Using a Spreadsheet as Your Validated CMMS Software

spreadsheet as validated CMMS

Does it make sense to validate a spreadsheet for use as a CMMS system?

Often, a calibration or maintenance department will start out with a list of equipment that they keep track of on either a paper list, possibly a calendar, or a spreadsheet.  Spreadsheets have significant capabilities these days for organizing data and manipulating it to provide metrics and other useful information.  Also, spreadsheets can be programmed to automate some tasks with a little effort.  Finally, there is some ability to provide access control.  So, the question inevitably comes up:  Why do I need to buy something to do what I can do with my software?

The answer is, strictly speaking, there is no rule that says you can’t use a spreadsheet, or even a paper list, to track your calibration.  However, in a practical sense, the effort in maintaining current, accessible, and compliant records using a solely paper based or spreadsheet based system far exceeds the trouble and expense of getting a robust validated CMMS system.

The effort and expense of a paper or spreadsheet based system far exceeds the trouble and expense of a validated CMMS system.

Consider that any GMP system must be reliable, secure, and provide you easy access to the records you need in the event of an audit, or indeed, daily use.  It needs to be able to securely handle multiple users, with a robust audit trail.  Just these seemingly simple requirements, which don’t even consider the additional functionality you would like to have in a validated CMMS system, are difficult to achieve with a spreadsheet based system.  Consider that the CMMS should be installed on validated hardware, and the installation and any coded features need to be validated.  Then the system must be secured and provide an audit trail of all of the changes.  And appropriate reports need to be designed and validated.  This can be a months-long project to get the spreadsheet validated and secured on a validated server, and you still don’t even have direct access to the records.  What a nightmare!  Adding to that, in most spreadsheets it is easy to accidentally select the wrong cell to update or enter data in the wrong format.  Either of these could result in a missed calibration or other non-compliance.   Spreadsheets were not designed for this purpose.

For less effort and time, you can have access to SaaS based validated CMMS at a fraction of the cost and risk of a spreadsheet solution.

These days, a better solution is a validated SaaS CMMS system from a reputable company with experience in the industry.  With such a system, you pay a monthly fee, typically, and you have a system ready for GMP use almost immediately.  So you can be up and running with a validated system in less time than it would take to write the macros for your spreadsheet, let alone validate them.  And you will have a system that can provide quick access to your information in a presentable fashion.  No hardware to buy because it is a web based system.  Instead, leverage your time to research a system that has been designed from the ground up for use as a validated CMMS system with integrated 21CFR11 compliant audit trails by a reputable company with experience in regulated industries.

One final note:  If you decide to use a SaaS based system, keep in mind that you cannot validate a system that has not been designed as a validated system from the ground up.  There are many fine products for commercial use that were not designed as validated systems.  Any system you choose should have traceability to your requirements, and should have been designed and implemented in line with good practices as they apply to your industry.  Stay tuned for a future article about the pitfalls of attempting to validate a system retroactively.   Coming soon to a blog near you!

Avoid attempting to validate software not intended for GMP use, especially if you don’t have full control over it.