Computer Validation Initiative Committee Membership Requirements

Transcription

1 SOP No. CV Supersedes SOP No. CV Effective Page 1 of 5 Original Issue 18 February 2002 Retirement Computer Validation Initiative Committee Membership Requirements 1. Significant Change(s) from Previous Version Section 5 - Process changes in membership requirements. Attachment A: Revised SQA CVIC Member Profile (i.e., application form). 2. Purpose The purpose of this Standard Operating Procedure (SOP) is to describe the membership requirements for Computer Validation Initiative Committee (CVIC) and the process for adding, removing, and maintaining membership. 3. Scope Computer Validation Initiative Committee (Specialty Section) 4. Responsibilities This SOP applies to Potential Members, Members, Chair, Membership Administrator, and CVIC Executive Committee. 5. Procedures 5.1 Apply for Membership SQA members who are interested in joining the CVIC should contact the CVIC Membership Administrator, the CVIC Chair, or SQA Headquarters (HQ) The Membership Administrator, in response to an SQA member s interest in the CVIC, shall send a SQA CVIC Member Profile form (see Attachment A) The Membership Administrator shall review the completed SQA CVIC Membership Profiles to assure that the potential member has completed the

2 Page 2 of 5 application form. If not, the Membership Administrator will return the form to the SQA member with additional requests The Membership Administrator shall forward the potential member s completed application form to the CVIC Chair for review If the criteria have not been met, the Membership Administrator shall inform the applicant that their application has not been approved for membership If the criteria have been met, the Membership Administrator shall: Update the CVIC membership database to include the applicant s details and skills/experience Notify SQA HQ to add the applicant to the CVIC Specialty Section Inform the applicant that their application has been approved for CVIC membership. 5.2 Membership Requirements CVIC Members are required to participate in the activities of this specialty section. Participation is defined by attending meetings (at least two per year, physical or remote attendance) and active participation in CVIC activities, such as training, writing articles, serving as an Officer, Liaison, or Subcommittee Chair/Member, etc. 5.3 Review of Member Participation and Meeting Attendance The CVIC Secretary and Membership Administrator shall maintain a quarterly meeting attendance list The CVIC Executive Committee shall: Review the attendance list and Meeting Minutes (at least annually) Determine whether the members are participating at acceptable levels in accordance with Section The CVIC Chair shall contact members who have not fulfilled the membership requirements to notify them that they have been removed from CVIC The Membership Administrator will notify HQ of those members removed from CVIC. Note: Such members may reapply for CVIC membership once they can commit to the participation requirements described section

3 Page 3 of 5 6. Other Documents to Consider Attachment A: SQA CVIC Member Profile SOP Reviewed by: Approval on File Elliott Graham, RQAP-GLP SQA Executive Director SOP Approved by: Approval on File Frank Moschetto SQA Board Liaison

4 Page 4 of 5 Name: Company: GLP Attachment A: SQA CVIC Member Profile Job Title: Country: Your Regulatory Focus & Experience (Check all that apply) GMP GCP Part 11 / ERES FDA EPA ICH EU / EMA OECD MHRA GAMP Medical Devices Japan China / SFDA Other Other Relevant Experience (please indicate experience in ) Years of QA Auditing Experience Years of Computer Systems Validation Experience Years of IT Experience Your Commitment to the CVIC (Please record below how you intend to be active in the CVIC Answers ALL questions, Yes or No) a) I will attend either in person or remotely and actively participate in CVIC quarterly meetings b) I will volunteer to be a Liaison where appropriate and provide Liaison reports for the CVIC quarterly meetings c) I will write a CVIC article d) I will review a CVIC article e) I will write and give a presentation (e.g. at CVIC Training at the SQA Fall Meeting and/or SQA Annual Meeting) f) I will participate in the following subcommittee(s): 1. Training Committee 2. Innovation, Technical & Compliance Committee Note - You must enter Yes to (a) and at least one other from (b) (f). Skills you bring to the Committee Yes / No (Please summarize your skills and value to the CVIC)

5 Page 5 of 5 CVIC Membership Criteria: SQA Members only. 1. QA Professionals with Computer System Validation experience. 2. Members are expected to attend at least two quarterly meetings per year (physical or remote) and at least one of the activities from b to f above to meet membership requirements. 3. ACTIVE participation in CVIC activities is expected for continued membership (see commitment section above). 4. Dissemination of Information by the CVIC will only occur upon consensus of its members.