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Labcompliance News, May 2004

May 17, 2004

My Computer System is High, Medium or Low Risk. What does this mean?

FDA’s Part 11 guidance on Scope and Applications recommends to base several part 11 related decisions on risk assessment. Frequently risk categories are easy to define but the real challenge comes when users should take action to optimize risks versus costs. The question has been answered very much in detail by Dr. Ludwig Huber in an interactive discussion session at the Annual IVT Computer Validation Conference in Washington on May 5, 2004. With 130 people the session was the most well attended out of all break-out sessions "What you need are three things", Dr. Huber said:
Define risk category for each system
Define scope and controls for part 11
Define tasks for all computer validation step based on risk, complexity and level of customization as defined in GAMP4.

Once implemented right this process can save a lot of money and increase the confidence in FDA inspections. As part of the handout Ludwig Huber presented SOPs for each step as mentioned above. Those who could not attend the IVT session can get the information with all reference material in an On-line Audio Seminar. For a more detailed outline of risk based computer validation, click here.

May 17, 2004

Update on Part 11 by FDA's John Murray

At the IVT Annual Computer System Validation Conference in Washington John Murray of the FDA gave an update on FDA's 21 CFR Part 11. He addressed most critical issues on how the FDA approaches enforcement of part 11. He explained why the scoped has been narrowed and part 11 needs to be re-examined: "Industry consistently expressed concerns that some interpretations of part 11 would unnecessarily restrict use of electronic technology, significantly increase costs of compliance and discourage innovation and technological advances". Mr. Murray also explained where the FDA intends to apply enforcement discretion. This seems to be not well understood by the industry and inspectors. Therefore the FDA is issuing an new guidance describing how they intend to exercise enforcement discretion for certain Part 11 requirements while we re-examine Part 11. Mr. Murray explained which requirements do not fall under enforcement discretion and gave some examples on when part 11 will be enforced.

May 14, 2004

Ten New Documents in the Users Club Section

We have put 10 new documents in the LabCompliance Users Club. They include:

  • The proposed IVT Standard on Network Qualification
  • FDA's 40 page Laboratory Information Bulletin on “Validation and Design of Spreadsheets” (not available on the public FDA website)
  • A checklist for Validation of Laboratory Computer Systems,
  • Several SOPs for Part 11 Control and Computer Validation
  • Three Warning Letters with deviations related to Quality Systems, FDA’s new focus at inspections.

With this update, Labcompliance has close to 300 documents and video clips in it's Users Club for instant download. For information and registration click here.

May 14, 2004

New FDA Drug cGMP Expected to be Released in August

The FDA plans to release a revised version of 21 CFR Part 211 in August this year. The draft has been released in 1996. This is a 'fundamental reform of the regulation, which have not been revised for 25 years" said Acting FDA Commissioner Lester Crawford at the Food and Drug Law Institute's 47the Annual Conference on April 15 in Washington. "Previous changes were not a fundamental reform of the regulation. They were the best we could do at that time". Crawford said. Labcompliance expects that the new regulation is in line with FDA's 21st century initiative for drug cGMPs. Risk based compliance combined with more emphasis on quality systems will most likely be the major differences to the existing regulations. Labcompliance will report on the new regulation in it's newsletter and will also conduct an audio seminar to inform subscribers about the new regulation.

May 12, 2004

FDA Compliant Configuration Management and Change Control

It is well known that most problems of software, computer systems and networks are introduced when changes are made, either during development or during use of the systems. Inadequate documentation of changes and testing after changes are amongst the most frequently cited deviations during FDA inspections. Users of the system, system owners and network administrators are unsure on how to document initial set-up and manage changes. Answers are provided in an audio online seminar. For information and registration, click here

May 12, 2004

IVT Computer System Validation Conference - The Most Successful Computer Validation Event Ever

The IVT Annual Computer System Validation conference in Washington was attended by more than 330 people. "This is the best attended conference on computer system validation ever in the history' said Glenn Glenn Melvin, president of IVT. Keynote speakers have been John Murray, US FDA, Ludwig Huber, Agilent Technologies, Akos Bartha, Astra Zeneca, Peter Bosshard, Roche and others.