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Strategic Quality Management for Easy Compliance

Struggling withGxP compliance slowing delivery?recurring audit or inspection issues?quality/compliance expectations from your customers?

We design right‑sized quality management frameworks that keep your activities and projects compliant and efficient/agile. Reduce costly rework, de‑risk inspections/audits, and enable your teams to deliver with confidence.

Proven Quality Management expertise in Life Science (Pharma, Medical Device, IT Supplier Good Practices)

Inspection‑ready, risk‑based approach allowing to focus on what matters

Integrated Process covering Quality, Data & IT support

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Our Quality Management Services

Quality Management Support

Ensure quality without the pain.

We bring structure, expertise, and regulatory compliance to your processes so your operations becomes smooth, efficient and audit-ready. We support you in building up or enhance your Quality Management System according to relevant standards (e.g. ISO guidelines 9001, 13485, 27001, GAMP5, etc...). These processes can well be integrated in our eQMS.

IT Supplier Audits

Choose IT suppliers with confidence.

We help you formally audit potential Software Vendors, Cloud Service Provider and internal IT departments for you thoroughly, so you gain clarity, compliance and security from day one.

Audit & Inspection Support

Be inspection ready every day.

We uncover weaknesses early by performing Mock Audits and prepare your team to handle even the toughest audits with confidence.

Audit Trail Review

Conduct Audit Trail Review in a compliant way.

We design and build an Audit Trail Review process strategy that fits Data Integrity Guidelines and well integrated in your daily operations

Trainings

Auditor, Quality Management and GMP Audit Readiness, as well as Beginners and Advanced CSV Trainings.

External Quality Management

Keep the control of your operations even in absence of internal Quality Manager.

We take responsibility as External Quality support or Quality Assurance Manager to enable compliant operations and help you in day to day activities, e.g. CAPA management, Change and Incident Management, Create/Review new version of processes.

Related Services & Solutions

Here's where most of our clients go next:

MedDev eQMS

CSV & Testing

Trusted by Leading Laboratories

"Our collaboration with wega enabled us to easily implement and validate a very nice, user-friendly and affordable electronic quality management system compliant to ISO13485 and accordingly close a corresponding opened non-conformity. wega also consulted us on how to best document our Software Development in accordance with IEC62304 by leveraging Jira and maintain our technical documentation more easily.
wega also thankfully joined our ISO13485 surveillance audit in the absence of our QARA which was of great help to defend the proper setup of the QMS."

C. Morel, CEO, Axomove

Why wega for Quality Management

Expertise You Can Trust

Experienced Quality Assurance Management who know regulator expectations as well as Software Developer habits.

Quality That Accelerates Delivery

Right‑sized, risk‑based and agile practices that reduce effort, cut rework and avoid findings.

Support Across Every System & Team

wega bridges the gaps for smooth, compliant delivery across all departments/roles (QA, IT, Business, Data Science).

Ensure your pharma projects are compliant, efficient, and inspection-ready.

Let’s discuss how wega can strengthen your quality and validation practices.

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Knowledge Base

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When developing standalone medical device software or software that is part of a hardware medical device, it is essential to have control over your code.
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In analytical and industrial scientific research laboratories generation of comprehensive analytical data is a main purpose to serve scientific goals.
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Why You Should Prefer Modern Tools to Traditional Methods for Creating CSV Documents

This article looks at the benefits and challenges of introducing modern documentation tools for CSV and highlights their role in simplifying processes, reducing errors and improving traceability...
Past Events

wega Breakfast – Navigating CSV in a S/4HANA Brownfield Transition

05 Dec 2024 This presentation examines the approach Medartis AG adopted for Computer System Validation (CSV) during its SAP S/4HANA brownfield transition.
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Electronic Signatures in Laboratory Systems – Are the Regulatory Requirements Enough?

In an industry that relies heavily on precise documentation, strict compliance, and rigorous regulatory oversight, the implementation of electronic signatures represented a powerful leap forward.
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    Mathias

    Scrum Master
    Scrum Trainer
    Agility Coach

    Christophe

    Managing Director
    Board of Directors
    CSV & QA

    Evelyne

    Managing Director
    Senior Consultant
    CSV Specialist

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