Validated for compliance.
Designed for efficiency.
Manage 16 quality processes end to end with full traceability, electronic signatures, and controlled workflows. Designed in line with GMP/GxP principles and international requirements such as 21 CFR Part 11 and EU GMP Annex 11, and validated according to the ISPE GAMP 5 approach, QMex helps ensure quality from start to finish.
From deviation to audit: one chain
One-click CAPA from an audit finding; automatic pharmacovigilance from a complaint; training requirements from a document revision; end-to-end traceability with Related Forms on every record.
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01
Deviation Management
Class and target date auto-computed from Probability × Severity × Detectability; Release Approval decouples the batch decision from closure.
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02
CAPA
Work doesn't close by marking it done, QA verifies it through Completed-Action Approval.
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03
Change Control
Multi-branch evaluation; two-phase closure, Deployment Approval ≠ Closure.
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04
Training
Position-based training before the SOP goes effective; “Read & Understood” workflows.
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05
Audit
One-click CAPA from a finding; no finding closes before its CAPA, no audit before its findings.
16 modules. The same machine, wearing different forms.
Every module runs on the same workflow engine: e-form, status chip, e-signature, audit trail. Hover a tile to see what each module can do.
Deviation Management
Run deviations end to end: risk-based, fully traceable and e-signed, with batch/lot-controlled release, impact assessment and similar-deviation search.
CAPA Management
Manage CAPA integrated with audit findings and deviations; action management and effectiveness checks, aligned to multiple management systems.
Change Control
Run change control in a risk-based, controlled way, involving departments and regulatory affairs, with change ownership and change-board management.
Document Management
Manage documents across the whole lifecycle, from draft to e-signed approval and effectivity, with controlled electronic distribution, retrieval and destruction; parametric and GMP-aligned.
Training Management
Manage all training, from dynamic annual plans to employee training cards and qualification, with a flexible structure covering classroom and read-and-understand training, integrated with Document Management.
Customer Complaints
Handle customer complaints end to end: independent parallel investigations, interim and final responses, parametric impact assessments and CAPA integration.
Internal Audits
Digitalize internal audits with dynamic annual plans and parametric question sets; classify findings by impact score and manage them integrated with CAPA.
External Audits
Manage authority and customer audits with dynamic annual plans, Qualified-Person-routed closure and tracking aligned to multiple management systems.
Supplier Audits
Standardize supplier audits: dynamic annual planning, parametric risk assessment, impact-scored finding classification and easy tracking of supplier responses.
Work Follow-up & Action
Run company-specific processes over electronic forms, workflows and e-mail notifications, with every action tracked digitally and traceably.
Risk Management (FMEA)
Track risks at sub-category level with initial and residual scores; secure risk management with risk scales, mitigation activities and revisioned follow-up.
MBR Management
Manage the controlled electronic printing of released MBRs at one click, with reprint awareness and Document Management integration for safe, traceable production documents.
Artwork Management
Manage artwork and printed-material approvals end to end: parallel or sequential department reviews, multi-level approval and graphical PDF comparison between revisions.
Out of Limit Management
Track and report out-of-limit results by type with parametric phase assessments; keep the process controlled and traceable with root-cause analysis.
Pharmacovigilance Management
Manage adverse reactions, periodic safety reports and clinical studies with MedDRA-aligned forms and XML-based electronic regulatory reporting.
Supplier Qualification
Score suppliers with scope-based parametric criteria and departmental assessments; manage performance objectively with revisioned tracking and periodic review.
Not marketing. Mechanics.
These aren't brochure lines, they're the button, field and rule names on the actual screens.
A password at every step
Every transition passes through Take Action ▾: your choice, your password, your note. Nothing advances without the password re-entered; returns and cancels demand a mandatory reason.
Old value, new value, signature
Tools → History: the old and new value of every changed form field, who did it, date-time, note. E-signatures are listed separately under the “Signatures” heading.
Overdue work reports itself
System e-mails chase the deadline; if the work still slips, the matter climbs the ladder on its own, up to the responsible person's Department Manager.
Risk math is the system's job
You pick Probability, Severity and Detectability; the priority number, the class and the target closure date are computed by the system, no spreadsheet math.
“Progress is blocked.”
No closure with an open action, open finding or open pharmacovigilance form, the QMex rule engine
What a generic eQMS can't say
These aren't feature-list items, they're the product's own button and step names, with no equivalent in a generic eQMS.
A batch-release decision before the deviation closes: Affected Batches grid, “Locked?” flag and an e-signed release step of its own.
Change closes in two phases: first the deployment approval, then closure. The middle phase that vanishes on paper is a real step in the system.
Auto-spawned evaluation forms per licence group, a Variation Guideline clause picker and the gate: “no change without authority approval”.
When “the auditing body is a government authority” is ticked, closure approval routes to the Qualified Person automatically, with a mandatory closure letter.
Reasoned, controlled printing; per-copy delivery tracking; automatic timeout; and a Retrieval → Destroyed record for every copy.
Affected batches live on the deviation itself: “Affected? / Locked?” per batch, plus the Batch/Serial Synchronize action.
QMex, from your seat
“When the inspector walks in, can I show the evidence behind my signature in minutes, not days?”
In a government-authority audit, closure approval routes to you automatically. Your release decision is recorded with the affected batches and locks under e-signature. On every form: Tools → History → Signatures, who, what, when, why.
“The deviation pile keeps growing. Which action is late, who owns it, Excel can't tell me.”
One worklist: My Pending Work. Overdue actions escalate to the manager automatically; the system refuses closure while actions are open; target dates can't change silently, the deadline history is kept by the system.
“I only see quality risk when the audit report lands, and when a key person leaves, the process stops.”
Status, dates, overdue work and graphs live in the module reports; every grid exports to Excel and PDF in one click. Delegation and work transfer remove person-dependency, the process belongs to the company, not to one inbox.
Don't read it. Click it.
Try it live, pick Non-Conformance or CAPA from the QMex home screen and follow the guide at the bottom. Fictional data, no login, nothing to install.
Built for audit, not patched for it
Regulated quality is about evidence. Every QMex record carries who did what, when and why, in a form an auditor can read directly.
Electronic record and signature mechanisms designed to meet FDA 21 CFR Part 11 requirements.
Validated against the ISPE GAMP 5 lifecycle; the documentation is delivered to you, your CSV effort shrinks.
Computerised-systems controls aligned with EU GMP Annex 11.
Reliable, traceable data, the highest standard of data integrity.
Proven in operations. Proven in audits
QMex dramatically reduced paper across our QA documentation; data is now stored electronically and securely, with its full history and evidence. Being validatable to FDA 21 CFR Part 11 with end-to-end traceability made our process management significantly easier.
QMex is a powerful tool that lets us run our quality management processes more efficiently and effectively. It contributes greatly to traceability and data integrity, and remote access adds real flexibility to our workflows.
I first used QMex at my previous company and was very satisfied. At my current company I took an active role in its qualification, experiencing every stage of the Document Control, Artwork, Personnel and General Parameters modules, which raised my satisfaction even further.
We've been using QMex SaaS for a while and it truly made our processes far more practical. Easy to use, reliable, and a noticeable convenience in daily work. The team behind it is great too, always helpful and quick to answer. A system we would absolutely recommend!
Even though we moved our quality processes from a manual system to digital, the EIPICO team adapted to QMex in under six months. Fully meeting our data-integrity and ALCOA expectations, and compliant with FDA 21 CFR Part 11 and other regulations, QMex has made audits by different authorities easier.
For a quality management system to succeed, the right communication channels must connect every level and function of the company. Built on this principle, QMex lets us manage quality documentation, processes and approval stages electronically.
Frequently asked questions
What is QMex eQMS?
QMex eQMS is a fully validated electronic quality management system with 16 modules, built for regulated manufacturers. It manages deviation, CAPA, change control, document, training, audit and risk processes in one connected system where every record links to the next.
Is QMex compliant with FDA 21 CFR Part 11?
QMex's electronic record, electronic signature and audit trail mechanisms are designed to meet FDA 21 CFR Part 11 requirements. The system is validated against the ISPE GAMP 5 lifecycle and the validation documentation is delivered to the organisation. Compliance also depends on the organisation's own usage and validation practices, not on the software alone.
How many modules does QMex eQMS have?
QMex eQMS has 16 modules: Deviation Management, CAPA Management, Change Control, Document Management, Training Management, Customer Complaints, Internal Audits, External Audits, Supplier Audits, Task Tracking and Actions, Risk Management (FMEA), MBR Management, Artwork Management, Out of Specification, Pharmacovigilance and Supplier Evaluation. Every module runs on the same workflow engine.
Is validation documentation provided?
Yes. QMex is validated against the ISPE GAMP 5 lifecycle and the validation documentation is delivered to the organisation. This significantly reduces the organisation's own computerised system validation (CSV) effort.
What is the difference between QMex eQMS and QMex Forms?
QMex eQMS is a fully validated, 16-module platform covering the whole of regulated quality. QMex Forms focuses on designing e-forms and electronic logbooks without code; it is a lighter starting point for teams that want to move paper forms to digital quickly. Both sit under the same QMex roof.
Does QMex run in the cloud or on-premises?
QMex can be deployed either in the cloud or on the organisation's own servers, depending on need. The right deployment model is decided according to the organisation's data policy and regulatory requirements.