6 Most common problems in FDA Software Validation and Verification

Stacey Bruzzese welcomes David Nettleton to the show. Today, Stacey and David will discuss the 6 most common problems in FDA validation and verification.

David 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 290 mission critical laboratory, clinical, and manufacturing software implementation projects, and has written 5 books on CSV subject matter.

Topics Discussed:

An explanation of what CSV entails and why it’s so important in highly regulated industries…

Understanding 21 CFR Part 11 regulation and guidance, and the confusion it often creates for many companies…

6 Common Problems:

1 - required systems

2 - software requirements

3 - other resources that can be insufficient or inappropriate

4 - vendor responsibilities

5 - Traceability is a HUGE factor in terms of FDA expectations during audits

6 – the lack of appropriate SOPs

David Nettleton, and co-author Janet Clough, recently released a new technical book Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates a systematic, step-by-step approach for validating configurable off-the-shelf software that generates data or controls information about products and processes subject to regulations. With the purchase of this useful guide you will also receive access to templates the authors have used as training tools for more than 1,000 companies and components of more than 300 validation projects. David is also the author of the following books which can be purchased through the PDA bookstore, or by clicking the links below:

1. Risk-Based Software Validation-Ten Easy Steps (Out of Stock)

2. Managing the Documentation Maze

3. Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

4. Commercial Off the Shelf Software Validation for 21 CFR Part 11 Compliance (Out of Stock)

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