A researcher working in a laboratory

Quality management for life science

Quality management system for life science, ready for GMP

Centuri is a quality management system for life science that brings SOPs, training, non-conformances and quality agreements together with full traceability, so you're ready when Läkemedelsverket (the Swedish Medical Products Agency) inspects.

  • Controlled SOPs with read acknowledgements and versions
  • Training linked to governing documents

Last updated: 4 November 2026

Market-leading customer satisfaction according to Business With 2026

Boule
Campus Pharma
Optinova
Elypta

Requirements in life science

What are the quality system requirements in life science?

Companies that manufacture medicines or medical devices must follow GMP and be able to demonstrate it when Läkemedelsverket inspects. Medical device companies also often work to ISO 13485.

GMP: Controlled documents and data

SOPs must be approved, version-controlled and traceable, and data must be reliable.

Training: The right training on the right version

Staff must be trained on the current version before they work to it.

CAPA: Non-conformances and corrective actions

Non-conformances must be investigated and corrected, and their effectiveness followed up.

How Centuri helps life science companies meet the requirements

What happens when an SOP changes?

An example: a cleaning procedure in production needs to change. Here's how the change is handled in Centuri, from proposal to trained staff.

  1. Change. The owner makes the change in a draft. The current version stays in effect until the new one is approved.
  2. Review and approve. Reviewers and QA approve in a controlled workflow, and every step is logged.
  3. Publish. The new version is published, and the previous one is kept in the history.
  4. Train. Affected staff receive the training and acknowledge it. You see straight away who has completed it.
An SOP change in Centuri with the steps change, review and approve, publish and train, and training status per employee

Centuri AI

Find what you need in your documentation

Centuri AI answers questions about your SOPs based on your own approved information, and summarises non-conformances and CAPA cases. That makes it faster to find the right procedure and spot patterns over time.

Centuri AI answers which cleaning SOP applies to line 2 and cites the approved source documents

Centuri meets the high demands for validation and traceability that the medical device industry sets. It gives us the control we need.

Oscar JäderlundGroup Quality and Material Compliance Manager, Optinova

Customer case Optinova

The same control in every unit

Optinova, which makes medical tubing for customers in more than 35 countries, manages quality and traceability across the whole group from one system.

3

Countries with production. Optinova has production in Finland, Thailand and the USA, all in the same system (Optinova).

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Units in one system. Optinova's six units all work in one and the same Centuri (Optinova).

Want to see what it looks like ahead of an inspection?

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Why Centuri

Why quality managers choose Centuri

Compare Centuri with: SharePoint · CANEA · Addsystems · AM System

Make changes yourself, without consultants

Centuri is no-code. You build workflows, forms and templates yourself instead of buying consultancy hours.

AI across the whole platform

Centuri AI summarises, analyses and answers based on your own approved information, in every module.

Hosted and stored in Sweden

The platform runs in Sweden, without exposure to the US CLOUD Act. Your data never leaves the EU/EEA.

Customers who stay

Market-leading customer satisfaction according to Business With 2026. Aleris has been a customer for 20 years.

Questions about quality management systems for life science

Does Centuri support GMP requirements for document control?

Centuri manages SOPs and other governing documents with review, approval, versions and read acknowledgements. Every change is logged with date and owner, and previous versions are kept. This gives you the traceability GMP requires. We'll go through how you validate the system for your operations in the demo.

How is CAPA handled in Centuri?

Non-conformances are investigated to the root cause in the same workflow where they're reported. Corrective and preventive actions get an owner and a due date, and effectiveness is followed up before the case is closed. Centuri sends reminders until the action is done, and everything is kept with its history for inspection.

Can we show that staff are trained on the right version of an SOP?

Yes. Training is linked to governing documents in training management. When an SOP changes, affected staff receive the training, and you see straight away who has acknowledged which version. That makes it easy to show training status to an inspector or auditor.

How does traceability work during an inspection by Läkemedelsverket?

All changes to documents, non-conformances and actions are logged with date and owner. You can show which version applied at a given time, who approved it and who was trained. The evidence is in the same system, so there's nothing to gather before the inspection.

Can we manage quality agreements with suppliers?

Yes. In contract management, you keep quality agreements and other agreements with suppliers and contract manufacturers in one place. Centuri reminds you before an agreement is due for review or renewal, and agreements can be linked to the supplier's non-conformances. This gives you an overview for supplier assessments and inspections.

See how Centuri gets you ready for inspection

Here's what happens when you book a demo.

1. Book a time. Choose a time that suits you. The demo takes 30 minutes.

2. See Centuri for your needs. We show you the parts of the platform that meet your needs.

3. Get a proposal. You receive pricing and a plan for getting started. Initial implementation takes 4-8 weeks.