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
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.
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:
& Governance (DIG)
Vendor Assessments (AVA)
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.