Engaged. Knowledge. Application
Auditing Computer-Related Validations CONTENT Package
Package includes a webinar recording with powerpoint presentation, two articles and a checklist:
➢ 1.Computer Validation Audits: A Primer for Successful Execution (One Hour Webinar Recording)
➢ 2.Computer Validation Audits: A Primer for Successful Execution (PowerPoint Training Presentation)
Click here to view complimentary excerpt
➢ 3 Regulatory Documents Explained: The Basics (Article)
➢ 4. and 5. Spreadsheet Validation: Critical Considerations (Article and Checklist)
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to view complimentary excerpt
1.and 2. Computer Validation Audits: A Primer for Successful Execution (One Hour Webinar Recording and PowerPoint Training Presentation)
Click here to view complimentary excerpt
Eric Henry, former Sr. Manager, Corporate Software Quality, Boston Scientific, reviews the following subject matter content in this one hour long webinar:
➢ Software validation in an FDA-regulated company
➢ What do I want to know?
➢ Can just anyone perform an audit?
➢ What do I audit?
➢ The pre-review
➢ In the room Q&A, roles & tips, the players
➢ What do I say about what I saw?
➢ Addressing the findings (…or damage control)
3. Regulatory Documents Explained: The Basics (Article)
Basic types of regulatory documents are defined related to matters of quality assurance and computer validation in this 14-page article. The author attempts to characterize their anatomy, structure, organization and content, so they may be better understood by those who use them.
The following subject matter is reviewed. A number of charts/examples are utilized throughout the article to further understanding:
➢ Four Basic Document Types
-Statement Documents
-Process-Related Documents
-Work Products
-Supporting Documents
➢ Policies
➢ Acceptable use policy
➢ Interpretations and rationale
➢ Procedures
➢ Work instructions
➢ Detailed forms and templates
➢ Guidelines
➢ Standards
➢ Regulations
4. and 5. Spreadsheet Validation: Critical Considerations (Article and Checklist)
Click here
to view complimentary excerpt
This article provides specific areas of consideration and useful tips for conducting a spreadsheet validation. Areas reviewed include:
➢Scoping (a list of 21 questions to ask)
➢Risk assessment
➢Standards
➢Validation process flow (chart included)
➢Requirements
➢Development
➢IQ/OQ/PQ
➢Version control for development
➢Change control
A generic controlled document checklist for spreadsheet validation is included.
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