Can I use Excel or my Other Favorite Spreadsheet as my Validated CMMS?

Calibration and Maintenance management systems (CMMS) are expensive and take significant resources to select, install, and validate.  Understandably, managers of calibration and maintenance departments of growing companies focus on the work at hand and often use the resources available to manage their operations as well as possible.  These can range from paper lists, to card systems, to logbooks, and/or spreadsheets.

Clearly, paper systems do not require “validation” per se, but can be managed using training, so long as the systems that are tracked can be well supported in compliance with applicable calibration and maintenance program written and approved standard operating procedures.  However, as the list of items approaches triple digits, the maintenance of a paper only scheduling system can become cumbersome and prone to error.

The next step, in many cases, is to move to spreadsheets, using macros to help clarify which items are due for calibration and/or maintenance.   These have obvious advantages of convenience due to the ability to sort by departments, owners, due dates, etc.  In this manner, managers can generate lists to better handle operations.   Spreadsheets can acceptably manage more items than can easily be managed with paper based systems, but for GxP compliance, spreadsheets should be validated.  In addition, changes to spreadsheets should be tracked in compliance with 21CFR11 requirements, including tracking the person that made the change, the reason for the change, the pre and post values, and an identification of the person making the change.

Meeting GxP requirements for a scheduling spreadsheet therefore requires all of the typical major steps of a system validation:

  • User Requirements
  • System Specifications
  • Coding
  • Deployment on Qualified Hardware
  • Acceptance Testing
  • Validation Testing
  • Operation per Written/Approved SOPs
  • Maintenance of Change Control/Security/Backups
  • Ongoing IT Maintenance

So, the answer posed to the question in the title is “Yes”, a spreadsheet can work as a validated CMMS, if the system is validated and maintained in compliant manner per the company Validation Master Plan (VMP).

Suddenly, this starts looking like a major project to keep up with the success of your company as it advances toward manufacturing through the GxP process.  Beyond that, at this point, the validation sometimes becomes a retrospective activity, because the spreadsheet that has worked so well for some time only now requires validation.  So now, as an area manager,  you have to worry about validating something already implemented, and catching up on all that documentation, while keeping up with the growing company.

Having been in this very situation, I know that macros and visual basic can go a long way in addressing some of the challenges posed by GxP requirements.  And, to be honest, it is a tempting proposition.  However, also from experience, I can attest to some of the very real limitations of spreadsheets in GxP environments supporting calibration, validation, and/or maintenance scheduling:

  • Managing multiple users with assorted privileges can be very challenging.
  • Change tracking with the various 21CFR11 requirements is very difficult while maintaining easy usability.
  • Reports generated using spreadsheets can be difficult to manage.
  • Tracking of changes to the revision of the spreadsheet(s) can be difficult to manage on its own.
  • It is difficult to add capabilities to spreadsheets due to change control requirements for validated systems.
  • Controlling data entry to prevent accidental overwrites is difficult.
  • Tracking deviations, out of tolerance conditions, and other exceptions is difficult.
  • Everything takes more time and costs more than you expect.
  • The coding performed is difficult to annotate and make clear in its purpose, which makes it hard to maintain.
  • Usually, you have to get your regular duties done while you are trying to do this at the same time!

Often, the result is that despite great effort and intention, it is very difficult to get a quality, sustainable solution using spreadsheets for this application.  Although it may serve as a stopgap validated CMMS system, even when perfected, it becomes increasingly unmanageable as the equipment list begins approaching mid triple digits.

However, if you are using a spreadsheet as a scheduling tool for your calibration, validation, and/or maintenance management system it is likely that you can still use this data to import to a validated CMMS, such as GxPReady Suite.  In this way, you gain the benefit of the work you have already done, and with virtually no delay, you save yourself the headaches of trying to qualify a legacy system, and you are suddenly compliant with GxP requirements, including 21CFR11!  At the same time, you can generate convenient forms and reports, and easily handle multiple user access.  Sounds like you deserve a raise!