Regulatory Challenges of Importing Data Into Your Validated CMMS System

Picture the scene:  you have a validated CMMS (Calibration and Maintenance Management Software) system.  You may have selected GxPReady! Suite, so you are up and running in a week or two, fully validated.  So, now you just run your import script, and voila!  you will have a fully validated system right?  Well, in reality, it depends…

We often get the question of whether data can be imported and exported from the GxPReady! Suite database.  The answer, as with most databases, is “yes”.  But the challenge is often no the actual ability to import data.  Often it is ensuring that the data have been appropriately reviewed and formatted and the manner in which these activities are documented.  Any data that are entered into a validated CMMS system should be reviewed/approved by qualified personnel prior to (or during) data entry.  It is not acceptable to simply import data from a spreadsheet that has not been reviewed in detail.  It is also recommended that this review be documented in your hard copy files (or scanned documents) as well as in the database itself.  So there are challenges beyond the technical ability to import data.

Below are some of the steps we often help our customers through to make sure they get the most value from their GxPReady! Suite deployment:

  1. Ensure that they have a great turnover package and procedures in place for use of the software.  These include receipt and managing the life cycle for equipment, setting up schedules, calibration tolerances, etc.
  2. Work with them to ensure that they have forms in place to document the collection and approval of data for new equipment; calibration, validation, and maintenance activities; and the schedules for these activities.
  3. Set a system to document that any information is reviewed and approved prior to data entry and that data are accurately entered.
  4. Provide administrative support as necessary to assist in the transition from the current system in use.  This is often a transition from spreadsheets, a non-validatable system, or hard copy calendars.
  5. Provide ongoing support, working with their QA personnel and systems, to maximize compliance.

Each customer is unique and has their own strengths.  In the end, data importing and management is a team effort between the customer and the provider.  Likewise, the long term compliance requires compatibility between the procedures of the customer, the activities performed, and the administration of the validated CMMS system.  GxPReady! provides significant support services at no additional cost beyond the low software use fees and more extensive support on a case by case basis to help our customers maintain a high level of compliance.  We can work with you group to set up an efficient, simple, and compliant calibration, maintenance, and/or validation program that meets your needs.