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HCL Technologies

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.

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