Product Details
Effectively storing, manipulating, analyzing and reporting data is critical to any successful drug or device development effort. To do so, you turn to digital data analytics tools, like Excel spreadsheets, and you will need those spreadsheets to be validated by the FDA.
With this updated Spreadsheet Validation management report, you’ll discover how to move a spreadsheet toward validation with the FDA, determining the best ways to conform with data integrity requirements and uncovering what FDA inspectors are looking for in a validated data analysis and reporting tool.
Beyond a rundown of validation basics, compliance and computer system validation expert David Harrison has included more specific details, including information on files without formulas, the requirements for embedded spreadsheets and the frequency with which an organization must validate its spreadsheets.
This updated management report covers:
- How Excel spreadsheets and their use must be validated by the FDA and what the agency expects from validated spreadsheets
- The FDA guidelines for developing and implementing an efficient, compliant and repeatable process for validation
- Incorporating spreadsheet validation into overall quality assurance and validation procedures
- Ways data storage and cloud storage impact spreadsheet validity
- Appropriate workflow options for planning a validation project
- Tips for testing spreadsheets and the macros used in them and for determining what level of detail the tests should produce
- How and when third-party software features may be used to boost data security and establish audit trails
- The deliverables a validation project should produce
- The need to validate spreadsheets embedded in a validated software system
- The expected frequency of validations and how to deal with the often-changing Microsoft Office program
All the information you need to avoid FDA compliance enforcement actions, ensure your spreadsheets are validated and create FDA-approved processes for data manipulation, storage, analysis and reporting is in Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant.
Order your copy today and start your path toward an effective and efficient validation process.
David Harrison, a principal consultant with CSV Compliance, specializes in pharmaceutical and life sciences compliance and computer system validation. He has managed the introduction and implementation of 21 CFR Part 11 and computerized system validation products for multiple blue-chip clients, including more than 400 spreadsheet validation projects. Harrison has worked in various quality assurance and consultancy roles in the drug, biotech and device industries.
About the Contributor
David Harrison, a principal consultant with CSV Compliance, specializes in pharmaceutical and life sciences compliance and computer system validation. He has managed the introduction and implementation of 21 CFR Part 11 and computerized system validation products for multiple blue-chip clients, including more than 400 spreadsheet validation projects. Harrison has worked in various quality assurance and consultancy roles in the drug, biotech and device industries.
Who Will Benefit
- Drugmakers and devicemakers
- API manufacturers
- Distributors
- Clinical trial professionals
- QA and QC specialists
- Validation specialists and engineers
- Clinical research directors and manufacturers
- Compliance officers
- Data management and statistics personnel
- R&D staff
- Study monitors and coordinators
- Financial accountants and auditors
- Compliance personnel who use spreadsheets
Add to Cart
Contributor:
David Harrison
ISBN-13:
978-1-60430-153-3
Publication date:
Nov. 9, 2020
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