Test automation – Necessity versus luxury

Before the pandemic, there were still a considerable number of life sciences organizations conducting all types of validation on paper.  These organizations were continuing to manually sign validation documentation on paper and scan in the signed results.  They resisted the use of electronic signatures or any automation that would drive efficiency and greater compliance.  These […]

Using artificial intelligence to accelerate Microsoft Dynamics 365 validation

Many organizations are adopting Microsoft Dynamics 365® at an accelerated pace.  Microsoft Dynamics 365® Enterprise Resource Planning System is an excellent choice for supply chain management within global organizations. As with any validated system, validation engineers struggled to maintain the validated state.  Cloud environments complicate this process in that the validation engineer does not have […]

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 […]