Posts by Thibault

Faced with the need to modernise its environmental monitoring approach across two manufacturing sites, Douglas Pharmaceuticals turned to Dickson to deploy a compliant, centralised, and scalable digital platform. Douglas Pharmaceuticals, a major player in New Zealand healthcare Founded in 1967, Douglas Pharmaceuticals is a New Zealand, family-owned company that researches, develops, manufactures, and distributes pharmaceutical…

Your CO2 incubator display says everything is fine. Temperature steady. Humidity on target. CO2 holding at 5%. But that display only tells you what the incubator thinks is happening inside the chamber.   The sensor responsible for those readings has been sitting in a hot, humid environment, quietly drifting off baseline. If it drifts, the machine doesn’t know. It just keeps adjusting to a flawed…

Temperature and humidity mapping is one of the most consequential studies your team will conduct. Yet even experienced teams routinely stumble on the same seven mistakes. From skipping a written test plan to treating mapping as a one-time exercise, any one of them can compromise your dataset and put your compliance program at risk.  Mistake #1: Starting Without…

The greatest threat to your vaccine inventory might actually be the alarms designed to protect it.   When clinical teams are overwhelmed by frequent, non-critical alerts, “alarm fatigue” sets in, causing staff to tune out the very warnings meant to prevent a total loss.  The stakes of missing a true temperature excursion are massive. Beyond the devastating human cost of…

For years, one of the most persistent gray areas in pharmaceutical validation was a simple question: How long does a temperature mapping study actually need to last?   However, with USP <1079.4> now firmly in its enforcement phase, that ambiguity is gone. The industry now has strict, volume-based expectations for mapping duration and stress testing. This means facilities still relying on…

Most pharmacy and healthcare clinic vaccine storage programs are doing the right things. The challenge is proving it as efficiently as possible.   An inspector arriving at your facility checks both the temperature logs and the integrity of the entire cold chain audit trail producing them.   EU Good Distribution Practice (GDP) Guidelines and World Health Organization Annex 9…

Facility managers often feel a sense of accomplishment after their initial mapping is complete. However, that data is only a snapshot. Environmental dynamics shift significantly during extreme cold events, so your summer data may no longer reflect your facility’s year-round thermal profile.  Your HVAC system works differently when it’s cold outside than in the hotter months of the year. The colder air outside forces your system to pump heat, significantly…

Data availability and quality problems affect 80% of pharmaceutical organizations. These data integrity gaps create compliance vulnerabilities—especially during the fragile transitions between laboratory research, manufacturing, and distribution.    To achieve true compliance, organizations must treat GxP not as separate regulations for Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP), but as a continuum.   Recent…

For blood banks and pathology labs, the mission is clear: to protect the lifesaving supplies that patients depend on. Your team is dedicated to this goal, but the operational demands of ensuring constant audit readiness and preventing alarm fatigue can feel overwhelming, especially when two units of blood can cost as much as €875 and demand outpaces…

For pharmaceutical manufacturers, you know environmental monitoring systems are a key part of any quality management system, essential for pharmaceutical storage control, and serve as your first line of defense in an audit.   While many systems can log data, only a select few are truly built to help you navigate the complex challenges of a…