The Clinical Device Group presented an e‑conference How to Make Excel Part 11 Compliant on February 4, 2009 at 11:00 am Central. The e‑conference was presented by Mr. Derek Wimmer.
This conference has already occurred. Please contact Ofni Systems if you would be interested in setting up your own training session on MS Excel and Part 11 Compliance.
Learning Objective
In this e-conference you will learn how to make your Excel applications Part 11 compliant.
Compliance is Important
Microsoft Excel is the most popular choice for handling clinical data, but it also raises the most questions when it comes to computer validation.
Excel spreadsheets are used for many things in clinical research, but the use of the spreadsheets is not typically validated. What validation means in the context of a spreadsheet isn't well defined, and which spreadsheets need to be validated depends on what you’re doing with them. Part 11 and the FDA’s actions with that rule have caused a lot of doubt, fear, and uncertainty.
FDA considers validation important and has issued guidance on Computerized Systems Used in Clinical Investigations. Validation of Excel spreadsheets and compliance with Part 11 need to be addressed
Addressing Validation
Mr. Derek Wimmer will address 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. He 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
Case studies and resources will be provided for reference.
You will Receive
All people who attend this e-conference will receive:
- PowerPoint Slides
- An expert speaker
- A chance for Q&A
- CEUs & Certificate
Audience Suitability
This e-conference is suitable for:
- Clinical research professionals
- Managers who sign-off on clinical trials
- Quality Assurance professionals
- Managers and staff who are responsible for providing valid data
- Information Technology professionals who work in the clinical trials industry
Special Offer from Ofni Systems
Ofni Systems will provide all conference attendees with a free trial copy of ExcelSafe. ExcelSafe provides security and compliance features for MS Excel spreadsheets, including audit trails, password protection and electronic signatures. ExcelSafe also provides tools to manage spreadsheet data.
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