Peter Brogan
Operations Director, ABM Ireland
Dinny Crowe
Vice President, Operations, ABM Ireland
Eanna Kavanagh
Senior Director – Transformation, ABM Ireland
In the strictly regulated life science sector, digital technology allows facility management services to be carried out in a way that drives compliance and improves efficiency.
What are the key operational and compliance pressures facing regulated life sciences facilities today?
Dinny Crowe (DC): To guarantee their products are safe, effective and produced to the highest quality, life sciences companies must adhere to strict regulations from the FDA (US Food and Drug Administration), the European Union and other global regulatory agencies. That means their own staff in production and operations must follow strict compliance rules. External contractors from companies like ABM, who are delivering facility management services on site, such as cleaning laboratories, must also be compliant to ensure we don’t affect any part of the production process.
What challenge does this represent for you?
DC: For example, when our staff clean a laboratory in a highly regulated GMP (good manufacturing process) environment, everything must be tracked from start to finish. That includes the gowns worn by cleaners, chemicals in their cleaning products, tasks they complete, processes they use and the time the cleaning was carried out. When these processes and procedures are recorded manually in paper-based logbooks, what can happen? Peter Brogan (PB): Cleaners can clean a lab in a way that’s fully compliant with regulations. But if they don’t sign the logbook afterwards, because of time pressure or human error, as far as compliance rules are concerned, the cleaning didn’t happen at all. Or say there was a product failure, and an auditor requests cleaning records from a particular lab. Then it’s all hands to the pump while everyone hunts for the paperwork.
How do technology-enabled service partners support measurable performance improvement?
PB: Digital solutions are compliant with regulations and perform the same function as paper-based systems, but far more effectively. For example, we have a software platform called Connect, which allows teams to electronically document and sign off on their work. They can’t skip a step, either, because once they scan into a controlled area using a QR code, the system won’t let them go further until they confirm they’ve completed the job. Connect drives compliance by ensuring critical processes are executed correctly, reduces risks of errors and deviations, provides a regulatory and audit trail to show in real-time that compliance has been met and eliminates the need for paper logbooks. Plus, it reduces downtime, so it’s better for productivity, and it means a company is always audit-ready.
Any data is easily accessible to the company through a central data stack, enabling stakeholders to make data- driven, actionable decisions. How the data is shown can also be configured, so the client can easily access the most important data points they need for their business. Eanna Kavanagh (EK): The system is also compliant with the FDA’s 21 CFR Part 11 regulations for secure and reliable electronic record-keeping. That’s an industry first and proving to be a differentiator in the marketplace. And it’s not only for use by cleaning staff. It’s scalable for any activity or service within that type of controlled environment, such as technicians managing and maintaining HVAC (Heating, Ventilation, and Air Conditioning) systems.
Plus, it reduces downtime, so it’s better for productivity, and it means a company is always audit-ready
How should site leadership approach digitisation in a GMP environment?
DC: In a controlled way. In any industry, organisations don’t suddenly stop using manual processes and switch to a digital solution. They’ll have a roll-out in a particular area, department or building with a proper lead-in time and training. They’ll run their traditional manual paper- based method alongside a digital system for months until they get to a place where everyone is fully trained and comfortable with the new way of working. When it’s apparent that there have been no deviations in the new system, a decision can be made to retire their traditional paper-based processes and move full-time to digital.
