Dual-factor digital signatures and immutable audit trails record every calibration event, adjustment, and out-of-tolerance event.
Never miss a calibration run with automated notifications, email alerts, and a color-coded GxP calibration calendar.
Out-of-Tolerance events automatically trigger CAPA or Deviation records in the NextGen QMS to restrict non-compliant instrument usage.
Upload third-party calibration certs or generate digital certificates in-system, including metadata mapping and electronic sign-offs.
Explore the rich feature-set built to satisfy GxP validation requirements and maximize quality assurance.
Maintain a master record of all instruments requiring calibration, including balances, pipettes, autoclaves, incubators, pressure gauges, and environmental chambers. Log ID, range, and location.
Define custom calibration intervals (daily, monthly, quarterly, semi-annually, or usage-based). The system auto-calculates next due dates and sends early alerts to operators.
If an instrument fails its calibration verification, the software automatically marks it as 'Out-of-Service', prints warning labels, and locks it from cleanroom usage.
Input raw calibration readings directly. The system automatically cross-references results against programmed tolerance limits to determine Pass/Fail status.
Support for internal metrology workflows as well as outsourced vendor activities. Track vendor certificates, qualifications, and performance scorecards.
Scan barcodes or QR codes affixed to physical equipment to instantly pull up active calibration status, history, next due date, and validation logs.
Our software enforces a strict, step-by-step compliant process, guiding assets or audits from draft onboarding to final validation.
Register the instrument with unique tags, upload manufacturer specs, define tolerance boundaries, and set calibration frequency.
The calibration schedule triggers automated calendar alerts, notifying assignees and reservation engines of the upcoming calibration window.
Technicians perform calibration in accordance with active SOPs, entering test-point measurements and environment parameters directly in the software.
The platform calculates deviation from true values. If the reading exceeds tolerance, the instrument is flagged, locked, and a deviation is raised.
Enter internal reports or upload vendor-issued certificates. Attach metadata fields including standard instruments used (NIST traceable).
The calibration event goes to the QA supervisor. Approval requires validation of username, password, and manifestation of intent.
Upon approval, the asset status changes to 'Calibrated & In-Service' in the central registry and NextGen QMS. A digital log entry is saved.
This module operates independently but integrates natively with other QMS processes to ensure closed-loop compliance and automatic record updates.
Every calibration task is linked to its approved testing SOP, forcing technicians to review correct procedural methodologies before entering calibration data.
A technician cannot sign off on a calibration report unless their profile in Training LMS displays active qualification status for that instrument type.
An OOT calibration failure instantly triggers a Deviation record in the QMS, locking the instrument from usage until a CAPA investigation is completed.
Reduce human error, save quality assurance overheads, and streamline regulatory compliance.
Eradicate spreadsheets and paper trackers. Automated scheduling ensures you never miss a critical calibration due date.
Early notifications and instant OOT lockouts prevent the usage of drifted sensors, eliminating batch failures.
Instantly print full calibration history, certificates, standards traceability logs, and user credentials during regulatory inspections.
Ensures adherence to ALCOA+ standards. Raw readings are locked and time-stamped immediately at the point of data entry.
Fully optimized to support critical environments with strict GxP, ISO, or GLP compliance requirements.
We combine cutting-edge software design with rigorous pharmaceutical validation methodologies.
Learn MoreFully validated cloud infrastructure, or secure on-premise installation to suit global data hosting policies.
Engineered following GAMP 5 software lifecycle guidelines to guarantee smooth validation processes.
Every action, modification, and login event is captured in an immutable, time-stamped electronic ledger.
Scale from a single research lab to global manufacturing sites with multi-tenancy and active directory support.