The vast majority of pharmaceutical manufacturers are currently in the process of digitalizing their QC labs’ data management. A poll conducted during a recent webinar revealed that 75% of the 127 respondents were beginning the transition from written to digital. Because upgrading a facility in one big digitalization effort is usually too disruptive, most are taking a controlled step-by-step approach, implementing individual digital QC solutions one by one. These must be integrated into the existing IT framework in a way that ensures data integrity (see earlier article on ALCOA+ principles), a regulatory requirement which—where data are still handled manually— has become increasingly difficult to meet as requirements have risen. However, each manufacturing facility is different and has its own set of internal regulations and policies. Any new testing system should therefore offer the flexibility to operate in a broad range of settings, allowing it to provide the benefits of digitalization while ensuring compliance at every stage of the facility’s incremental transformation process.
Digitalization to improve data quality
For most QC managers, the main priority when going digital is to improve the quality of their data. Data integrity minimizes the risk of erroneous data handling and improves decision-making, while traceability of consumables facilitates audits. To comply with these requirements, all relevant data and metadata of a QC test must be captured, linked to the correct batch datasets, stored safely, and remain retrievable for change control and audits over the entire cGMP data life cycle. What to capture should routinely include instrument parameters, consumables data, user ID, time, location, comments on test execution and, of course, the results of each test. Scannable barcodes on consumables or on the display of the instrument make this much easier and more secure to do, avoiding misunderstandings and making double checks or further verifications unnecessary.
Ideally, test data would be fed into a LIMS and be analyzed using a management software. But under a step-by-step digitalization approach, these may not yet be implemented. This is why we have equipped our MAS-100 Atmos® compressed gas microbial sampler with the choice of several compliance levels at which to operate. Straight out of the box, it is freely configurable via touchscreen. Alternatively, it offers 21 CFR Part 11 compliant user management including defined individual access levels with unique login via hardware key, in combination with a password and/or PIN code, and the possibility to download audit trails. All necessary sample data can be simply scanned using a barcode reader and extracted by external software systems for easy traceability. These choices give users the flexibility to move from one level to the next as the facility’s digitalization evolves.
The need to support mobility
While all data for an audit should be retrievable from a single place, they are often recorded at various locations within a facility. However, Wi-Fi may not be available everywhere, safety considerations may restrict movement or sampling points may be difficult to access. Mobility-friendly QC testing solutions cope with such challenges. For example, when the Val@M qualification platform is used where there is no Wi-Fi, data can be entered offline, with the user still logged in and time stamps enabled. Once reconnected to Wi-Fi, the data is transferred.
Many testing workflows make it necessary to perform activities at several locations. A compendial sterility test, for example, involves the documentation of consumables’ data in a storage room, test execution in an isolator room, and reading of results at the incubator in the lab. To support digital and regulatory compliant recording of data at multiple locations in real-time, mobile electronic devices have proved their worth as components of QC testing solutions. To avoid error-prone data transcriptions, our M-Trace® digital companion solution for sterility testing is equipped with a wirelessly connected handheld mobile device that allows testing data to be scanned or entered manually at the various locations.
Flexibility to support the transition
In addition, the M-Trace® system offers optional headphones that keep the operator’s hands free to operate the pump. In this mode, it communicates commands to the operator who, in turn, gives confirmation by voice when a step has been concluded. All data are recorded contemporaneously by a software platform that was developed to be compatible with Windows, which gives the facility the flexibility to incorporate security measures already developed.
Nevertheless, for the foreseeable future labs will continue to receive QC data from multiple sources and in a variety of formats, for example supplier certificates as PDF files, screenshot images, and scans of printed tickets or handwritten notes. To facilitate regulatory compliance, we gave our Val@MTM instrument qualification software the capability to handle numerous data formats and thus support manufacturing facilities to manage their gradual transition toward QC data digitalization smoothly.
Author Details
Michel van Musschenbroek, BioMonitoring Commercial Applications Field Support, MilliporeSigma, Burlington, MA, USA
An affiliate of Merck KGaA, Darmstadt, Germany
Nicolas Lelievre, PhD, BioMonitoring Regional Application & Commercial, Tactics Manager, Millipore SAS, Molsheim, France
An affiliate of Merck KGaA, Darmstadt, Germany
Publication Details
This article appeared in American Pharmaceutical Review:Vol. 28, No. 2March 2025Pages: 34-35
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