The Right Tool for the Job – Validated CMMS Systems

evaluate your CMMS software for the long run

The CMMS system you are currently using may have served you well, but is it ready for GMP work?

A higher level of competition sometimes requires an upgrade of the equipment you use to compete.  This is true in virtually every endeavour and is no different when gearing up for GMP compliance.  Just like your favorite shoes may not have made the grade for the track team, your current maintenance and calibration tracking system may not be up to the task for compliance with FDA and EMEA requirements or may be to cumbersome to give you easy access to information that you really would like to have at your fingertips.  The following are some systems smaller and growing companies may have in place for managing their calibration and maintenance that might present challenges to GMP compliance:

  • MBWA (Management by walking around) – In this method, the calibration or maintenance manager performs periodic walkthroughs or email campaigns to determine what equipment is due for service.  Each person is responsible to track and keep records for their equipment.  In a regulated environment this has obvious drawbacks due to the decentralized control of documentation and scheduling and the likelihood that items can be missed.  Any GMP audit will likely identify equipment that has not been serviced, missing records, and inconsistent enforcement of tolerances, intervals, reviews, and quality standards.
  • Calendar/Logbook – In this method, paper records are used to track scheduling and completion of calibration and maintenance.  When supported by appropriate SOPs this can be effective for a small number of equipment items, but quickly becomes more burdensome as growth occurs.  Continued growth significantly increases the difficulty in maintaining and ability to locate records.
  • Spreadsheets – Spreadsheets can be used to manage calibration and maintenance scheduling, but as soon as you transition to an electronic system, additional qualification requirements apply to your solution, including computer system validation and 21CFR11/Annex 11 requirements.  Furthermore, security and change control are difficult to manage with spreadsheets in a manner that work history and audit trails are available for review.  Multi-user access can also be a problem for these systems.

The right system for compliance is a validated CMMS system that fits your needs at a reasonable cost.  Any such system should meet basic requirements for compliance including:

  1. The system should be designed from ground up and validated to meet regulatory requirements, including 21CFR11 with solid security and audit trails.  The quality should be designed into the system for maximum reliability.
  2. The system should be specifically designed for the intended use of CMMS management.
  3. Ease of use should be designed into the system to reduce the opportunity for errors and discrepancies in data entry.  Excessive data entry requirements can create backlogs and/or lead to unnecessary data entry errors.
  4. You should have the ability to easily retrieve records for review.  Even if you maintain hardcopy files, it is useful to be able to access records quickly on line during an audit or everyday operations.
  5. If the system is provided as a service (e.g. via the internet), the hardware and infrastructure should be validated to ensure appropriate controls are in place over the whole system.  Do you know where the servers are?  Are they validated?  Who controls them?
  6. The costs should be well understood.  Some validated CMMS systems have significant extra charges for features that you would expect to be included (e.g. updates, user licenses, etc)

The cost of validated CMMS systems has recently been reduced with on-line alternatives.  These systems can provide you flexibility and low cost so that you can save resources for your core business functionality of getting product out the door.

The validated CMMS landscape has evolved from the old standard of in-house installations to more on-line SaaS systems.  Make sure the system you choose meets the needs for your new regulatory requirements and keep your company competitive without breaking the bank!