July 2002
System Validation SIG Update
After a very productive first meeting held at Pharmacia in High Wycombe in April, the System Validation Special Interest Group has eventually launched itself back onto the SIG scene.
The next meeting is planned in early July, again at Pharmacia in High Wycombe from 10.00 to 4.00. This first 'official' meeting will include a talk by Andrew Gold on Legacy Systems followed by a group discussion. We then hope to get members of the ACDM Website Sub-Committee to join us so that we can determine as a team how we would like to revamp the current SVSIG website page. It has still to be confirmed as to the discussion topic for this meeting although the two proposals are currently the 'Internal Promotion of Validation' or 'Monkey Testing and Negative Testing.'
As a group we intend to hold two meetings a year and once we have the website up and running we hope that all agendas for future meetings will be there for all to see.
Please however, see below for proposed presentation subjects and topics for discussion that the group have planned for the future!
Proposed Presentation Subjects
Topic: System validation processes and documentation -
with respect to both New and Legacy Systems.
Topic: Good Clinical Practices (GCP) and Validation -
Reponses to development of GCP directive.
Topic: Topic: 21 CFR Part 11 (Electronic Records and Electronic Signatures) -
Responses to development of ERES
Topic: How much validation is appropriate for different system types, a CDMS vs a Query Management system for instance.
Level of validation.
Defining an understanding of CSV, the implications and ownership of the "plan".
Levels of documentation – Documentation, what is "enough"?
Defined Life Cycle activities documents.
Topic: How to prepare for an FDA audit (our worse case scenario??).
Focus at DIA - someone to give a talk on being audited?
Topic: How much work is required after the system is validated?
Presentation on Change Management?
Topic: Structured Development Methodologies
What they contribute to validation and vice-versa
Topic: Data protection and privacy
Topic: How to measure the quality return on business investment and the role of validation.
Turning validation into cost benefit up and down the company -
change management, people, money, resources, efficiencies, head count etc.
Topic: External Vendor responsibility versus clients.
Proposals for Future Discussion Topics
Discussion Topic: Internal promotion of validation.
Discussion Topic: Monkey Testing and Negative Testing.
Discussion Topic: What regulations should the industry be working to?
CFR 21 Part 11, GCP, ISO9000, etc. Suggestion that the group decides on topics to research and then feed back to the group and discuss - this will also be linked to Risk Management. We may seek to have a speaker for this topic with the intention being a Regulator to give a talk on compliance issues.
If you are interested in joining the SIG, please contact Alison Jordan: alison.j.jordan@pharmacia.com
Alison Jordan
Chairperson, System Validation Special Interest Group