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Service · Digitalisation

Digital systems for your quality management.

Together with Normivo GmbH we offer powerful software solutions for document management (DMS) and enterprise resource planning (ERP) – specially for regulated industries such as manufacturers, wholesale, pharmacies and cleanroom laboratories.

What's in it for you?

What digitalisation delivers in concrete terms.

  • 30–50% less documentation effort.
  • Considerably faster SOP approvals.
  • Audit-ready evidence at the push of a button.
  • Structured CAPA and change-control processes.
  • Fewer manual sources of error.
Two solutions for your industry

Software designed from quality management.

In cooperation with Normivo GmbH we offer specialised systems for the pharmaceutical industry.

Document Management System (DMS)

For all industries – from pharmacy and wholesale to manufacturers and cleanroom laboratories. QM and electronic document control grow together. Workflows for deviations, CAPA and change control replace mountains of paper with digital processes.

ERP / merchandise management

For wholesale & manufacturers. All processes – from purchasing, production and warehousing through approvals and audit trail to analyses and invoicing – come together in one central, intuitive system.

One system instead of two applications. DMS and ERP are fully integrated – employees, roles and settings are set up only once and apply to both areas. No double maintenance, no separate logins.

Document management

Manage SOPs and processes digitally.

All quality-relevant documents, processes and records are managed and controlled centrally and digitally – for all regulated industries, from pharmacies and wholesalers to manufacturers and cleanroom laboratories.

Typical problems without a DMS

  • Outdated SOP versions in circulation
  • Unclear approvals
  • Manual training records
  • Stress during inspections

With our system

  • Versioning – automatic
  • Digital approval workflows
  • Training records at a click
  • Audit mode in minutes

Version control

Every version is captured and stored automatically – always clear which document is current and who last edited it.

Approval workflows

Documents are released once all required signatures are in place and records have been provided.

Online training

Training reaches all employees at the same time – with documented proof.

Deviations & CAPA

Deviations are captured paperlessly, corrective actions analysed and implemented systematically.

Change control

Changes are planned, approved and documented before they take effect.

Audit trail & data integrity

All changes are logged with timestamp and user – tamper-proof for authorities and inspections.

ERP / merchandise management

An ERP system that understands what you need.

Designed directly from the requirements of quality management – with integrated, GDP- and GMP-compliant QM functions for pharmaceutical wholesale and manufacturers.

Supplier & customer qualification

Check, approve and regularly monitor suppliers and customers efficiently.

Batch traceability

Track every batch from goods receipt to delivery with just a few clicks.

securPharm

securPharm checks managed clearly – from scan to documentation.

MSV3 interface

Seamless communication with all relevant systems in the market environment.

Goods receipt

Digital, structured and fully GDP-compliant goods-receipt inspection.

Stock & approvals

Stock overview, batch status and approval processes in view at all times.

ABDATA interface

Always up-to-date and valid medicinal-product master data.

Invoicing

Create the matching invoice directly for every goods issue.

Additionally for manufacturers

GMP manufacturing in the same system.

For your own production and contract manufacturing we extend the ERP with GMP-specific functions – seamlessly interlinked with goods receipt, warehousing and quality assurance.

Manufacturing & testing instructions

Maintain recipes, bills of materials and master batch records centrally and version-controlled.

Batch documentation

Electronic batch records – complete, traceable and inspection-proof.

Material status & quarantine

Raw materials and intermediates with status "quarantine", "released" or "rejected" – controlled via quality control.

QC test orders & specifications

Plan tests, capture results and automatically assess them against the stored specification.

Batch release by the QP

Release workflow with the decision of the Qualified Person (QP) and a complete audit trail.

Retain samples

Manage retain samples including retention periods and storage locations in a structured way.

Why QAdvance

We don't just implement software – we integrate processes.

  • We understand regulation.
  • We validate systems.
  • We support the rollout.
  • We think in processes, not just technology.

Your systems are validated to 21 CFR Part 11, GAMP 5 or GMP Annex 15 – meeting the highest regulatory requirements.

21 CFR Part 11 GAMP 5 GMP Annex 15
FAQ

Answers to the most important questions.

Does a DMS have to be validated?
Yes – as soon as the document management system supports quality-relevant processes (e.g. SOP approvals, training records or audit documentation), validation in line with GxP requirements is necessary. We support risk-based validation including URS, risk analysis, test documentation and release – practical and inspection-proof.
How long does a rollout take?
It depends on the starting point: for a new company, implementation is usually completed within 4–8 weeks. Integration into existing systems normally takes around 4–6 months. With structured project planning we ensure an efficient rollout without unnecessary strain on your day-to-day business.
Can existing systems be integrated?
Yes. In most cases existing systems such as merchandise management, temperature monitoring or training platforms can be connected. We assess the interface capability in advance and develop an integration concept that takes your existing IT structure into account.
What does a digital QMS cost?
The cost depends on system scope, number of users and validation effort. In addition to licence costs, implementation, training and, where applicable, validation should be considered. After a short needs analysis we are happy to prepare a transparent quote with a clear cost structure.
Is it GDP-/GMP-compliant?
Yes – the systems we implement meet the requirements of the EU GDP and EU GMP guidelines as well as relevant regulatory requirements (e.g. 21 CFR Part 11 where needed). Importantly: not only the system has to be compliant, but also its configuration and use. That is why we always combine system rollout with process consulting and validation.
Consultation

Ready for digital quality?

Let us show you how your processes can become more efficient – with a free system analysis.