Cryotos eliminates paper PM planners, undocumented breakdowns, and missed calibration schedules — replacing them with a fully digital, 21 CFR Part 11-compatible maintenance platform built from real conversations with pharma maintenance leaders.
Five Maintenance Risks That Fail Pharma Audits
Risk 01
"We have a PM planner. We have to review it day by day so we are not missing something. If we have missed something, we have to file a deviation for that."
Risk 02
"Whether gaskets have been replaced or not — old one and new one with documented photographs needs to be attached to it. Otherwise only documented by the operator and not actually done."
Risk 03
"My main concern is software validation — in pharma we have to perform Computer System Validation. Because there are audits from USFDA and whatever data we are generating in our plant has to be accepted by the regulatories."
Risk 04
"Do you manage calibration schedules and a calendar for calibrations?" — (1,000+ assets, 30 labs, 70 engineers)
Risk 05
"6,000 live line items in engineering stores. Some items need min/max levels maintained — can the system auto-generate PRs to SAP when stock falls below minimum?"
Cryotos Solves All Five - In One Platform
In pharmaceutical maintenance, photographic evidence must be taken at the time of the activity to constitute valid GMP documentation. If a system lets technicians upload stored photos, a photo from yesterday can be submitted as proof of today's gasket replacement — a 21 CFR Part 11 data integrity failure that FDA auditors are specifically trained to find.
Cryotos enforces LIVE camera capture only. Technicians take photos directly through the Cryotos app at the moment of work. The system embeds a timestamp and GPS location in the image metadata. Gallery uploads are blocked. Every photo in a Cryotos maintenance record was taken at the right place, at the right time, by the right person.
Every maintenance record in Cryotos has an immutable, timestamped audit trail with individual user attribution — not shared logins. Role-based access prevents unauthorized modifications. Electronic signatures are enforced before work orders can be closed.
For the Computer System Validation (CSV) requirement that every new pharma software must pass, Cryotos participates directly in your validation exercise — providing IQ/OQ/PQ protocol documentation, supporting test execution, and generating the test evidence required for your regulatory submission. We shorten your CSV timeline, not extend it.
Cryotos manages the full calibration lifecycle for every pharmaceutical instrument. Each piece of equipment — HPLC systems, autoclaves, bioreactors, freeze dryers, centrifuges, analytical balances, temperature probes, and pressure gauges — has a calibration profile with interval, tolerance limits, calibration method, and responsible technician.
Calibration work orders are auto-generated on schedule. Before and after readings are captured inside the work order. Calibration certificates are stored against the equipment record. A compliance dashboard shows every instrument by status: In Calibration, Due Within 30 Days, or Overdue. When overdue, the system flags the instrument as out of calibration — preventing it from being used in production without documentation.
When a temperature excursion, humidity deviation, or cleanroom pressure differential failure occurs, Cryotos automatically generates a corrective maintenance work order with the alarm data embedded — creating the alarm-to-corrective-action traceability that FDA 21 CFR 211.68 and EU GMP Annex 1 auditors require.
Every maintenance deviation — missed PM, calibration failure, equipment used out of qualification — also triggers a CAPA work order. The CAPA is assigned to a named owner, tracked through 5 Whys root cause analysis, corrective action, preventive action, and effectiveness check. The full chain is timestamped and stored, satisfying FDA 21 CFR 211.192 investigation requirements.
Pharmaceutical engineering stores typically hold thousands of spare line items — and manual re-ordering based on visual stock checks is a production continuity risk. Cryotos integrates bi-directionally with SAP HANA. When a technician issues a part against a maintenance work order in Cryotos, the stock movement is reflected in SAP immediately.
When stock falls below the defined min/max quantity, Cryotos automatically creates a Purchase Requisition (PR) in SAP — no manual intervention required. Every part movement from MOQ alert to PR to PO to GRN to maintenance ticket consumption is traceable in a single reconciled record. The validated change control scope is limited to Cryotos as the receiving system, keeping your SAP validation impact minimal.
Full Feature Set
Immutable, timestamped records with individual user attribution. Electronic signatures on all maintenance completions. Role-based access prevents unauthorized modifications.
LIVE camera capture enforced — gallery uploads blocked. Before/after photos embedded with timestamp and GPS metadata. GMP-compliant photographic evidence on every task.
Cryotos participates in your Computer System Validation exercise. IQ/OQ/PQ protocol support and test evidence generation for regulatory submission packages.
52-week calibration calendar for all instruments. Before/after readings in work orders. Calibration certificates per asset. Out-of-calibration flag blocks unauthorized use.
Map every AMC contract, equipment certificate, and qualification document against assets. Automated expiry alerts weeks in advance. Never discovered during an audit.
Connect temperature, humidity, and differential pressure sensors in ISO-classified zones. Environmental excursion → auto corrective work order with full audit trail.
Missed PM, calibration failure, or environmental deviation auto-triggers a CAPA. 5 Whys root cause analysis required before closure. Satisfies 21 CFR 211.192.
Schedule PMs by time, meter reading, equipment usage, or multi-condition combinations. Mandatory photo evidence and digital checklists attached to every PM task.
Upload and manage SOPs, qualification documents, calibration certificates, and equipment manuals. Attach to specific assets. Technicians access on mobile during tasks.
QR-coded parts with bin, rack, and shelf tracking. ABC classification for critical MRO spares. Per-work-order consumption traceability. Auto-reorder on stock threshold.
Every spare part movement syncs in real time. Auto-generate SAP Purchase Requisitions when stock falls below minimum. Minimal validated change control scope.
Each pharmaceutical client's data is stored in a completely isolated AWS tenant. On-premise deployment available for sites with strict data sovereignty or network security requirements.
Built for Every Role
We will digitise your PM checklists, calibration schedules, and spare part register before your pilot begins.
Explore how Planys have encountered, 96% availability and reliability rate for assets, 25% reduction in critical breakdowns, and Enhanced operational efficiency after implementig Cryotos CMMS Software!
Alzain Farms LLC faced challenges with inefficient maintenance tracking, frequent equipment breakdowns, and manual processes. Explore how the firm overcome these issues and digitized their maintenance operations for real-time tracking and proactive scheduling.
I recently purchased Cryotos CMMS Software for asset management needs at my organization and after a few months of testing and monitoring, I'm incredibly pleased with the results. The software is user friendly, accessible and the design is very intuitive. It covers all the aspects of managing maintenance and repair, starting from preventive maintenance and standardizing operation cycles, to scheduling and streamlining workflows. I am highly satisfied with the performance and the range of features offered by Cryotos. Highly recommendable!
Read Review in G2Since we've started using Cryotos, our team has been able to stay on top of all the various SOPs. Checklists and safety procedures are now easily accessible to everyone, and we can quickly reference them whenever we need to. The software has definitely helped to improve our team's communication and efficiency. Plus, the fact that it's cloud-based means we can access it from anywhere, which is a big plus. It has been a great help in keeping everyone on the same page and up to date with the latest procedures.
I am using this application right now for my service team, very good, user friendly, have lot of customisation in workflow and service reports. the team supported for initial implementation, They have good support team. Myself fully recommended this application.
Read Complete Review in G2
