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Latest Compliance Update for Computer Systems

Learn from FDA and Industry Practioners and get Tools for Implementation
June 18, 2009

Risk Based  Computer Validation and Part 11 Compliance

With Strategies for  FDA/ISO Compliance and Tools for Implementation

Validation and Use of Excel Spreadsheets in Regulated Environments

Strategies for  FDA/ISO 17025 Compliance and Tools for Implementation

Requirement Management for Equipment and Computer Systems (213)
Strategies for Development, Documentation and Updates or Requirement Specifications

IT Infrastructure and Network Qualification
Introduction and Strategies for Compliance and System Uptime

February 28, 2008

Auditing Computer Systems for FDA and EU Compliance (211)
For Validation and Part 11 Compliance in Pharmaceutical and Device Industries

February 28, 2008

Validation of Existing/Legacy Computer Systems (207)
FDA/EU requirements and strategies and tools for implementation


Cost Effective Software and Computer System Validation
Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5


Master Planning for Software and Computer Validation
With examples for master and several project plans


Contingency and Disaster Recovery Planning for Computer Systems
To Ensure Business Continuity and Compliance

Understanding and Implementing the New EU Annex 11
Learn about specific requirements and get tools for implementation

Learning from Recent FDA Warning Letters Related to Computer System Validation and Part 11
With Clear Recommendations for Corrective and Preventive Actions

FDA's New Guidance on using Computers for Clinical Trials
FDA's New Approach Towards Computer Systems

Retirement of Computer Systems (170)
Strategies for FDA Compliance and Tools for Implementation

Review of IVT's 10th Annual

Computer and Software Validation Conference

With John Murray, FDA's Computer Compliance Expert

May 18-20, 2009    

Video Update from John Murray on current status and future of 21 CDR Part 11

The video is available for Lacompliance Userclub Members. For information, preview and registration, click here                                       

Plenary Lectures and 30 Workshops/Discussion Sessions Addressed Everybody's Needs

This year's format of the annual conference with plenary lectures and four parallel workshop sessions did address the needs of beginners as well advanced validation experts. The plenary lectures did address FDA updates and new trends. In 30 workshops and interactive discussion sessions attendees not only got good recommendations from industry practioners  but could also discuss and work on development of validation documents. Most remarkable was that FDA did not only provided a well recognized speaker for the conference but also did send several attendees to learn all details about compliance requirements for computers and electronic records. 

For those who could not attend, Dr. Ludwig Huber will give a detailed summary with key findings and recommendations in an audio seminar.    


The Chairman Dr. Ludwig Huber (middle) with FDA's computer compliance expert John Murray (left) and Martin Browning. Martin has been working for the FDA for several years and helped to develop several key FDA documents, for example, the CFR 820. Like Ludwig Huber also Martin was plenary speaker at all 10 annual IVT CSV conferences.

Key Learnings

  • Validation experts are advised to focus and better define User requirement Specifications.
  • Device industry still makes all types of mistakes related to computer validation. The number of warning letters in this area is increasing.
  • The inspection focus for pharmaceutical industry is on data integrity with an increasing numbers of 483s and warning letters. The main question to be asked is: How can you demonstrate, that your printed computer records have not been changed on the computer, and if so, is there a reliable audit trail. In case of any doubt inspectors will ask for electronic raw data and the procession steps to get to final results,
  • Several FDA employees did attend. the conferences, for example, to learn how to detect falsification of electronic records. This may be part of FDA's training program to detect computer related fraud as announced by FDA's Edwin Rivera at the International GMP conference two years ago.
  • It seems that with the new Annex 11 European legislation is ahead of FDA related to using software and computer systems.
  • With computer system validation becoming more and more mature the questions are not that much much related to validation principles any more but how can validation become more cost effective. Using a risk based approach for all validation steps, leveraging vendor validation efforts and standardizing validation processes with procedures and templates used throughout an organization are the tools to make validation more cost effective.

Attend Ludwig Huber's audio seminar to get all the details .

Conference Highlights - Plenary Lectures

  • FDA's computer compliance expert John Murray gave an overview on FDA's findings when reviewing software and computer validation documents.
  • Martin Browning, former FDA computer expert, gave recommendations on how to comply with FDA expectations for CSV and data integrity
  • Conference Chairman Ludwig Huber informed the audience about the new EU GMP Annex 11 on 'Using Computerized Systems'. A comparison with FDA's Part 11 revealed that Annex 11 is more complete. It addresses all aspects of Good Computer Compliance Practices with focus on quality, integrity and trackability of printed results to e-records.
  • Sharon Strause gave practical answers to the never ending question: How much validation is enough. Much of the answer comes from risk management.

Conference Highlights - Workshop and interactive Discussion Sessions

In about 30 sessions presenters gave a short introduction to the related topic. After that attendees worked on practical examples and case studies. Most presenters also made bonus material available, for example, case studies, SOPs, checklists and literature references.

  • Monica Cahilly's workshop focused on optimizing validation to ensure integrity of electronic records. She started with examples of FDA 483s/Warning Letters related to integrity of electronic records. Then she defined essential technical and procedural controls for electronic data integrity. In  the interactive part participants reviewed case studiers of various examples  to detect validation gaps.
  • Yana Collins of Vertex did lead a workshop on User Requirements. The importance of this topic has been brought up in several other presentations, for example, by FDA's John Murray. In the practical session attendees did apply various models to define URS.
  • One of the best attended session was Ludwig Huber's interactive discussion session on FDA requirements for audit trail. Amongst the audience were at two FDA employees who wanted to learn how to detect falsification of electronic records.  Attendees did go through various applications based on what they have learned and with prepared graphical templates could easily decide which systems need electronic audit trail. Ludwig Huber also handed out several bonus materials, for example, and SOP and checklist for specification and implementation of electronic audit trail.
  • Viramy Ortiz discussed (existing) legacy systems. She pointed out the importance of standardization for validation of existing systems. In the interactive part attendees did get tools to identify the validation scope and steps of legacy systems.
  • Tyson Mew of Ofni Systems, inc, lead the workshop 'Conducting an Effective Gap Analysis of CSV Programs'. He started with examples from FDA warning letters and then did go through the entire validation process.
  • Probably the best attended workshop was entitled 'Inspected! My Comapny! What to do?' by Sharon Strause. Sharon gave recommendations preparation, conduct and follow up of FDA and other inspections. In the interactive part participants discussed concerns regarding FDA inspections.   
  • Barbara Nollau of Abbot did lead a discussion an Risk Based Validation. She introduced the newly launched GAMP 5 model with focus on risk management and supplier management.
  • Ludwig Huber gave an overview on new regulatory and industry guidelines related to validation of  laboratory computer systems. He specifically focused on USP <1058>, EU Annex 11 and .GAMP 5. In the interactive session the attendees did get templates to develop key validation documents for chromatographic data systems. As bonus material attendees did get SOPs on implementing USP <1058> and a full set of 9 validation examples for a chromatographic data system.   

Selected photos with annotations 

Plenary lectures and four parallel workshops and interactive discussion sessions was an ideal forum for both beginners and advanced validation, IT and QA specialists.
  Each of the 10 annual conferes did draw big cowds, For example, more than 300 attended the conference in 2003
FDA's John Murray told the adience about most important mistakes the industry is making when validationd software and computer systems

He also gave an update on the status of 21 CFR Part 11
After public qestion and answer session Jogh Murray also anwered individual questions
John Kirchner has been managing this conference since 1999.

Here he talks to Sharon Srauss about organizing Sharon's workshop on FDA inspections. .
I would like to thank
John Kirchner of IVT/CBI for inviting me as keynote speaker and chairman. I also thank all attendees for great discussions. .