Validation Plans

Getting Started with Validation –
What To Validate, When to Validate, How to Prove You Validated It – 11/15/2012

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Getting started with computer validation can seem like an expensive and impossible task. Too often, organizations only perform validations as a reaction to observations, validating systems one by one. Even if this addresses the immediate observation, the next audit reveals yet another system that is out of compliance creating a history of non-compliance. One of the secrets of computer system compliance is that a well-controlled compliance program adds value to your organization. While validation may seem like a cost, an efficient validation program enhances the value your organization by improving quality to your suppliers, reducing business and regulatory risks, and supporting the training and administration required to allow your organization to grow and thrive.

Attendees will learn the following:

  • Which out your computer systems need to be validated… and which do not.
  • The documentation FDA auditors expect to demonstrate your computer systems have been validated and are operating in a compliant manner.
  • The differences between validation, qualification, user acceptance testing, and internal quality, and when each is appropriate.
  • The regulations that your computer systems must comply with, and the procedures that document that compliance.
  • The procedures required to ensure compliance with 21 CFR 11 and Annex 11.
  • What to ask for when purchasing computer systems that will be used in GxP environments.
  • Industry best practices to maximize your validation resources.
  • How to bring System Owners, Users, and Quality together to improve your business..

On Thursday, November 15, 2012 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about desktop database compliance and validation, including specific, practical advice on creating compliant desktop databases, validation methodology, and maintaining desktop databases in GxP environments.

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit