Specialty Sections

Participation in SQA Specialty Sections is open to all SQA members. Specialty Sections are a vital part of what the Society does. They provide discussion on specialties within the QA profession, organize sessions at the SQA Annual Meeting, communicate via listserv, publish technical papers on current topics and more.

 

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Computer Validation & Information technology Compliance Specialty Section (CVIC-SS)

Welcome to the CVIC webpage on computer system validation & IT compliance. Computerized system validation and IT compliance is an ever evolving activity and the CVIC’s primary purpose is to disseminate current and applicable information to Society members.

CVIC membership is open to any SQA member in good standing. We encourage active participation for CVIC members and request that each member join one or more of the specialty subcommittees listed below. For more information please contact the CVIC-SS Chair or a current member.

Mission Statement

It is the mission of the CVIC to provide the Society with best practices to maintain compliance of computer systems and related technologies in accordance with applicable laws, regulations, directives, and guidelines.

History of CVIC

The SQA Computer Validation Initiative Committee (CVIC) was initiated in July of 1996 as an ad hoc committee to provide current industry perspectives on computer validation issues for the QA professional. Today, it has grown in interest, size and standing.

In January of 2018 the CVIC was "rebranded" as the Computer Validation & IT Compliance Specialty Section to include a broader scope, including but not limited to: information/cyber security, vendor management, data protection, data integrity, development of data standards (such as SEND), governance risk & compliance, electronic records, business continuity, records management, data centers, infrastructure, mobile apps, and artificial intelligence. Our underlying focus regarding computer system development, testing, implementation, maintenance, and decommissioning has not changed, but rather is incorporated into this broader scope.

The "new" CVIC consists of several subcommittees, including:

  •          Training
  •          Data Integrity & Governance (DIG)
  •          Audits & Vendor Assessments (AVA)

CVIC welcomes all Society members, irrespective of their experience and would be pleased if they can participate in any way they can.

The CVIC has been a very active Specialty Section, and member participation has been a hallmark of our success. Many CVIC members volunteer significant time and talent on the development of training modules for the CVIC computer validation training sessions, annual meetings, developing articles to be published in SQA newsletters, preparing/presenting webinars to members, or interfacing with regulators or other organizations on computer validation and Part 11 issues. The Committee also disseminates information to the members via newsletters, the SQA website, and roundtable discussions.

If you are interested in participating in the CVIC Specialty Section, please click on the ‘Join a Specialty Section’ link at the top of this page.

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