Easily manage equipment validation phases. Track protocols, sign-offs, and compliance statuses under GAMP 5 standards.
Replaces paper logbooks. Automatically records usage hours, calibration events, cleanings, and maintenance runs.
Track breakdowns, preventative actions, spare parts inventory, and warranty/AMC contracts in real time.
Authorize specific users or cleanroom departments to check out, validate, or perform procedures on assets.
Explore the rich feature-set built to satisfy GxP validation requirements and maximize quality assurance.
Track model, serial numbers, warranty terms, locations, and department allocations. File attachments store operator manuals and qualification records.
Manage key Qualification phases (Installation, Operational, Performance Qualification) directly in the system with signature tracking and date scheduling.
Log breakdowns immediately, schedule service engineers, track repair costs, and log exact down-time metrics to calculate MTBF.
Operators check-in and check-out of instruments with dual-signature entries. Capture product batch codes run on the machine.
Define Annual Maintenance Contract (AMC) dates and warranty terms. Automated notifications alert managers prior to contract expirations.
Affix QR tags to instruments. Scanning immediately routes to active logbook entries, maintenance status, and qualification certificates.
Our software enforces a strict, step-by-step compliant process, guiding assets or audits from draft onboarding to final validation.
Add new equipment to the master registry, assign unique identification tags, and define regulatory categories (GMP/GLP/GCP).
Verify physical components against specifications, record serial numbers, upload electrical certificates, and log approval signatures.
Verify that system alarms, switches, controls, and software operate correctly in the target environment. Upload protocol reports.
Verify that the equipment consistently performs within established tolerances under load conditions. Lock asset until PQ approval.
Operators check-in, record batch numbers, track run-time hours, and log cleaning events using 21 CFR Part 11 electronic signatures.
Preventive maintenance, calibration schedules, and service agreements auto-trigger checklists to maintain qualified status.
Formally retire assets, lock record modifications, and archive the full history, logs, and audit trails for permanent inspection readiness.
This module operates independently but integrates natively with other QMS processes to ensure closed-loop compliance and automatic record updates.
Share equipment profiles seamlessly. Calibration statuses, tolerances, and calibration OOT events feed back to update the asset's active/inactive status.
Automate maintenance ticket scheduling. PM tasks lock the asset's digital logbook automatically to prevent cleanroom run assignments during servicing.
Equipment breakdown events logged in the portal instantly raise Deviation cards in QMS to investigate batch run implications.
Reduce human error, save quality assurance overheads, and streamline regulatory compliance.
Transition from manual paper binders to a secure electronic registry with absolute compliance to USFDA data integrity norms.
Preventive maintenance calendars and early AMC alerts allow proactive service scheduling to maximize lab productivity.
Centralize all validation documents, protocols, IQ/OQ/PQ milestones, and verification reports in a single, accessible ledger.
Track the full historical log of who used the machine, for which product, when it was cleaned, and when it was calibrated.
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 MoreBuilt in accordance with GAMP 5 requirements, ensuring the software can be validated in complex regulated facilities.
Restrict asset adjustments, calibration overrides, and qualification approvals using dynamic role-based access rules.
Log all logins, views, downloads, and modifications in a cryptographically secured database trail.
Native APIs connect with enterprise ERP and maintenance systems, syncing inventory and operational data.