Effective & Compliant Lab Informatics Implementation Projects

Academy training PLA2020

Benefit of a unique dedicated workshop about software vendor selection and risk management completing successful lab informatics implementation projects

Transforming your laboratory and quality processes from paper-based to paperless ones require you to build on a very dedicated team for a lab informatics implementation and a very specific digitalization project. One key team member is your software vendor. 

At the Paperless Lab Academy®, we discuss about  the key aspects of such projects like for example how to set a realistic project scope, which milestones and expected outcomes are to be expected at short, medium and long term…

We’ve got through the change management aspect too, by implementing activities that would ensure that the human factor of the project would be carefully considered.

Fact is that little is mentioned about the key partner collaboration agreement to be set up. The software vendor is about to be your key partner in your project and crucial for an effective, compliant and successful software implementation and workflows validation.

During a software selection process we normally tend to focus on the product. Yet the vendor ability to stand along with you during the implementation is directly related to their own quality processes. Your ability to easily implement and validate the software is directly related to their software design.  It is about evaluating your provider and elaborate an accurate Risk Management.

The Academy Training proposes you a dedicated workshop 

Practical examples of Risk Management will be used throughout the workshop to demonstrate areas of focus, high risk and areas of low risk.

During a 4 hour workshop,  Mark Newton will take you through his best practices in software implementation and as such in vendor selection management. Mark brings his 35 years of experience in the pharmaceutical industry in QC Labs, computer systems validation and lab informatics at Eli Lilly.

Mark is also a very active member at the ISPE (1).  Co-leader for the GAMP Data Integrity Special Interest Group and Chair of ISPE Global Documents Committee.
Co-author of “Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification”  (2)
Co-editor of the GAMP Good Practice Guide “A Risk-Based Approach to Compliant Computerized Laboratory Systems” (3)

Last but not least, Mark is part of the advisory board of the Paperless Lab Academy® and contributes also with articles and webinars about #dataintegrity 


Monday, April 20, 2020 | pre-congress day | Baveno, Italy



(1) International Society for Pharmaceutical Engineering,  ispe.org 

(2) “Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification”  Schuessler, Newton, Smith, Burgess, McDowall. Pharm. Engineering, Jan/Feb 2014

(3) GAMP Good Practice Guide “A Risk-Based Approach to Compliant Computerized Laboratory Systems”



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