How to Buy COTS Software, and Audit and Validate Vendors

Instructor: David Nettleton
Product ID: 703820
  • 13
  • April 2017
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 90 Min

Live Online Training
April 13, Thursday 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Min

One Dial-in One Attendee
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Customer Care

Fax: +1-650-565-8542


Read Frequently Asked Questions

This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.

Why Should You Attend:

This webinar will provide the process steps to:

  • Buy Commercial Off-The-Shelf (COTS) software
  • Evaluate software vendors
  • Validate for 21 CFR Part 11 compliance

It will detail the SOPs, product features, and developer validation documentation requirements for auditing software vendors. It will demystify the requirements for software-as-a-service (SaaS) and cloud computing. Attendees will learn how to efficiently validate COTS software, and understand how to use change control to keep the validation status current.

Areas Covered in the Webinar:

  • How to buy COTS software
  • How to evaluate a software vendor
  • Which data and systems are subject to Part 11
  • Avoid 483 and Warning Letters
  • Learn the requirements for IT, SaaS, and cloud hosting
  • Understand the current computer system industry standards for security, data transfer, audit trails, and electronic signatures
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software

Who Will Benefit:

  • Computer system users
  • IT department
  • QC, QA
  • Managers and executives
Instructor Profile:
David Nettleton

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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