Location Identification – are you 100% sure that the particle counter is in the right
location? Is the location ID built into the remote sensor? Are we sure that after the unit comes back from service that it has been put back in the right location? Human error plays a major role and it has been shown that mistakes can occur and remote particle counters coming back from service are mistakenly placed at the wrong location.
What does this mean? Well, as the data coming from the sensor is picked up from the EMS from the wrong location, a small mistake can have a huge impact and lead to major data integrity issues. Look for remote particle counters with technology where the location ID is embedded in the location mounting bracket rather than the particle counter. This way, any remote particle counter can be inserted and the data will be confirmed from the right location 100% of the time.
Data Storage Redundancy – Having data records backed up on the remote particle
counter assures redundancy in case a software issue occurs in the transmission of real time data. Choosing a particle counter with sufficient buffering in data collection will enable critical data to be downloaded at a later stage back into the monitoring system software. Redundancy is a major advantage as the data becomes more critical.
Audit Trail – In order to follow the ALCOA standard, an audit trail built into the equipment or software is an absolute must. (21CFR11 in monitoring systems are required). Seek particle counter technology with built in audit trails to satisfy ALCOA requirements for who, when, what and where events.
User Security Levels – The system must conform to 21CFR11 guidelines. Up to three
security levels from operator to manager and administrator must be available with the usual compliant parameters such as password length, password aging and password control. User security levels are a 21cfr11 requirement and particle counters should have the ability to manage and control user access.
System Validation – A complete validation of the data records must be conducted by
verifying the accuracy of the data to the location of where the data is generated. This is a must do exercise and should be rolled into the Installation and Operational Qualifications IQ/OQ protocols. Seek vendor IQ/OQ protocols and always conduct a Performance Qualification (PQ) to verify operational accuracy before going into production.