How RFID Based Asset Tracking aids in GLP/GMP Regulated Lab Management

Being responsible for the equipment in a GLP/GMP regulated lab is no easy task. Several compliance requirements have to be adhered to. AssetPulse’s RFID based asset tracking solutions have greatly helped streamline the equipment management of such locations.

AssetPulse RFID based Asset Tracking Software

Our real-time RFID based asset tracking solutions provide an accurate inventory of all equipment across geographic locations. It can detect addition or removal of components in qualified and/or validated systems like HPLCs. The Lab Manager can be alerted of such movements, thereby triggering a re-qualification process automatically. Failure to re-qualify can have serious logistical, technical and financial repercussions.

Several groups or departments within the organization are interested in knowing the whereabouts of the equipment. They include not only the actual users of the equipment – R&D personnel or cleanroom manufacturing personnel, but also other departments like Metrology or personnel who are responsible for calibration or preventive maintenance of the equipment. Each of these groups is looking for equipment at different times of the equipment’s’ lifecycle. Tracking compliance documents related to the equipment is also a time-consuming task. Often, the documents are stored in a separate physical location and are subject to the normal woes of searching for misplaced documents.

Before the use of RFID, the equipment databases were woefully out of sync with reality. This resulted in Finance and QA departments to initiate audits often, in order to update their databases. Small teams of scientists/researchers would need to be assembled, to scour the labs looking for equipment, severely impacting their overall productivity.

AssetPulse RFID based Asset Tracking Software Maintains Centralized Database of Asset Information

Maintaining accurate inventory of all the equipment and keeping their details up to date can be a full time job. Details include location, manufacturer, model, serial number, received date, deployment date and all maintenance related information including calibration/maintenance schedules, non-routine repairs, performance verification and revalidation dates.  The AssetPulse database allows all such detailed information to be maintained in one central database, accessible to all concerned players including R&D, Quality and Finance personnel.

Equipment qualification results in several sets of documents to be generated that are roughly slotted into three categories:

• Specification – Documents specifying the equipment from the user and manufacturer’s perspective, including the URS (User Requirements Specification), FRS (Functional Requirements Specification) and DS (Design Specification)
• Protocol – These encompass the procedures stating how qualification is conducted including test procedures, operating ranges and acceptance criteria
• Report – Include the Traceability Matrix and Summary Reports
• In the Specification group, the written document includes the critical attributes for the equipment from the user’s and manufacturer’s aspects. User Requirement Specification (URS), Functional Requirement Specification (FRS), and Design Specification (DS) are in this group.
• In the Protocol group, the written procedures state how the qualification will be conducted. This may include the test units, test procedures, critical test parameters, operating ranges, sampling plan, and acceptance criteria. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• In the Report group, the written document reports the qualification activities and results, and traces back to the test items with their specifications/ requirements Traceability Matrix, ™ and Summary Report.

Once Validation is complete, the equipment has to be regularly maintained including undergoing calibration and other preventive maintenance procedures. The AssetGather RFID system also helps personnel to locate the equipment when it is due for calibration.

The AssetGather database allows all relevant documents to be stored together with the equipment details. IQ (Installation Qualification)/OQ (Operational Qualification)/PQ (Performance Qualification) documents, standard operating procedures, warranty certificates, calibration certificates can be made easily accessible through the database. This allows audits to be done a lot quicker, instead of having to sift through a myriad of documents in order to locate the appropriate pieces of paper.

Thus, the use of RFID can effectively bridge any visibility gaps with respect to Asset Management in Analytical labs, hospitals and in pharmaceutical manufacturing supply chains.