Computer Systems Validation
Life Science Consulting
October 19, 2021
Implementing eQMS in a Regulated Environment
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...
Computer Systems Validation
Life Science Consulting
October 15, 2019
Just How Mature Is Your Data Lifecycle / Data Management Function?
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...
Computer Systems Validation
Life Science Consulting
October 12, 2017
Summary Considerations: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017.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...
Computer Systems Validation
Life Science Consulting
May 23, 2017
Data Integrity 101: Is your data compliant?
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...
Computer Systems Validation
Life Science Consulting
September 28, 2016
Is Your Laboratory PC Cloned From the Proper Image?
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...
Computer Systems Validation
Life Science Consulting
May 4, 2016
Top Takeaways from FDA’s Guidance on Data Integrity
For those of you unaware, the FDA submitted a draft guidance on data integrity for comment in April.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...
CDER
GMP
April 14, 2016
Everything you to need to know about Audit Trails
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...
Computer Systems Validation
Life Science Consulting
March 3, 2016
CSV Considerations Around Data Integrity
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 Systems Validation
Life Science Consulting
July 30, 2015
Looking to the Cloud for your Business
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...