Air quality, surface sterilisation, contamination levels and a host of other considerations must all be closely monitored and adjusted to ensure they remain uncompromised for the best operation in a cleanroom. In the eyes of regulators, it is not acceptable to merely keep a tight grip on these aspects. Every action, reaction and consequence must also be observed and recorded to ensure compliance and secure the organisation’s continuing viability.
The pharmaceutical sector requires this level of scrutiny and documentation more than most; a momentary compromise in the integrity of a lab or cleanroom can cost lives. Whatever the potential consequences, regulatory compliance is just as essential.
Many organisations using cleanrooms are unaware of the recent technological developments that can deliver tangible improvements for their people and processes very quickly, simply and cost effectively. These systems are already helping countless companies to reduce risk and future-proof success by offering very scalable and robust ways to better manage what has become, perhaps, the greatest commercial commodity: data.
Some pharmaceutical companies have migrated from paper-based records and storage to electronic quality management systems (EQMS). The shift is likely to be followed by others as the benefits to demonstrate compliance and improve efficiencies become unquestionable.
This evolution of technology is improving the effectiveness of document and training record management, as well as reducing wastage of both physical and human resources. This, I believe, will become standard practice across all industries in the very near future, driven as much by cost saving as ease-of-use.
The natural benefit of a digital system, rather than a traditional paper-based one, is that trends can be identified quickly, powerful tailored metrics easily produced, reporting delivered to the appropriate destination automatically and in real-time. All of these things combined make maintaining and demonstrating compliance and – more importantly – correcting ineffective or inappropriate practices, much simpler. It would lead to more productive teams and reduce the chance of regulatory fines or sanctions.
Mark Stevens, managing director, Formpipe Life Science
EQMS are also proving effective at providing further benefits through their training modules. In the case of most cleanrooms, there are a high level of manual operations carried out on aseptic, sterile and classified environments. A really important aspect of compliance is being able to demonstrate that the operators involved are fully trained and competent against the current approved procedures. A good EQMS will monitor the level and currency of each team member’s training status, provide training resources to a set schedule, and then assess whether materials have been not only read, but also understood.
The automation of quality assurance to ensure compliance can alleviate pressure from training and quality teams and save substantial time and money in the process. The status of equipment needs to be monitored and documented, too. Calibration, for example; although the old ‘tested’ sticker with a date on it can be effective, it fails to be so if someone doesn’t remember to frequently check the sticker. Using spreadsheets for an overview of asset condition, service and repair schedules is rife with risk; the integrity of the data is often questionable and there is no option for Excel to flag potential compliance risks.
This method requires manual, and often excessive, administration. More reliable is the holistic visibility over each piece of equipment’s life cycle that comes with using technology-based alternatives, such as asset management modules in EQMS. With this approach, the vital statistics of every piece of equipment can be pro-actively monitored and designated personnel alerted via push notifications when an action needs to be taken.
The greatest benefit of this technology is its ability to unify a diverse range of documentation, processes and teams.
