Computer System Validation (CSV)

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 What is Computer System Validation?

Companies, particularly the life science industries must validate their information technologies (such as computer systems, software that run on them and infrastructure components) to ensure they meet the intended business needs. Computer System Validations involve activities primarily around generating requirements and specification documents, testing the systems against those specifications, documenting test results and writing final reports.

  • Information Technology Application fulfils its intended purposes
  • Formalized Process: Plan à Execute à Summarize
  • Documented evidence
  • Unit, Integration, UAT, IQ, OQ, PQ, Configuration and Migration testing
  • Risk-based management and testing
  • Applying controls and procedures
  • Good software engineering practice in a formal setting

 

Course Benefits:

  • Gained a good overview of all the key processes
  • Learned best practices key validation documentation
  • Developed a conceptual/practical approach to solve “real-life” problems
  • Familiarized with key regulations – able to speak the “language”

 

Who Should Attend:

This course benefits anyone that currently uses (or in the past) computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.  Here is a list of professions that might find the class helpful:

  • IT professionals
  • Software Vendors and Developers
  • Research, Development and Manufacturing associates and scientists
  • Healthcare and clinical professionals
  • Quality Management professionals (QA,QC, Regulatory)
  • Technical Project Managers
  • Additionally people who are already employed in this field can learn proven techniques to find various efficiencies in their existing processes without weakening quality positions.  Upper management professionals can find useful information to learn how to design, build and implement a compliant Computer System Validation program in your respective operation.

 

About the Instructor:

  • Background
      • QA/QC
      • Scientific Data Systems
      • IT System Implementation and Validation
      • Education – M.S. and MIS
  • Professional Experience:
      • Bayer Pharmaceuticals (Senior Manager, Information Systems)
      • IDBS (Senior Consultant)
      • Gilead Sciences (Senior Manager, IT Quality and Compliance)

 

The Career Outlook

Computer System Validation field had enjoyed an explosive growth since the early 90’s.  In US, there are estimated 20,000+ such professionals dedicated to this field and the need is steadily growing as technology evolves and regulations increase.  It’s a relatively new discipline and a practical science therefore, institutional (i.e. collegiate) educational programs are scarce and people rely on vocational training programs to get educated. 

A majority of the life science companies use contractor/consultant resources to cover the staffing required to support the compliant Computer System Validation program. In the Bay Area alone, the need for Computer Validation related contract positions is greater than perhaps several thousands and is still growing.  There are lots of benefits working as a validation contractor such as high pay, flexible schedules, working from home and potentially becoming full time employed.

In order to become successful in this field, preferably you should have collegiate education in either life science (Chemistry, Biology and etc) or computer science particularly database technologies and programming.  You will need to be quality minded and meticulous and thorough when it comes to documentation and testing.

 

Course Dates: 24 hours (pls call for details)

 

Course Content

Topics to be covered:

  • Definition, Drivers and Benefits
  • Computer System Validation activities Typical documentations and deliverables involved in a CSV project
  • A closer look at Validation Plan, URS, FRS, DS, IQ, OQ and PQ
  • Key elements of a good documentation system to support CSV compliance
  • Use Case # 1: How to set up validation processes to support critical businesses
  • Use Case # 2: How to validate and implement a new enterprise software application
  • Use Case # 3: How to validate a major system upgrade and data migration
  • Special Topic # 1: Part 11 – does it apply to you?
  • Special Topic # 2: Effective management of deviations during validation
  • Special Topic # 3: A risk-based approach to compliant GxP computerized system validation
  • Special Topic # 4: Ongoing system maintenance and change management
  • Special Topic # 5: Recent regulatory trends and SaaS/Cloud validation


Class Format

  • Interactive; Q&A’s; Real-life scenarios
  • Minimal homework, mostly reading and classroom exercises