Ad hoc testing and software assurance

As a validation engineer with over 30 years of experience, I am well aware of the need for rigorous testing of software applications to ensure their readiness for production use.  The new software assurance methodology promoted by the US Food and Drug Administration endorses the concept of ad hoc testing. In today’s environment where cloud […]

Mastering software assurance a practical approach

The FDA has announced a new approach to computer systems validation.  The FDA will no longer use the term ‘Computer Systems Validation’ anymore or for that matter ‘Independent Verification and Validation (IV&V)’. The new name is ‘Software Assurance’.  So what is Software Assurance and why do you care? Life sciences companies are experiencing a technology […]

Cybersecurity qualification: the elephant in the room

Cyber security threats are everywhere.  Threats posed by cyber-attacks are real.  For most businesses, it is not a question of if you will be attacked, but when.  Recent headlines have focused our attention on the need for greater due diligence to combat cyber threats.  In validation circles, many validation engineers have failed to directly address […]

Now is an excellent time for validation strategy reboot

It’s that time of year where we start to make resolutions and think about better ways to conduct our business with respect to validation. Now is a great time to start rethinking your validation strategy based on the pending guidance that is to come forth from the FDA regarding software assurance.  You may have heard […]

Women in Validation: In Case You Missed It

One of my annual “must attend” events is the Institute of Validation Technology (IVT) Computer Systems Validation Annual Validation Week in October.  This is an excellent event to get the latest and greatest thinking on validation topics and industry guidance.  An official from the U.S. FDA attended the event and providing key information on the […]

Is Your Validation Team Ready For GDPR?

GDPR stands for the General Data Protection Regulation.  It governs all personal data collected by companies for customers, potential customers, employees, and others.  Regulators are keen to understand how this information is managed and maintained over time. In April 2016 the FDA issued new draft guidance for data integrity and compliance with cGMP. The guidance […]

Cybersecurity Qualification (CyQ)

One topic that has been top of mine for many validation engineers, chief information officers, and executive management is that of Cybersecurity. You may be asking yourself the question why are we talking about Cybersecurity and validation? Recent headlines will inform you as to why this topic should be of great interest to every validation […]

In Case You Missed It: CSV ValidationMaster Class

In case you missed it, in December 11- 13 KenX conducted the Computer System Validation and Data Integrity Congress.  Recently, the FDA has issued warning letters regarding non-compliance of validated computer systems.  Findings have included issues such as inadequate risk analysis, non-independent audit trails (audit trails that could be manipulated or turned on/off), failure to […]

What Data Integrity Means For Validation

After much fanfare, the general data protection regulations (GDPR) was approved by the EU parliament on April 14, 2016. The enforcement date for this regulation is May 25, 2018. If companies are not in compliance at that time the potential for heavy fines is inevitable. The EU general data protection regulation replaces the data protection […]

Saving Time and Money Through Lean Validation

The principles and best practices of lean manufacturing have served life sciences manufacturers well.  Lean is all about optimizing processes, while eliminating waste (“Muda”) and driving greater efficiencies.  As a 30-year validation practitioner, I have validated many computer systems, equipment and processes.  One of the key lessons learned is that there is much room for […]

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