How to Buy COTS Software, and Audit and Validate Vendors

Instructor: David Nettleton
Product ID: 703820
  • Duration: 90 Min
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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:

Computer System Validation’s principal, David Nettleton, is an industry leader, author, and instructor on topics pertaining to 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 250 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.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
21 CFR Part 11 Compliance for SaaS/Cloud Applications - 80202SEM

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