Based validation option - PoV

Risk-based validation requires that risks posed by software systems that may be detrimental to patient safety, product quality or data integrity, be managed. Conservative validation has been based on a generalized and simple but often over-cautious approach to human health risk assessment. Complete end-to-end validation of a software system may not be the most cost effective way forward. The move by the pharmaceutical industry towards a risk-based approach of validation has been facilitated by FDA‟s significant initiative towards a scientifically-driven risk-based approach to validation.

Contact Us
MAX CHARACTERS: 10,000

We will treat any information you submit with us as confidential. Please read our privacy statement for additional information.

We will treat any information you submit with us as confidential. Please read our privacy statement for additional information.