ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
October 19, 2021
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...
October 15, 2019
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...
October 12, 2017
Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017.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...
May 23, 2017
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...
September 28, 2016
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...
May 4, 2016
For those of you unaware, the FDA submitted a draft guidance on data integrity for comment in April.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...
April 14, 2016
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...
March 3, 2016
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...
July 30, 2015
It’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 system. Then...