Manual Environmental Monitoring Is Costing You: Here’s How A CDMO Changed That
For contract development and manufacturing organizations (CDMOs), every production must meet tight timelines, multiple client specifications, and the pharmaceutical industry’s strictest quality standards.
Yet many CDMOs still rely on paper-based records and manual checks for Environmental Monitoring (EM) – systems that strain resources and leave room for errors. By contrast, digital and automated EM streamlines data capture, strengthens traceability, and delivers real-time insights that auditors and clients now expect.
Convincing internal stakeholders to make the shift to digital EM can prove tricky. Alicia Ruiz, Group Quality Manager at FAMAR, a CDMO Company, shares the core arguments she used to secure management buying and funding for a full transition to digital EM.
Feeding the business case with robust arguments
Alicia says it herself: the business case is a crucial step in such a transformation. It is the only way you can show stakeholders the importance and the value of going for digitalization – the end goal being, of course, continuous manufacturing.
Her advice is to show what the operations look like now, and what they would look like with the new process.
“We calculated the time we were investing in investigations and data monitoring and how a new process could reduce these times, gain efficiency, reduce contaminations. But not only this! Also have availability of data, reduce the cost of non-quality and have customer and agency satisfaction”
In her words, the mistake many companies make is not taking into account the lengthy hours it takes for each and every one EM investigation, and the many teams they impact.
“It’s calculated that [every investigation] takes a minimum of 12 hours. When you run an investigation, you are delaying the release of the product and keeping your product in a warehouse.”
Easy to see that all these expenses quickly added.
Convincing Stakeholders with expected benefits of a Digital EM process
With the transition to Digital EM, FAMAR expects to:
- Gain operational excellence
- Be aligned with Annex 1, reducing the risk of contamination from sampling processes
- Be aligned with sustainability strategic objectives
- Retain talents by providing them with more strategic tasks
- Further improve processes with the free time that talents will get
“[Digital EM] is a very potent tool, that no sterile manufacturing can avoid – and that for sure, non-sterile should also think about”
Digitalizing EM is no longer optional for growth minded CDMOs. Like Alicia at FAMAR, you can unlock the future or pharmaceutical quality with digital environmental monitoring.
