One 483 observation can slow you down.Your Preventive Maintenance records shouldn't be the reason.
FDA inspectors document what they can't verify. Pruved seals every Preventive Maintenance execution the moment it's completed: technician, timestamp, SOP revision in effect, step by step. Unambiguous. Audit-ready.
In 30 minutes we review your current practices, map any open observations, and assess where your documentation stands.
30 minutes · review your current practices · map open observations or gaps
Nearly 1 in 6 FDA 483s cites a preventive maintenance gap. Most were preventable.
What investigators actually write
Common observations across FDA 483, CDSCO Schedule M, and EU-GMP inspectionsNo written SOP for equipment cleaning and maintenance
Investigator finds no procedure defining how Preventive Maintenance is performed or documented.
Preventive Maintenance records do not demonstrate equipment operates within established limits
Logs show tasks were completed but contain no measurements, readings, or evidence of acceptable performance.
Equipment log entries are incomplete, missing, or not contemporaneous
Records were written after the fact or left fields blank. Timestamps do not match observed work.
Electronic records lack audit trail or are not attributable
System allows backdating, overwriting without trace, or has no individual user attribution per entry.
No backup or verification that maintenance did not affect product quality
After Preventive Maintenance activity, there is no documented verification that equipment was returned to qualified state.
Written Preventive Maintenance schedules not followed; deviations not documented
Preventive Maintenance was performed outside the scheduled interval with no documented justification or deviation report.
Maintenance records do not identify the person who performed the work
Schedule M requires every maintenance record to capture the identity of the technician and a description of work performed. Unsigned or anonymised logs fail this requirement.
Electronic equipment records lack an audit trail and cannot be attributed to a specific operator
EU-GMP Chapter 3 and Annex 11 require that electronic records be attributable, accurate, and protected against undisclosed alteration. The same data-integrity gap cited under 21 CFR Part 11.
.pruved, one file, complete audit readiness for preventive maintenance.
Every step.
Every signature.
Sealed.
Build the Preventive Maintenance procedure as a structured digital protocol: steps, required evidence types, acceptable ranges, and the SOP revision it references.
The technician follows the protocol on-device. Readings, photos, and timestamps captured in real-time as the work is performed. Nothing is written up afterward.
Supervisor reviews the full executed sequence and applies a 21 CFR Part 11 electronic signature. The sealed .pruved file is sent to the investigator.
The investigator opens the .pruved file in Pruved Player. Every step of the Preventive Maintenance cycle replays in sequence with all captured evidence and a verified chain of custody.
Build the Preventive Maintenance procedure as a structured digital protocol: steps, required evidence types, acceptable ranges, and the SOP revision it references.
The technician follows the protocol on-device. Readings, photos, and timestamps captured in real-time as the work is performed. Nothing is written up afterward.
Supervisor reviews the full executed sequence and applies a 21 CFR Part 11 electronic signature. The sealed .pruved file is sent to the investigator.
The investigator opens the .pruved file in Pruved Player. Every step of the Preventive Maintenance cycle replays in sequence with all captured evidence and a verified chain of custody.
.pruved file+Pruved Player
A complete replay of the preventive maintenance cycle with tamper-evident, forensic-grade evidence.
Available on macOS + Windows
What prospects ask on every review call
Find out where your Preventive Maintenance program stands
before the next inspection.
For QA directors and compliance leads at FDA, CDSCO, and EU-GMP regulated pharmaceutical manufacturers. We review your Preventive Maintenance documentation posture and show you exactly what changes.
What happens in the review
We map your current Preventive Maintenance documentation against the specific 483 observations that apply to your facility type.
We walk through a live .pruved record so you can see exactly what an inspector would receive.
You leave with a clear picture of your exposure and whether Pruved closes it.
30 minutes. No sales deck.
Beyond the Checklist
Maintenance evidence isn't just a compliance problem.
It's a knowledge problem.
Practical writing on GMP documentation, ALCOA+, CFR Part 11, and what audit-ready maintenance actually looks like in regulated environments.