SQA Computer Validation Initiative Committee CVIC

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SQA Computer Validation Initiative Committee
(CVIC)

• Michael A. Maddix, Audit Manager, Wyeth Research
• and
• Drew Finnie, Systems Manager, McDougall
  Scientific Ltd.

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Why is there a need for computer validation
resources?

• FDA Inspection Issues Raised
• Lack of SOPs
• Requirements and Design Specification
• Programming and Testing
• Integration and Validation Testing
• Vendor
• Change Control
• QAU involvement
• Data Security
• Data Archival

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Computer Validation Initiative Committee
(SQA Specialty Section)Goals

• Educate and Train the SQA membership
• Training at the SQA annual meeting
• Training at the half-year education weeks
• Interactive Workshops
• Computer Validation Sessions at SQA meetings
• SQA members are always welcome to email questions
  to the committee for consideration and answers.  
• Articles are published in the SQA newsletter, so
  they are available to the membership.  

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History of the Committee

• Originated at SQA meeting 1995
• First meeting was held July 1996
• (participants volunteered)

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SQA CVIC
Vision

• To focus on the development, promotion, and
  dissemination of information, ideas, and
  standards surrounding the global regulatory
  requirements of computer system development,
  test, implementation, maintenance, and
  decommissioning.

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SQA CVIC Mission

• Identify issues submitted by SQA members
  researched responses, and publish results or post
  the information in our website. (www.sqa.org)
• Stay informed and maintain awareness of current
  industry, government, academia, and technical
  trends.
• Develop computer validation training that is
  current, up to date, and relevant for the Quality
  Assurance Professional.
• Interact and influence regulatory guidance,
  standards and rules to reflect good practices in
  computer validation.
• Communicate to the SQA Membership about CVIC
  activities through articles, presentations,
  question and answer sessions, and workshops.
• Proactively partner with other SQA committees.
• Keep information on the web page current and
  develop an archive of previously published
  information.

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What CVIC can do for you?

• Provide a Forum for Discussion -The CVIC
  committee is a captive and knowledgeable audience
  to discuss your current computer validation
  issues.
• Excellent Networking Opportunity -The greater
  your involvement in the committee, the greater
  number of networking opportunities you will have.
• Peer Group for Publications - CVIC provides a
  pool of expertise for you to draw from when
  working on or proposing your own manuscript for
  publication.
• Get the Latest Information as Soon as it is
  Available-Through Liaison Activities. CVIC
  members are privy to the most current computer
  validation news.
• Direct contact with FDA Health Canada computer
  validation representatives to answer questions.

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What you can do for CVIC?

• Get Involved! - If you have experience dealing
  with computer validation issues in your current
  job, pick up a CVIC membership application and
  start sharing your experiences with the rest of
  the committee.
• Serve as A Liaison - CVIC strives to reach out
  and interact with as many related outside groups
  and committees, regulatory agencies, and other
  SQA specialty sections as possible. Volunteer to
  serve as a liaison to CVIC from your group and
  help us to stay informed.
• Volunteer to Serve on A Subcommittee - Once
  youre a member of the CVIC, you have the
  opportunity to use your strengths to help us
  communicate with the SQA membership at large
  through writing articles for publication,
  presenting training sessions, leading the CVIC
  sponsored Open Forum, and participating in lively
  discussions.

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What has CVIC done for you?

• Training Workshops Prepared
• and Presented by CVIC (Part 1)
• Introduction to Computer Validation
• Where is it Written?
• Risk Assessment
• System Development Life Cycle
• Planning the Audit
• Conducting the Audit
• Documenting the Audit
• Maintaining the Validated State

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What has CVIC done for you?(contd)

• Training Workshops Prepared
• and Presented by CVIC (Part 2)
• System Maintenance (Change and Configuration
  Management)
• Testing
• Security
• Advanced Regulatory Issues
• SQA Annual Meeting Sessions
• Regional Chapter Meeting Sessions

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What has CVIC done for you?(contd)

• Questions submitted to the CVIC. Answers to be
  posted on the SQA website.
• What is the process of validation of equipment
  (e.g. hospital) used in support of a GLP or
  non-clinical study? I.e., The equipment used
  (Ultrasound machines, fluoro equipment etc) is
  already used in clinical or hospital settings but
  because it is part of FDA/GLP regulated studies
  we are expected to follow the same rules for
  validation part 11. The problem is that no one
  has really defined or said to what extent those
  rules apply exactly how they should be
  followed.
• How much testing is enough for upgrades? Points
  to consider for system changes.
• What is necessary to successfully validate off
  the self applications? Points to consider for
  commercially available software.
• The advantages and disadvantages of purchasing
  vendor test scripts to conduct your user
  acceptance testing?
• What techniques and procedures are available to
  prove execution of expected results?

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Interested in Becominga CVIC Member?

• Beneficial if candidates have had actual computer
  validation experience
• All members must participate
• Contact CVIC member or chair to submit an
  application profile
• Quarterly meetings held at the same time as the
  Regulatory Forum, in the Baltimore area and in
  conjunction with the SQA Annual Meetings.
• Members participate and contribute.

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Canadian (CCSQA) Representation on the CVIC

• Drew Finnie, Systems Manager, McDougall
  Scientific Ltd.
• Ms. Laiwa Cheung, CANTEST Ltd.
• Michael A. Maddix, Wyeth Research

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