Online Safety Community

FDA and EU requirements on data integrity and implementation

Data integrity and its implementation in cGMP records are major requirements from the FDA. The FDA considers these as important requirements to ensure the integrity of data in these records. The FDA’s, as well as the EU’s requirements are set out for ensuring both data integrity and its implementation are set out in 21 CFR Part 11 and Annex 11 respectively.

Data integrity is part of FDA 21 CFR Part 11, which essentially deals with the veracity of electronic records and electronic signatures. It applies to records designated or set forth in Parts 210, 211 and 212 of FDA regulations. The FDA’s 21 CFR Part 11 has its counterpart in Eudralex Annex 11, which also has more or less the same intention, but varies in some ways. Both the FDA’s 21 CFR Part 11 and Annex 11 are required for medicines that are introduced into the US and European markets. Annex 11 is basically about the implementation part of cGMP records.

What is data integrity?

First, a small understanding of data integrity: The FDA defines data integrity as a state in which the data is complete, consistent and accurate. The FDA uses the acronym ALCOA to describe this quality of data: Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate.  The requirements set out by the FDA on data integrity are applicable to metadata and audit trails as well, as also static and dynamic data. Static data is a physical record of which a paper record is an example. By contrast, dynamic data is the kind of record in which it is possible to make some interaction between the user and the creator.

Part 11 lists out criteria that the FDA considers all these: electronic signatures, handwritten signatures and electronic records that are done on electronic records to be reliable, truthful, and generally the same as paper records and handwritten signatures that are done on paper.

Get to understand 21 CFR Part 11 and Annex 11 better

The ways of actually ensuring and implementing data integrity as set out in both FDA 21 CFR Part 11 and Annex 11 of the Eudralex will be the learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings in the areas of regulatory compliance, will be imparting.

At this seminar, Angela Bazigos, CEO of Touchstone Technologies Silicon Valley, and a senior Regulatory Affairs professional who carries four decades of experience in regulatory affairs, will be the Director. To enroll for this highly enriching learning session on FDA 21 CFR Part 11 and Annex 11, please register for this session by visiting http://www.globalcompliancepanel.com/control/globalseminars/~produc... . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Explaining the history of these regulations

Angela will start this seminar with an explanation of how 21 CFR Part 11 and Annex 11 evolved, which will set the background to these laws. She will explain why these two regulations are now being talked about all over again. Offering an overview and key requirements of Part 11 & Annex 11, Angela will describe how to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance. She will then also illustrate how the FDA & other regulatory authorities inspect computerized systems for data integrity.

During the course of this seminar, the Director will cover the following areas:

o  What is Data Integrity and how is it implemented

o  How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?

o  Data Integrity Frequently Asked Questions

o  Validation Master Plan

o  Risk Based Assessment

o  Complete Validation for a System (software development lifecycle)

o  Automated Test Tools

o  Infrastructure Requirements

o  Change Control

o  SOPs.

https://www.fda.gov/downloads/drugs/guidances/ucm495891.pdf

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch....

http://www.pharmpro.com/blog/2011/09/how-far-does-annex-11-go-beyon...

Views: 154

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Madison Quinn posted an event

Pega Robotic Automation BPM Online Training at Online

October 20, 2017 all day
Pega Robotic Automation is equipped with an operating system that allows organizations to control all their robotics processes from a location. In combination with the Pega 7 BPM platform and case management applications, companies can seamlessly integrate human actions with robot automation for optimal workflow.Pegasystems introduces Pega Robotic Automation. It is now fully merged and available on the Pega 7 platform for case and business process management (bpm) and the portfolio of customer…See More
5 hours ago
Adam Fleaming posted a blog post

Learn How to Prevent Quality and Compliance Problems by having a strong system for Purchasing Controls!

In this era of globalization; outsourcing has become a major component of business. Outsourcing brings many benefits for companies. Short and long-term cost benefits, the ability to concentrate on their core activities and grow their business, and the freedom of avoiding the actual tasks that go into manufacturing are some of the stated…See More
yesterday
John Robinson posted blog posts
yesterday
Training Doyens posted events
yesterday

Forum

Risk Management Solutions

Risk is defined as the potential hazard, harm or side effect of an activity. Almost all activities come with some or another form of risk, which needs to be mitigated or eliminated. Risk management…Continue

Tags: risk, Banking, management, healthcare, Process

Started by John Robinson on Tuesday.

Occupational Health and Safety 4 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by John Robinson on Monday.

Introduction to PEGA-PRPC

Pega/PRPC is a popular rules engine and BPM tool from Pega systems that is gaining good market share among large corporations. Architects and developers build the Pega/PRPC instance while…Continue

Tags: training, course, online, pega

Started by Soujanya Naganuri Oct 6.

Introduction to PEGA-PRPC

Pega/PRPC is a popular rules engine and BPM tool from Pega systems that is gaining good market share among large corporations. Architects and developers build the Pega/PRPC instance while…Continue

Tags: training, course, online, pega

Started by Soujanya Naganuri Oct 6.

Introduction to PEGA-PRPC

Pega/PRPC is a popular rules engine and BPM tool from Pega systems that is gaining good market share among large corporations. Architects and developers build the Pega/PRPC instance while…Continue

Tags: training, course, online, pega

Started by Soujanya Naganuri Oct 6.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service