When people outside of the life sciences sector ask me what I do, I often start with quality compliance, a field that ensures structured, established processes provide patients with safe, effective and quality therapies when needed. An integral part of that process in the life sciences industry is GxP. GxP is an acronym for “Good Practices” — regulations that govern how ISS works with clients in that sector. The “x” can stand for manufacturing (GMP), laboratory (GLP), distribution (GDP), documentation and data (GDDP) and more.
At its core, GxP guarantees we do things the correct way, with consistency and control. It’s how we protect not only our clients’ operations, but, most importantly, the patients whose lives depend on the therapies and products in development.
ISO vs. GxP: Minimums vs. Specifics
People sometimes confuse ISO standards with GxP regulations. ISO provides the minimum requirements for a quality management system, written broadly so they can apply to a wide range of industries and sizes — from service to pharmaceuticals, mom-and-pop shops to large corporations.
But GxP goes much further. Where ISO might say, “There should be a process for managing documented information and retaining documented information (records),” GxP specifies exactly what that looks like. For example, documents must be revision controlled, have effective dates and issuing departments; records have formatting requirements; and a specific type of ink (indelible) must be used when recording information. It’s about leaving no room for ambiguity, because ambiguity in this field can have real-world consequences.
Why Every Detail Matters
Something as simple as filling out a form has strict requirements under GxP. Fields cannot be left blank; if they are not applicable, they must be marked “N/A,” initialed and dated. Date formats must be consistent throughout. Records must be permanent, written in ink — no pencils, no gel pens, no markers.
These are not trivial details. They ensure that the work we do is traceable, verifiable and trustworthy, safeguarding against errors that could impact production or delay treatments from reaching patients. In facilities management, cleaning in life sciences is not like cleaning in a typical office. We follow client-specific SOPs because every site and every product is unique. Our people must understand that their work matters, as it protects patients waiting for therapies that could sustain or even save their lives. That is why we run annual Quality campaigns; each focused on a key area like Good Documentation and Data Practices or Quality on the Floor. When we focus on an area, performance improves — sometimes dramatically.
Oversight and Engagement
Compliance isn’t about teaching people how to do something but rather helping them understand why. We coach our Placemakers during daily area walkthroughs, pointing out when a process isn’t followed correctly, correcting in real-time and explaining the rationale behind why following procedures is important. And we celebrate when things are done right.
To ensure alignment with clients, we use a combination of quality agreements, KPIs and dashboards. Quality agreements spell out expectations for deviation investigations, timelines, roles and responsibilities of both parties, the client and ISS, while dashboards give us and our clients clear visibility into performance, which keeps us accountable and transparent.
Our Quality team has moved from simply providing oversight of our processes to a much more engaged Quality organization. Through Quality on the Floor, we walk the processes on the floor, talking directly with our teams, coaching and building ownership. That evolution reflects the industry as a whole: clients expect compliance as well as active partnership and continuous improvement.
Why Self-Delivery Sets Us Apart
One differentiator I’m proud of is ISS’ self-delivery model. Our quality management system is robust and mature — having been tested since 2017— complete with global standards, global SOPs and templates established on industry regulations. We own the process, and that ownership makes a tangible difference.
Ultimately, our work revolves around compliance, trust and relationships. Trust with our clients, trust with our Placemakers, and trust with our suppliers. If people know you care, they’ll care about what they do. That trust builds accountability, ownership and a culture where excellence is the expectation — the pursuit of excellence every day.
Find this blog informative? Read the first installment of our series on facility management and life sciences, Building a Culture of Accountability, by David Miller, which addresses how leadership, trust and cultural alignment are required for true account accountability and ownership.
