eCalPM – Calibrations

eCalPM – Calibrations is a module from Pharmasoft designed to manage the complete lifecycle of instruments and measuring devices used in pharmaceutical and biotech manufacturing and laboratory environments. It covers the full process from scheduling and execution through to evaluation and certification, maintaining a centralized instrument master database with full traceability of calibration history, deviations, and corrective actions.

The module is intended for regulated industries requiring compliance with GxP and ISO standards, including 21 CFR Part 11. It supports a range of measuring and test equipment (M&TE) such as balances, pH meters, thermometers, pressure gauges, flow meters, spectrophotometers, dissolved oxygen meters, and process control instruments.

Automated Calibration Scheduling and Tracking

• Centralized calendar for all calibration activities across assets
• Auto-generated notifications for due, overdue, and upcoming calibrations
• Equipment categorization based on criticality and usage
• Real-time tracking of calibration status across all instruments
• Overdue instruments are flagged with visual indicators to prevent use in critical activities

Electronic Calibration Records and Certificates

• Digital calibration worksheets with step-by-step data capture
• Secure electronic signatures compliant with 21 CFR Part 11
• Automatic generation of calibration certificates and labels upon completion and approval, including instrument details, results, calibration date, and next due date
• Auto-attachment of calibration certificates and reports to records
• Complete audit trail maintained for every record modification

Tolerance Verification and Out-of-Tolerance Management

• Calibration data entered against defined acceptance tolerances
• Automatic evaluation of results against tolerances with pass/fail status flagging, eliminating manual calculation errors
• Integrated CAPA linkage for out-of-tolerance results
• Integration with other modules prevents selection of out-of-calibration instruments for critical activities

Performance Analysis and Compliance Controls

• Trend analysis to identify recurring equipment deviations and performance drift
• Risk-based calibration frequency optimization
• Inspection-ready logs aligned with GxP and ISO standards
• Supports audit readiness with complete traceability and defensible calibration evidence

Reported Operational Outcomes

• 99%+ on-time calibration compliance
• 15–25% reduction in measurement-related out-of-specification (OOS) investigations
• 65% reduction in calibration administration effort
• 100–300 hours of annual time saved per facility

eCalPM – Calibrations is part of Pharmasoft's broader suite of operations modules, which also includes preventive maintenance, breakdown maintenance, electronic batch manufacturing records, and equipment logbook management. The platform is positioned for GMP-compliant, Pharma 4.0 regulated manufacturing environments, with email notifications available for calibration due date alerts.