You can have a flawless Grade A cleanroom and the most advanced equipment—but if your operational data (temperature, humidity, differential pressure, batch mixing parameters, etc.) does not comply with ALCOA+ principles (Accurate, Original, Contemporaneous, etc.), your facility is still set up to fail during an inspection.
Data Integrity (DI) is not just a laboratory topic. In the Industry 4.0 era, DI lives in SCADA, BMS, and EMS. Any system that allows an operator to change the system time or delete fault history is essentially a compliance “death sentence.”
How does Humiley Group INC build and verify a “Data Shield”?
At Humiley, we work with one core mindset: “Data is legal evidence.” We don’t merely install software—we configure Compliance by Design. Our implementation and verification approach includes:
1. User Hierarchy & Security Check
One of the most basic—and most common—failures is shared user accounts. Humiley establishes a strict role-based access control (RBAC) matrix across control systems.
How we verify: We perform challenge testing—intentionally attempting to access Settings/Configuration using an Operator-level account, and deliberately entering incorrect passwords multiple times to confirm account lockout and security enforcement.
2. “Non-erasable” Audit Trail
The system must capture every action: Who did what? When? Why was it changed?
How we verify: Humiley engineers execute controlled setpoint/parameter changes, then extract Audit Trail reports to confirm the system reliably records the event. We also ensure audit trail/log files are protected (encrypted/secured) and cannot be altered externally.
3. Data Redundancy Architecture
Data loss is a major DI failure.
Solution: Humiley designs Server/PLC infrastructure with RAID and dedicated UPS protection. We validate robustness through hard evidence—simulated abrupt power loss and hot-swap drive tests—to demonstrate data remains complete, intact, and gap-free (no “gaps in data”).
At Humiley Group INC, we deliver a system with absolute “truthfulness”—so you can face even the toughest inspectors with confidence.
