What digital EM transformation really looks like: insights from three teams who have lived it

Digitalising Environmental Monitoring is often described as a technological shift. But for the teams who experience it directly, the real impact goes far beyond moving from paper to digital. It reshapes how time is used, how data is trusted and how decisions are made inside contamination control programs.

In SherpaPharma’s latest roundtable session, three organisations took part: a clinical-stage biotech, a commercial biologics manufacturer and a contract testing laboratory. Each of them shared what digital transformation actually looked like inside their QC operations.

This article summarises the main insights discussed during the session.

The discussion brought together three professionals who have led or supported digital EM transformation inside their organisations.

• Donald François, Senior Manager of QC Microbiology at Rocket Pharma, who spoke from the perspective of a commercial-scale manufacturer working with advanced therapies.
• Aung Lwin, Senior Director of Quality Control at Artiva Biotherapeutics, a clinical-stage biotech developing NK cell–based therapies.
• Paul Lutz, Director of Environmental Monitoring at Focus Labs, a contract testing laboratory that supports multiple clients, products and sampling plans across different sectors.

Together, they offered a practical and experience-driven view of what happens when EM programs move from paper and spreadsheets to a validated digital system.

Despite operating in different contexts, all three teams described remarkably similar starting points:

• Excel-based trending that required manual databases for every program or client.
• High variability in data entry and interpretation.
• Significant time spent on documentation instead of microbiology.
• Uncontrolled tools such as spreadsheets or custom files that created data integrity risks.
• Increasing operational complexity even in tasks that were supposed to be routine.
  

Donald François from Rocket Pharma described it clearly:
“A simple EM task becomes complicated once you stack the paper, the binders, the databases and the logs. Suddenly you are not monitoring a room, you are managing a system of systems.”

For contract labs, the effort was multiplied by the number of clients. For start-ups, the concern was scalability and avoiding the creation of legacy processes that would not last. Across all groups, Excel files remained the default tool, even though it was no longer sustainable.

Even with different operational realities, the motives for moving to a digital EM platform converged around five needs:

• Compliance and data integrity: Part 11 requirements, ALCOA+ expectations and the risk of data drift were major drivers. Start-ups emphasised the need to build validated systems from the beginning.
• Efficiency: Teams needed to reduce the time spent on transcription, verification and multi-step documentation.
• Scalability: EM programs grow fast. Manual systems could not keep up with increasing sample volumes.
• Flexibility: Contract labs required a system capable of supporting diverse client requirements. Manufacturers needed software that adapted to their workflows instead of the opposite.
• Real-time access to data: Decisions were often slowed down by fragmented or delayed information. Teams needed visibility rather than reconstruction.

The panelists agreed that the decision was not based on a single feature. It was the overall structure of the system and how it fits real workflows.

A true web-based platform
No local servers or heavy IT infrastructure were required. This was especially relevant for fast-moving organisations.

Aung Lwin from Artiva Biotherapeutics highlighted that choosing a validated, web-based system was critical for a fast-moving clinical-stage environment, where implementation speed and compliance must go hand in hand.

Ease of use
Sherpa can be learnt and retained without relying on super-users or lengthy SOPs. As one of our clients said, “It’s like riding a bike.”

Configurable workflows
The system adapts to the needs of each program. Teams do not need to redesign their processes to match the software.

The handheld Sampling Device
Paul from Focus Labs highlighted how the BCR changed their sampling workflow. Instead of handwriting on plates or adding manual labels, his team now scans samplers, plates and incubators directly into the system. This reduced errors, eliminated repeated touches and made field sampling and incubation much faster.

Predictable implementation and validation timelines
For some organisations, timing was critical. Several highlighted that SherpaPharma respected the proposed schedule from start to finish.

Collaborative support
Implementation was described as guided, responsive and solution oriented.

Each organisation followed a different path, but several common themes emerged.

Rocket Pharma

They operate in a fast-paced environment where internal projects move quickly. SherpaPharma consistently stayed ahead of their internal timeline and support was immediate and proactive.

Artiva Biotherapeutics

The project followed the planned timeline exactly. The main internal bottleneck was SOP writing, not the configuration of the platform itself.

Focus Labs

Their implementation required alignment with numerous clients. This extended the timeline, but the delay came from internal coordination rather than software readiness.

Once the system was fully adopted, the teams reported measurable and operational improvements.

1. Fewer GDP (Good documentation practices) errors: Automated capture of metadata and controlled workflows significantly reduced transcription and documentation issues.
2. Less manual work: Documentation for a single sample previously required multiple signatures and checks. With digital workflows, most of that effort disappeared.
3. Faster and more accurate trending: Filtering, reviewing and analysing EM data became significantly faster and more consistent.
4. More time for real microbiology: Teams were able to focus on investigations, interpretation and improvement instead of administrative tasks. As one participant noted, “We are increasing first-time quality. Our talent can focus on innovation instead of paperwork.”
5. Capacity to innovate: Some facilities began exploring integrations with automated incubation technologies, an option that was not possible with paper or spreadsheets.

Digital EM is no longer an aspiration reserved for large companies. It is increasingly seen as a practical and necessary evolution for organisations of all sizes, from clinical-stage biotechs to commercial manufacturers and contract laboratories.

The roundtable highlighted a clear message:

Digital transformation is not only about technology. It is about freeing people, strengthening decisions and elevating the quality of contamination control programs.

SherpaPharma provides the structure that enables this shift by fitting the way teams actually work.

Want to hear the full conversation?
The complete roundtable discussion is available on demand in the following link