Validating validation individual development plan
Recently, the UK's MHRA has run a series of blog postings on data integrity - what it is and what it ain't from the regulators perspective.
Here are the three worth reviewing: The last one is of particular importance because so often c GCP compliance gets the short end of the stick when it comes to public data integrity enforcement.
If you've been wondering why people are reopening and reviewing FDA's 2013 guidance, Blood Establishment Computer Validation in the User's Facility, then the short answer is that it offers fairly concise information and guidance on what FDA expects around modern computerized system validation when it comes to testing and ensuring data integrity.
Be aware that way back in the preamble to 21 CFR 11 Electronic Records; Electronic Signatures, question #65, FDA strongly suggested that this guidance (the draft version at least) was essential reading for all industries.
The proposal that is produced during the process can be submitted to agencies for possible funding.
introduction to the research topic, formulation of the problem, and justification for its selection;2. Title page The purpose of the title page is to present a concise statement of the subject of the research and to identify the responsible researchers.Looking for reliable, "how to" information around data integrity on the web can be a bit of a challenge.One man's "data integrity" is another man's "data quality" is another man's "data governance." Without delving into the minutiae of each of these perspectives, I thought I'd offer up five of the resources I frequently call upon when conducting data integrity audits and data integrity training.Even though this is from 1991, there is a lot of good information within this section of the policy (e.g., it's an oldie but a goodie).Of course, this all presumes you haven't already bookmarked Cerulean's resource library for data integrity-related articles, case studies, interviews, and so on.