Insight and opinion
Part two of the two-part ‘Lean Validation’ series, “Managing Value Through Lean Validation” explores the management of value-added and non-value-added…
Part one of the two-part ‘Lean Validation’ series, “Achieving Lean Validation in GxP Organizations” explores Lean, it’s origins and how…
COVID-19 has become a stark reminder of the threat pandemics pose to the continuity of critical industries and the vital…
What is Computer Software Assurance (CSA) and why are the FDA transitioning from traditional Computer System Validation?
The FDA’s new approach, Computer Software Assurance (CSA), represents a significant paradigm shift and places critical thinking at the centre of the CSV process, as opposed to a traditional almost one size fits all approach.
Technology is often cited as an industry with low equality in employment gender representation, a trend that trailblazing women have …
By Eddie Ryan, Chief Executive Officer, Kneat Solutions | First published on learnaboutgmp.com Companies operating in the life science industry…
Regulatory expectations related to GxP validation have increased in both inspection focus and in complexity. And it doesn’t get any easier when your company expands, with the related validation deliverables, effort and compliance risks increasing further.
In an effort to enhance consistent quality, address data integrity challenges, reduce costs, and minimize risk, Life Science companies are seeking to optimize their Validation processes. In doing so they naturally consider going paperless and typically look at an existing IT system, before considering a built for purpose paperless validation solution.
Data Integrity is a major concern for the global pharmaceutical and medical device industries, across many of their business areas. Global regulatory authorities have increased their inspection focus to ensure good Data Integrity practices are being implemented. The increased focus results from inspection observations of significant deficiencies.
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Process validation involves a series of activities taking place over the lifecycle of the product and process.
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