EU GMP · FDA · Pharma QC · Equipment Qualification
Every activity.
Traceable at any time.
In pharma QC labs, equipment status, maintenance, qualifications, and technical events must be traceable at all times. LabThunder consolidates this information centrally and ensures important records are quickly available both in daily work and during audits.
Trusted by
GMP/GLP
ISO 15189
ISO 17025
Important to understand: LabThunder is not a LIMS and not an eQMS - it fills the gap that both leave behind. Your LIMS manages samples and results. Your eQMS manages deviations and CAPAs. LabThunder manages the equipment itself: qualification status, logbook, error history, manuals - exactly what's most often missing during GMP inspections.
„The HPLC system's requalification was three weeks overdue. Nobody had an automatic reminder. The equipment kept being used. The FDA inspector finds it. Critical finding."
Overdue requalification - equipment kept in use
In pharmaceutical QC laboratories, all analytical equipment must be qualified per GMP regulations and maintained in that qualified state. IQ, OQ, PQ, periodic requalification - all must be demonstrably documented. An overdue piece of equipment still in use is a critical GMP finding.
Equipment qualification · AIQ · GMP critical finding
„An OOS result from HPLC analysis. The investigation begins: was the equipment calibrated? Were there similar deviations before? The error history exists in three different folders - and nobody knows where record no. 2 from 2022 is."
OOS investigation with no findable error history
In an OOS result, the laboratory investigation must be fully documented. This necessarily includes reviewing the equipment status. If the error history isn't instantly retrievable, the OOS investigation is significantly delayed - and the batch stays on hold.
OOS · OOT · Error history · Batch hold
„The QP can't release the batch. The scale's calibration certificate expired yesterday. The document? Somewhere in a folder, somewhere on the network drive. Production is waiting. Every hour costs money.."
Batch release blocked due to missing equipment documentation.
The Qualified Person (QP) bears regulatory responsibility for every released batch. If even a single piece of equipment documentation is missing - calibration certificate, requalification record, maintenance proof - the batch cannot be released. Production downtime per hour: significant.
Batch release · QP · Calibration certificate · Production stop
„New employee Ms. Meyer has been working in the QC lab for four weeks. The training record for the HPLC system was never documented. The GMP inspector asks about it. Finding."
Missing training record - classic inspection finding
GMP requires that anyone operating a device be demonstrably qualified and trained. Training records must be complete, up to date, and instantly retrievable. When staff change, methods are updated, or equipment is upgraded, training documentation must be kept current immediately.
Training record · Competence · GMP inspection · EU GMP
„The paper logbook at the device is updated daily - in theory. In practice: entries are filled in retroactively, sometimes on Friday evening for the whole week. Not because employees are careless - but because the logbook is an extra step wedged between the measurement and the office. The inspector calls it "lack of contemporaneous documentation.."
Documentation as a GMP obligation instead of a tool - the root problem
GMP inspectors know this pattern well: logbooks formally exist, but entries aren't made in real time, aren't complete, or were added after the fact. "Contemporaneous documentation" - recording things as they happen - is a fundamental requirement. LabThunder makes this possible: entries made directly at the device, in seconds, because the system immediately gives something back to the employee - the complete equipment history, OQ status, next calibration date. Documentation shifts from a GMP obligation to a useful tool. The result: more documentation, better quality, complete traceability - as a byproduct of everyday work.
Contemporaneous documentation · GMP inspection · Audit trail · Compliance as a byproduct
The common denominator of all GMP findings
It's not the error itself that becomes the problem.
It's the lack of traceability.
It's the lack of traceability.
Many GMP findings in QC labs don't arise from serious quality problems, but because information is missing, documented too late, or unfindable at the critical moment. LabThunder makes documentation a natural part of the workflow - simple, direct, and traceable.
70%
less documentation time
100 %
compliant
1
central platform
The Solution · LabThunder for Pharma QC
GMP-compliant from day one.
Because good documentation shouldn't mean extra work.
LabThunder closes the gap between LIMS, eQMS, and everyday lab work - with centralized equipment documentation and readily available lab knowledge.
Qualification status of all devices - at a glance
IQ, OQ, PQ status, next requalification, and calibration certificates – all centrally tracked for every device. Overdue qualifications are flagged in good time. No more devices running unchecked outside of their qualified state.
GMP-compliant equipment logbook with audit trail
Every entry is timestamped, immutable, and assigned to the user. This fulfills the requirement for "contemporaneous documentation," as entries can be made directly on the device in seconds. No more backdating.
Device history via QR code - available immediately at OOS
OOS result? Scan the QR code → get instant access to: complete error history, latest calibration certificate, qualification status, and the last user. Complete your Phase 1 OOS investigation in minutes instead of hours.
Training records directly on the device
Who was trained on which device and when? Tracked directly in the system and linked to the equipment, it’s instantly verifiable. No more separate training folders. When a GMP inspector asks, you have the answer in 10 seconds.
Thunder AI - Instant access to device knowledge
AI trained on your manuals, SOPs, and error logs. "How do I clean the GC-MS ion source according to our SOP?" – Get answers in seconds, sourced directly from your own documents. Fewer follow-up questions, fewer errors, and fewer service calls.
Audit-ready at all times, not just before the audit
All equipment records are complete, centralized, and instantly exportable. When an FDA inspector asks for the 2022 qualification protocol for HPLC-3, your answer is immediate. Not tomorrow, not after a long search.
What LabThunder is - and what it isn't.
LabThunder is not a replacement for your LIMS (samples, results, batch records) or your eQMS (CAPAs, deviations, change control). It closes the equipment documentation gap that both leave behind: qualification status, equipment logbook, error history, training records, manuals - everything related to the device itself, which is what most often turns into a finding during GMP inspections. LabThunder runs alongside your LIMS and eQMS - with no conflict, no IT project required.