Every PM must trace to an approved SOP. Every breakdown needs QA sign-off. Every calibration reading needs a timestamp and user ID. ALCOA is the test your records must pass.
Cryotos replaces paper planners, undocumented breakdowns, and spreadsheet schedules with one GMP-ready platform your team actually uses.
Six Maintenance Risks That Fail Pharma Audits
Risk 01
21 CFR 211.67 requires written procedures for equipment maintenance — and records proving they were followed. A PM not documented against the correct SOP version is a deviation.
Paper planners can't version checklists, prove who completed each checkpoint, or flag a missed schedule before an auditor finds it.
Risk 02
"Show me evidence this cleanroom was cleared before the next batch." A signature on paper is a claim, not evidence.
For line clearance, equipment repairs, and area integrity checks, your team needs timestamped photos stored inside the work order — not gallery uploads.
Risk 03
"This equipment was serviced monthly. Now it's quarterly. Show me why." In most plants, the answer lives in a QMS the engineering team doesn't use. Without an approval trail on schedule changes, every frequency edit is a data-integrity gap.
Risk 04
FDA 21 CFR 211.68 requires instruments calibrated at suitable intervals with records maintained. A spreadsheet tracking 200+ instruments across multiple frequencies will miss a due date — with no easy way to prove the last calibration.
Risk 05
Good records are half of data integrity. The other half is proving they couldn't be changed without trace. Paper logbooks have no edit audit trail. Most generic tools don't log who deleted a work order or what the old value was.
Risk 06
Every part consumed during a repair must be traceable — material code, issuing store, receiving work order. Spreadsheets miss reorders and don't link parts to work orders. The equipment history stays incomplete and cost-per-asset is a guess.
Cryotos Solves All Six - In One Platform
In pharma, a photo must be taken at the time of work to count as GMP evidence. Gallery uploads let yesterday's photo pass as today's proof — a data integrity failure FDA auditors are trained to catch.
Cryotos enforces LIVE camera capture only. Every photo is taken through the app at the moment of work, with timestamp and GPS embedded. Gallery uploads are blocked.
21 CFR Part 11 requires electronic records to be attributable, time-stamped, and tamper-evident. Generic CMMS tools can't version checklists, enforce multi-department sign-offs, or capture structured QA decisions — the exact things pharma auditors check first.
Every PM checklist is built from your SOPs — versioned and locked automatically. For product-contact breakdowns, QA acknowledges before repair and verifies after with structured decisions on impact, cleaning, and re-qualification. Every stage carries a user ID, timestamp, and e-signature.
FDA 21 CFR 211.68 requires instruments to be calibrated at defined intervals with records maintained. A missed due date is an audit observation — and an out-of-tolerance instrument raises questions about every batch measured since the last good calibration.
Cryotos gives your calibration team a 52-week calendar with every instrument, frequency, and due date in one view. Technicians log before-and-after readings directly inside the work order. Out-of-tolerance readings are flagged immediately.
A temperature excursion in cold storage. A pressure breach in a cleanroom. Each triggers a deviation that must be investigated, corrected, and closed with evidence. If the corrective action lives in a separate system, proving the link between deviation and fix is difficult.
In Cryotos, when a deviation is logged, the system generates a CAPA work order automatically. The technician documents root cause using 5 Whys directly in the work order. CAPA closure requires verification sign-off. Area-based PMs — cleanroom walls, coving, floors, drains — run on the same engine as equipment.
In pharma plants running SAP, every part consumed must be traceable — material code, issuing store, receiving work order. The repair record feeds equipment history and the batch record.
Cryotos connects bi-directionally with SAP HANA. When a technician issues a part, the material code and quantity are captured. When stock falls below your defined minimum, Cryotos generates a purchase requisition in SAP automatically — no manual PR, no delay.
Full Feature Set
Every action logged with user ID, timestamp, and reason. ALCOA+ principles — Attributable, Legible, Contemporaneous, Original, Accurate — built into how every record is stored.
LIVE camera capture enforced — gallery uploads blocked. Timestamp and GPS metadata embedded. Before/after photos on every task.
Cryotos participates in your Computer System Validation. Protocol templates and test evidence provided for qualification.
52-week calendar for all instruments. Before/after readings in work orders. Certificates per asset. Out-of-tolerance flag on breach.
Map AMC contracts, certificates, and qualifications against assets. Auto-alerts weeks before expiry — never discovered during an audit.
Connect temperature, humidity, and pressure sensors in ISO-classified zones. Excursions auto-trigger corrective work orders with full audit trail.
Missed PM, calibration failure, or environmental deviation auto-triggers a CAPA. 5 Whys root cause required before closure. Satisfies 21 CFR 211.192.
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Schedule PMs by time, meter, usage, or multi-condition triggers. SOP-versioned checklists and mandatory photo evidence on every task.
SOPs, qualification docs, calibration certificates, and OEM manuals — attached to assets, version-controlled. Technicians access on mobile during tasks.
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QR-coded issuance with bin/rack/shelf tracking. ABC classification. Per-work-order traceability. Auto-reorder on threshold.
Spare part movements sync in real time. Auto-generate SAP PRs when stock hits minimum. Minimal change control scope.
Isolated AWS tenant per client — no shared database. On-premise deployment available for strict data sovereignty requirements.
PM frequency changes go through an approval workflow with reason and change-control reference. Rejected changes stay on file, not deleted.
Pending-with-reason, short-close-with-reason, send-back-for-rework, and reassignment log. Every miss documented, not hidden.
Deletion restricted to administrators; every deletion backed up. All edits to assets, schedules, and users stored as old → new value.
Digital permits for high-risk maintenance with isolation and de-isolation steps. Technician confirms applicable safety certificate before the job starts.
QA acknowledges before repair, verifies after with structured decisions on impact, cleaning, and re-qualification. Every unplanned stop logged with duration, root cause, MTTR, and MTBF.
Full work order access on mobile with offline mode. QR scanning for instant asset ID. Create, assign, and track corrective and preventive work orders.
Pharma Maintenance Guides
Inspectors ask for PM schedules, completed records, breakdowns since the last batch, and change control behind every frequency edit. This guide covers the full compliance stack — ALCOA+ in work orders to the 5-step inspection-day playbook.
Pharma PM is scheduled, evidenced, SOP-versioned work. This guide covers the 5-stage work order flow, QA-gated breakdowns, and facility area checks that separate GMP maintenance from ordinary PM.
Maintenance says the line runs fine. Quality says batches fail. Both argue from different spreadsheets. This guide covers how a pharma CMMS unifies uptime and compliance — and why TPM fades after year one without it.
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
