The 6 Most Common Problems in FDA Software Validation and Verification

Why Should You Attend:

This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards.

Areas Covered in the Webinar:

• Which data and systems are subject to 21 CFR Part 11 and Annex 11
• Why compliance makes good business sense.

• Details of FDA regulations/system features as applied to software: security, audit trails, electronic signatures.

• Requirements for local, SaaS, and cloud hosting

• The 6 Most Common Problems in FDA Software Validation & Verification.
• Strategies on how to avoid the most common problems.

• Advice on successful validation project staffing.

• Avoid 483 and Warning Letters

Frequently Asked Questions:

1. What are your thoughts on user involvement in writing test cases? Is it appropriate for a user to both write and execute test cases?
2. Do minor revisions need to be re-validated?
3. Please explain more on performance qualification - 10 step of CSV?
4. Definition of "Tester" in ISPE GAMP5 states that "testers should be as independent as possible. They should not be authors of the software, or of the test scripts if possible."
5. Can you do a quick summary from start to finish from a manufacturer installing software on a device that a customer will be using perspective?
6. Can we use third party to perform CSV instead of the user?
7. You mentioned that excel do not need to validation, I understand that is depending on excel function. Can you please elaborate on that. Why do we not need to validate the excels?
8. Can we use automated testing scripts to validate? Such as Test Rails used by IT?
9. Do you have recommendations for QA personnel to enforce CSV industry standard compliance considering the laws/regulations do not include instructions for how to comply?
10. Can you go over again why there is no traceability matrix needed for hazard analysis?
11. Where does QA reside....in IT department or Quality department?

Who Will Benefit:

• System owners - responsible for keeping individual systems in validation
• Computer system users
• QA / QC managers, executives and personnel
• IT / IS managers and personnel
• Validation specialists
• Software quality reviewers
• Consultants

David Nettleton
FDA Compliance Specialist, ComputerSystemValidation

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

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