Pharma Grade.
FDA Ready.

Pharmaceutical equipment must maintain complete documentation of all maintenance, calibration, and modifications. Manual record-keeping creates gaps that trigger FDA 483 observations and warning letters.

Reliatic provides 21 CFR Part 11 aligned electronic records with full audit trails. Every change is timestamped, user-attributed, and tamper-evident. Electronic signature workflows and reason-for-change documentation are built-in.

API manufacturing facility passed a comprehensive FDA inspection with improved equipment traceability and audit readiness.

IQ/OQ/PQ documentation is often scattered across paper files, shared drives, and individual computers. Re-qualification schedules are tracked manually, leading to lapses that compromise validation status.

Centralized qualification management with rules-based re-qualification alerts. Links calibration records, change controls, and preventive maintenance to qualification status. Regularly refreshed validation dashboards show equipment fitness.

Biologics manufacturer reduced qualification documentation time. Alerts helped reduce qualification lapses that would have required expensive re-validation.

Clean steam, purified water, and HVAC systems are critical utilities that directly impact product quality. Traditional reactive maintenance risks contamination events and batch losses.

Condition-based maintenance for critical utilities with scheduled monitoring integration. Track water quality trends, filter differential pressures, and heat exchanger performance. Risk-based inspection prioritizes critical equipment.

Injectable manufacturing site eliminated 4 utility-related deviations per year. Water system sanitization intervals optimized based on bioburden trending, saving $180k annually.

Autoclaves, isolators, and clean-in-place (CIP) systems require meticulous maintenance records. Any equipment failure in sterile processing can compromise entire production batches worth millions.

Specialized maintenance protocols for sterile processing equipment. Tracks steam penetration tests, biological indicators, and seal integrity. Integrates with batch records to establish equipment-product correlation.

Sterile manufacturing facility achieved 99.8% critical equipment availability. Proactive seal replacement prevented 2 autoclave failures that would have scrapped $4.2M in product.