Seygen, a global pharmaceutical research and manufacturing company, deployed Applicare across their GxP-regulated laboratory information systems, ERP, and manufacturing execution systems — achieving 21 CFR Part 11 compliance while reducing system downtime by 78%.
Pharmaceutical manufacturing operates under a set of constraints that most IT observability tools weren't designed for. Every system change must be documented in an audit trail. Every alert must have a defined response procedure. Every system accessing or modifying batch records must be validated under 21 CFR Part 11.
Seygen's IT team was managing LIMS (Laboratory Information Management Systems), MES (Manufacturing Execution Systems), and SAP ERP across 6 manufacturing sites. Their existing monitoring approach — separate tools for each system, manual incident documentation — was creating compliance gaps and hiding performance problems until they became production stoppages.
A single LIMS downtime event during a batch run at Seygen could require a full batch investigation, potentially destroying product worth $2-4M. The pressure to prevent downtime is not just operational — it has direct regulatory and financial consequences.
Applicare's deployment at Seygen followed a validated change control process. The entity graph was configured to model the relationships between LIMS, MES, SAP, and the underlying infrastructure — so the impact of any system event could be traced to its potential effect on batch data integrity.
All Applicare actions — automated remediations, configuration changes, alert responses — are logged to an immutable audit trail that satisfies 21 CFR Part 11 requirements for electronic records. The IntelliTune remediation engine operates within validated parameters, with every action producing a timestamped, signed record of what was done, when, and why.
Once the entity graph was in place, performance patterns became visible that had been invisible to individual-system monitoring. A slowdown in the LIMS sample results API wasn't isolated — it was correlated with a database query pattern that only manifested during end-of-shift batch close, when 200 analysts submitted results simultaneously.
ArcIn identified the N+1 query pattern in the LIMS application within the first week of deployment. The fix — connection pool tuning and query optimisation — was implemented under change control and reduced end-of-shift LIMS response times by 340ms, eliminating the daily period of analyst frustration that the team had assumed was simply "how the system works."
Before Applicare, Seygen's compliance posture was assessed quarterly — a snapshot in time that frequently missed drift that occurred between audits. Applicare's continuous compliance monitoring meant that configuration drift, access anomalies, and system behaviour deviations were flagged in real time rather than discovered months later.
Our last FDA audit reviewer specifically commented on the quality of our system monitoring documentation. For the first time, we had real-time evidence rather than reconstructed logs. Zero findings on any monitored system.