Kneat Blog

Paperless Validation System Versus A Hybrid Paper System

Posted by Kneat Solutions on 10-Oct-2017 12:00:00

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

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Topics: eVLM, Electronic Validation Lifecycle Management, Paperless Validation, Kneat

How Paperless Validation Systems Support Data Integrity

Posted by Kneat Solutions on 31-Jul-2017 10:50:27

 

Background

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.

 

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The Four Types of Process Validation

Posted by Kneat Solutions on 17-Jul-2017 13:02:35

 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 is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals (21CFR 211) and of the GMP regulations for medical devices (21 CFR 820) and therefore applies to the manufacture of both drug products and medical devices.

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The Difference Between a FAT and a SAT

Posted by Kneat Solutions on 29-Jun-2017 09:05:09

It’s a question commonly asked in the validation arena, what is the difference between a FAT and a SAT. This article will finally explain what the difference is and why each one is required.

Any project that involves equipment being developed from a third party should have a FAT and SAT incorporated into the system life-cycle. If both the FAT and SAT are performed correctly is will lead to a much easier IQ/OQ process.

What is a FAT

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Topics: Validation

Kneat Solutions Blog

Our next generation productivity software makes your Validation and Manufacturing processes paperless, more compliant and centrally managed.

Our customers are seeing productivity increase by more than 100% and cycle times reduced by more than 50%, leading to improved OEE.

Read about their results 

 

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