Key Features to Look for in a validated CMMS as Part of Your Asset Management Program

Image showing a the concept of a validated CMMS, with emphasis on its security.

This article identifies some key features to look for in your validated CMMS

There are several key features you should look for in a validated CMMS to support your ongoing asset management program.

CMMS software can solve many of the issues you may be having with your paper or spreadsheet-based systems. Use a CMMS to store and find information related to your calibration and maintenance requirements and the work performed. It also provides a schedule of work  yet to be performed, without scanning through reams of paper or lines of spreadsheet records that may or not be secure.

In the case of CMMS systems for biotech and medical device companies, compliance is a major factor. It is difficult, and usually impractical, to try to qualify a system that was not designed for GMP compliance because much of the work that is required for qualification of software is performed during the development process, before the software is even deployed.

Look for the following features in a CMMS system for biotech/pharma or medical device companies:

Compliance
  • Take a look at whether it really is designed for compliance with 21CFR11 and/or Annex 11 with supporting documentation.
  • Confirm that human readable change tracking is accessible.  Addition and changes to any record should be clearly documented, require verification of the person making the changes, the changes made, and the time/date of the change.
  • Verify that  the system was designed for GMP use.  The software development life cycle (SDLC) is a key component of compliance.
Security
  • Look for System security  to provide each user with a unique username/password combinationa. Avoid use of group passwords that do not identify the individual users. User access should be tailored to the requirements of their job functions.
  • Check if record locking is provided to prevent multiple users from being able to edit the same record simultaneously.
Reporting
  • Verify scheduling reports are available to identify equipment that is due in a designated period. This should allow users to see overdue equipment as well as future work required.
  • Check if reports are available to provide scheduling information, items that are overdue, identify out of tolerance equipment, allow traceability of calibration standards, and provide lists of the various types of records stored in the database. Also, an audit trail report should be available.
Other
  • Confirm that attachments and/or supporting data is easy to access so that, in the event of an audit, you can easily produce the requested records for an inspector.
  • Make sure it fits within your budget!  Compliance doesn’t have to be expensive in this case.

Overall, look for compliance and ease of use because it is more likely the system will remain in compliance if it is easy to use. Complex systems are more difficult to maintain. So try out any system before purchasing to see if it works with your workflow in a free trial. Do your research up front and save time and money in getting a system that fits your budget and process.  Contact us and we will be happy to help and give you even more key features  to look for in a validated CMMS!