How to Validate Device and Computer Software

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Computer software validation has been a major issue for medical device manufacturers and is one of the leading causes of 483 observations, warning letters and product recalls. There are many different types of computer hardware and software found in the medical device industry, including:

  • COTS (Commercial Off-The-Shelf) applications
  • Custom in-house applications (databases and spreadsheets, web apps, etc)
  • Software embedded in medical devices
  • Software used to create or manufacture devices

All of the above must be validated for intended use and be under strict change control.  The risk to patients can be severe for even small software bugs, and the cost of legal actions or product recalls can be financially devastating. The following topics will be covered in detail:

  • A review of recent enforcement actions as a result of inappropriate computer system validations.
  • The basics of computer software validation and what is expected in any validation effort.
  • A presentation of Ofni System’s methodology for how we create functional requirements, design specifications and test cases.
  • Education for users about specific hot spots, including Change Control and Risk Assessments.
  • A discussion of new technologies for automated testing and electronic protocol execution.

e-Conference, Presented by the Clinical Device Group

21 CFR Part 11 Compliance and Validation for MS Access Databases – 2/18/2009

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Mr. Tyson Mew will address validation and 21 CFR 11 with regard to usage of Access databases. By properly securing your databases, you can allow a much wider audience to use and benefit from every database within the organization. The following topics will be covered in detail:

  • How to add audit trails to any part of the database
  • How to properly secure the data and code
  • Access database security settings for multiple users
  • Common settings to apply to limit user actions
  • Learn what the FDA will look for during audits
  • Managing change control and common mistakes to avoid
  • Details on when and where to use Electronic Signatures
  • Database testing and techniques for software validation

Attendees will receive instructions for how to apply controls to their own access programs.  In additions, attendees may download sample code and validation documents for their own use.

February 18, 2009
e-Conference, Presented by the Clinical Device Group

How to Make Excel Part 11 Compliant

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This conference addressed validation and part 11 with regard to your usage of Excel spreadsheets. You will learn what your options are and how to address the issues for the different categories of spreadsheets use. Tyson Mew will address:

  • What Excel is used for
  • Different categories of spreadsheets
  • Relevant regulations and history
  • Excel’s lack of compliance features
  • Where we are today with respect to Part 11 and enforcement
  • Options available to address Excel’s shortfalls
  • Applying those options to the different categories of spreadsheets
  • Managing the whole process
  • How to approach the issue if it’s an emergency and you have no money/time/resources

e-Conference, Presented by the Clinical Device Group