Customer QRQC
Handle customer complaints end to end: identification, 5W2H, quick response, root-cause analysis, action plan and 8D report.
Quality System
From deviation to inspection, quality excellence.
The quality management platform — non-conformities, analyses, action plans and lessons learned — brought together with rigour and clarity.
BPF / GMP
ICH Q9 · Q10
21 CFR Part 11
EU Annex 11
22Modules
14Pharmaceutical modules
9Languages
100 %Data traceability
Modules
A module for every quality flow
One problem-solving method, adapted to each domain: every module follows a guided path, with attachments, before / after photos and PDF exports.
Supplier QRQC
Manage supplier non-conformities: sorting, 8D analysis, action plan and closure, linked to the lessons-learned card.
People Quality
Map skills: employee × skill matrix, expected and actual levels, supporting documents by domain.
Production QRQC
Raise and solve production deviations in five steps: characterisation, securing, quick analysis, quick action, validation.
Safety QRQC
Report and analyse incidents and at-risk situations, issue the safety alert and follow the action plan through to closure.
LLC & Rex
Capitalise on lessons learned: characterise, learn, share, standardise, communicate and close.
BI Portal
Quality dashboard: volumes, closure rate, lead times, on-time actions, recurrence and Pareto, with PDF and Excel export.
Admin
Administer users, roles, reference data, languages, translations, edit locks and traceability.
Change Control
Control every modification: request, impact assessment, approval, implementation and effectiveness check, through to closure.
Pharmaceutical industryCAPA Register
Centralise corrective and preventive actions: source, root cause, action plan, due dates and effectiveness check.
Pharmaceutical industryAudit & Inspection
Plan and follow your audits and inspections: classified findings, responses, linked CAPAs and PDF report.
Pharmaceutical industryDocument Control
Control your quality documents: versions, review, approval, distribution, periodic review and read-and-understood.
Pharmaceutical industryOOS / OOT Investigation
Manage out-of-specification and out-of-trend results: phase I laboratory check, phase II full investigation, retests, conclusion and batch disposition.
Pharmaceutical industryProduct Recall
Run a batch recall or withdrawal: risk assessment, classification, notification of authorities and consignees, quantity reconciliation.
Pharmaceutical industryBatch Release
Process the release of each batch: review of the batch record, deviations and test results, then decision and certification by the qualified person.
Pharmaceutical industryQuality Risk Management
Carry out your risk analyses (ICH Q9): FMEA with calculated criticality, control measures, residual risk and periodic review.
Pharmaceutical industryEquipment & Calibration
Keep your equipment register: IQ / OQ / PQ qualification, calibration and maintenance plan, intervention history and due-date alerts.
Pharmaceutical industryValidation
Manage the validation lifecycle: protocol, test runs, report, conclusion and maintenance of the validated state with planned revalidation.
Pharmaceutical industryGMP Training
Plan and trace trainings: sessions, attendance, assessment of learning and effectiveness verification.
Pharmaceutical industrySupplier Qualification
Qualify and monitor your suppliers: risk assessment, questionnaire, audit, quality agreement, approved supplier list and performance reviews.
Pharmaceutical industryManagement Review
Prepare and record your management reviews: quality system indicators, decisions, actions and system effectiveness.
Pharmaceutical industryProduct Quality Review
Carry out the annual quality review of each product: batches, deviations, OOS, changes, complaints, stability, with pre-filling from system data.
Pharmaceutical industryMethod
A guided path, from declaration to closure
Declare
Guided entry, by voice or keyboard, with photos and attachments from the very first step.
Analyse
Containment, root causes and risk assessment using the method suited to the domain.
Act
Corrective and preventive actions with owners, due dates and overdue alerts.
Close and sign
Effectiveness verification, electronic signature and locking of the record.
Pharmaceutical industry
Built for the rigour of a pharmaceutical quality system
From a manufacturing deviation to the quality review, QualiGold structures the handling of non-conformities, CAPA and lessons learned along the logic of a pharmaceutical quality system (GMP).
01
Deviations
Immediate reporting, containment, investigation and closure, with lead-time and recurrence tracking.
02
CAPA and effectiveness
Corrective and preventive actions with owners, due dates and effectiveness checks.
03
Monitoring and reviews
Closure rate, lead times and recurrence for periodic quality reviews and management review.
From the shop floor to the quality system
- Deviation in productionProduction QRQC: characterisation, containment, root-cause analysis, CAPA, management validation.
- Customer complaintCustomer QRQC: quick response, analysis, action plan, 8D report and closure with lessons learned.
- Supplier non-conformitySupplier QRQC: sorting, supplier 8D, action follow-up and linked lessons-learned card.
- Process or equipment changeChange Control: request, quality and regulatory impact assessment, approval, implementation and effectiveness.
- Audit or inspectionAudit & Inspection: classified findings, responses and CAPAs generated from major findings.
- Effective procedureDocument Control: versions, periodic review and proof of read-and-understood.
- Periodic quality reviewBI Portal: indicators filterable by period and module, PDF and Excel export.
Designed to support — GMP (EU), ICH Q9 and Q10, 21 CFR 210 / 211, EU Annex 11 and 21 CFR Part 11.
QualiGold provides traceability and access-control functions; qualification and validation of the computerised system in your context remain the operator's responsibility.
Cross-cutting features
Designed for everyday compliance
Electronic signature
Re-authentication at every signature, meaning and timestamp recorded, record fingerprint, locking after approval and a tamper-evident log.
Voice dictation
Dictate your findings into the microphone, in the interface language: spoken punctuation is recognised.
Translation on demand
Data stays in its original language; a button offers translation into the language of your choice, never imposing it.
Attachments and photos
Checked files (type, size, content), stored privately and attached to each step of the record.
Cockpit and indicators
Delays, due dates and priority records, quality dashboard and PDF and Excel exports.
Full traceability
Audit trail of every change, access by role, by module and by client, two-factor authentication.
Security and compliance
Trust is shown, and it is proven too.
Every action is attributed, time-stamped and kept. Each client has its own database, isolated from the others.
- Database isolated per clientNo mixing of data between clients.
- Two-factor authenticationOne-time code in addition to the password.
- Fine-grained rights per moduleView, create, edit, delete, sign, cancel a signature.
- Tamper-evident logChained signatures, verifiable at any time.
- Private filesNever public, served only after rights are checked.
- Abuse protectionAttempts at signing and translating are rate-limited.
Multilingual
Ready to put quality at the heart of your operations?
Interface and reference data available in 9 languages: French, English, Italian, German, Spanish, Portuguese, Polish, Danish and Chinese.