If your spreadsheet supports any activity governed by applicable regulations, then it should be validated. Companies have been cited by FDA for not validating spreadsheets used for in-process analytical calculations, finished product analytical calculations, tracking and trendy quality metrics, and for their databases or lists. Major pharmaceutical, biologic, and medical device companies are not immune to these regulations, having received FDA warning letters in the past.
Here are a few commonly found errors:
- Spreadsheet files not maintained, some deleted
- Rounding errors
- Formulas don't match
- Conversion factors issues
- Spreadsheet doesn't show specs or limits
- Unclear documentation
- Security and data integrity issues
For Medical Devices, FDA’s 2015 Guidance on “Quality System Regulation Process Validation,” 21 CFR 820.70(i) focuses on automated processes to make sure that all software changes be validated before approval, and that validation activities and results be documented. With guidances such as these and others regarding biologics and pharmaceuticals, it can be hard to deduce what your laboratory needs to focus on, even when FDA does provide Lab Manuals of Quality Procedures.
Thankfully, here are a few pointers from our last Computer and Software Validation conference to help you validate your spreadsheets:
- Lock all non-input cells
- Make spreadsheets read-only, with password protection
- Automatically reject data outside valid ranges
- Test by entering expected and extreme values, and nonsensical data
- Keep record of all cell formulas
- Document changes made to the spreadsheet
- Change control with version numbers
- Re-validate spreadsheets periodically, including cell formula verification and manual verification of spreadsheet calculations
For more information on validating your spreadsheet for FDA readiness, attend IVT Network’s 18th Annual Computer and Software Validation on April 25-27, 2017 in San Diego, CA. You can also download our e-book that digs into computer system compliance.