Validation and Use of Excel® Spreadsheets in Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® the requirements can be met. This seminar will demonstrate how requirements will be met.
Areas Covered in the seminar:
- FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
- How to design spreadsheets for part 11/GxP/SOS/HIPAA compliance.
- Validation during design, development, installation and on-going use.
- When, what and how much to test?
- How to handle standard Excel functions?
- How to ensure and validate spreadsheet integrity for GxP and part 11?
- How to apply risk based validation to spreadsheet applications.
- Validation of 'ad hoc' spreadsheet applications.
- How to ensure spreadsheet security and integrity.
- How to document planning, specifications, installation, testing and changes.
For easy implementation, Attendees will receive:
- SOP: Validation of spreadsheet applications
- SOP: Development and use of spreadsheets in regulated environments
- Gap analysis/checklist for Macros and Spreadsheet applications
Who will benefit:
- Pharmaceutical and medical device industry
- All developers and users of spreadsheet applications
- Validation specialists
- QA managers and personnel
- Regulatory affairs
- Production and lab managers
- Training department
- Documentation department
- Consultants
Instructor Profile:
Ludwig Huber, Ph.D., is chief advisor for Labcompliance and Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press. For more information, visit Dr. Huber’s website: www.ludwig-huber.com
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