Everything we do today is traceable. The integrity of the data, documents and decisions needs to be defendable and consistent. Electronic Quality Management Systems (eQMS) are an effective way to...
The attention of regulatory agencies continues to focus on data integrity, as observed by the increase of FDA observations over the course of the last few years. Having a proper data lifecycle / data...
Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017. If you don’t want to review the entire guidance, here are...
Data integrity has recently been in the agency spotlight. In part because of the draft data integrity guidance issued April 2016, but primarily due to an increased number of inspection findings...
Managing compliance for computerized lab systems includes the PC controlling your qualified instruments. This is an integral audit point that must be maintained to ensure compliance. Ah, but you’re...
For those of you unaware, the FDA submitted a draft guidance on data integrity for comment in April. This is significant in that the last formal written guidance provided from FDA on this subject...
In today’s validated lab environment, knowing the importance of an audit trail in computerized laboratory systems is just one of the integral qualification tasks that the ProPharma’s Computer System...
Data integrity is a current hot topic, but not a new one, within the life sciences industries and associated product supply chains. This article will not delve into why there have been so many recent...
computer susteIt’s a Friday afternoon. Quarter’s end. Your V.P. of Regulatory Affairs calls your office bellowing something about not being able to process the latest submission data- can’t access...
The diagram below depicts an example CSV lifecycle alignment with ASTM E2500 and GAMP. Building onto a previous post, Lean CSV - How to Reduce Waste and Increase Value, today's blog focuses on...
Unverified Design – An Example For those of us who travel routinely, one of the most sought-after treasures in the typical airport terminal is an electrical outlet. With our dependency on mobile...
How are you doing with those New Years’ resolutions? Whether or not you’re a resolution maker (or breaker), you can use this time of year to take stock of where things stand, including your validated...
What is lean? Lean is a business system focused on continuously improving processes by reducing the time taken and the waste involved in delivering increasing value to the customer. Customers in this...
Introduction Risk based approaches to validation of computerized systems have been heavily promoted since the publication of GAMP 5 and ASTM E2500. Yet we continue to see examples of validation...