GMP Compliance: How Much Data Entry is Too Much?

If you are considering a GMP CMMS (Calibration and Maintenance Management System) for your company, there are many options out there ranging from logbooks to excel spreadsheet add-ons, to very sophisticated asset management systems.  It’s clear that some of the more basic methods (e.g. logbooks and spreadsheets) have their limitations, but what could be wrong with having one of the systems that can let you enter all the data points for your calibration/maintenance?  Some systems allow you to adjust intervals and theoretically save you a ton of money by reducing the amount of resources you need to put into your calibration/maintenance program.  This is a great thing, if you have a big enough equipment base to take advantage of it.

If you need GMP compliant Calibration Management, Validation Management, or Maintenance Management software, it is likely that the benefits of such a system will be outweighed by the costs.  Consider first that the requirement for GMP (and 21CFR11) compliance, eliminates some of the more reasonably priced systems.  Consider further the prospect of having to validate that the prediction algorithm is appropriate, or even figuring out what the algorithm is.  Additionally, there is significant  cost and effort required to enter the data to support the system.  And finally, this type of system has no obvious advantages from the point of view of compliance.  The exceptions, of course, would be for companies that have very complex systems that are expensive to calibrate and/or maintain, but this doesn’t reflect the position most small or medium FDA or EMEA regulated companies find themselves in.

Generally, FDA and EMEA regulated companies need GMP Calibration and Maintenance tracking software that helps them maintain compliance at a reasonable cost and with reasonable effort.  For example, compare the data entry time required for compliance in a simple gauge calibration versus entering the data for a full calibration.

Data entry required for compliance for a simple gauge calibrated at 5 points:

Data Entry

Required for Compliance

Full Data Entry (30 data points total additional work)
Data EnteredCalibration Date
Due Date
As Found Pass/Fail
As Left Pass/Fail
Traceable Certificate
Calibration Date
Due Date
5 Points As Found Data  (Standard Reading, UUT Reading, Calculated Difference)
As Found Pass/Fail
5 Points As Left Data (Standard Reading, UUT Reading, Calculated Difference)
As Left Pass/Fail
Traceable Certificate
Estimated Time for Entry1 minute5 minutes

Remember, this is for a simple gauge, that you would spend 5 times as much entering the data for no obvious compliance benefit.  This does not include time configuring for the input in the first place.  If you consider more complex examples (e.g.: multi-meters, balances, multi-variable sensors) the ratio is much higher, approaching 50:1 ratio or higher.  If you figure the average ratio with varying complexity of instruments to be 15:1 then for a mid-sized company with 1000 calibrated instruments, this can be the difference between occupying a person for 16 hours or 250 hours!  It is easy to see how this could add up, especially given the opportunity for errors in data entry.

Simplifying data entry could easily reduce your data entry by 90% with no significant impact on compliance!  Save yourself the headache and risk of data entry errors!

Assuming the calibration program is otherwise sound, the main objective of the scheduling software from a compliance perspective is to ensure that calibration is performed as scheduled, that the standards are traceable, and out of tolerance conditions are correctly managed.  From the above example it is clear that different approaches to data entry can significantly affect the resourcing that will be required to maintain compliance on an ongoing basis, even once the data entry systems have been set up.  Clearly, for leaner operations, tracking the overall pass/fail of calibration events is a more efficient manner of maintaining compliance with applicable regulations.