Managing 21 CFR Part 11 with Mainsaver CMMS

Tech Group is a leading global contract manufacturer of medical devices. The manufacturing plant in Ireland specialises in metered-dose inhalers for the treatment of conditions such as asthma.

Customer

The Tech Group

Sector

Life Sciences

Situation

Requirement to procure a CMMS system with a view to improving departmental record-keeping and thereby visibility of performance.

Implementation

Tech Group had previously managed its maintenance regime using printed-off paper work orders, the details of which were later added to spreadsheets by administrative staff. Although carefully managed, the process had important limitations. Because every part of the maintenance workflow – requesting, scheduling, acceptance, completion – was being created manually, it was difficult to obtain an accurate snapshot of performance at any given time and thereby exercise full control over it.

When the time came to evaluate competing CMMS solutions, the field was narrowed down very quickly because key functions were absent in many of the offerings. Mainsaver won out because it was considered by far the easiest to use and – uniquely - had a dedicated 21 CFR Part 11 module as part of the package.

The 21 CFR Part 11 regulations are issued by the US Food & Drug Administration and relate to storage, transmission and validation of electronic records. Any company supplying manufactured goods in those categories to the US is subject to compliance with those requirements.

Implementation of Mainsaver commenced with systematic collection of site plant data to create a brand new, properly-structured asset register. The engineers were then trained on how to use Mainsaver and immediately afterwards, the new asset database was set up in an as-live test environment that Spidex refers to as the “Conference-Room Pilot”. In this day-long practice run-through, Tech Group staff were able to apply their new skills and system knowledge which helped to ensure a smooth transition on go-live day.

Result

Better co-ordination of maintenance works was noted and easier, more accurate recording of asset information which created measurable traceability improvements. Mainsaver also facilitated better root-cause analysis to identify opportunities for preventative maintenance to reduce instances of machine repair.

“Mainsaver was certainly the most easily navigable of the CMMS systems we evaluated, which made it the perfect choice in terms of day-to-day usage by our engineers. The dedicated 21 CFR Part 11 module was a critical factor.””

Keith Henderson

Facilities & Maintenance Manager

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