Quality assurance & QMS

Effective Quality Assurance is about more than compliance and how it is implemented. We have helped clients with everything from building an entire quality management system from the ground up to supporting and advising on a specific step. It's about finding the right way of working that lasts over time to deliver safe and effective products to the market.

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Quality assurance that builds stability and direction

With solutions tailored to conditions and needs, it is possible to build a structure that supports day-to-day operations, reduces the risk of bottlenecks and makes quality work robust. Whether the need is for gap analysis, document review, quality control (QC), release or building QMS/eQMS, the systematic and risk-based approach is crucial. It ensures that the product is fit for intended use.

Customized QMS

A quality management system that complies with requirements while being adapted to your business.

More efficient processes

Reduced administration through clear flows and useful documentation.

Support at crucial moments

Review of computerized systems, management of CAPA, SOPs and release.

Systematics for growth

Quality assurance and quality systems that support both current and future business needs.

Varför Plantvision

Hur vi gör skillnad

Industry-leading expertise & experience

Deep understanding of Life Science, with experience in Pharma, Biotech, Medtech, and Healthcare.

Holistic approach

We support the entire project lifecycle from concept and development to implementation and follow-up.

Flexibility in methods

The combination of proven ways of working and tailored solutions makes us adaptable to any need, from the start-up to the global organization.

Effective results

Through experience and a clear structure, we save time, resources and ensure a safer implementation of projects.

Insights

What thoughtful quality assurance brings

Selected customers in Quality Assurance & QMS

Our services in Quality Assurance

Quality management
system

Creating a quality system that meets regulations and standards is relatively easy. However, to succeed in developing a quality system that is both compliant and adapted to your business, which becomes a support instead of an obstacle, is anything but trivial. With the right skills and support, both implementation and, above all, usability will be optimal.

Release

Whether for Pharma, Medtech or other GxP-regulated products, we ensure that the release is safe, traceable and properly documented. The service is tailored to your needs, from temporary support during work peaks to longer-term QA assignments.

Non-conformity management

Managing non-conformities is crucial to maintaining systematic quality work. By identifying recurring patterns and root causes, you can prevent major errors before they have consequences. We help you with a clear and consistent approach that makes the process of capturing, investigating and following up on non-conformities as smooth as possible.

Risk management

Risk management is one of the cornerstones of quality assurance, whether in development, manufacturing or change management. We offer operational and strategic support in risk management within both GxP and ISO 14971. Everything from early development to finished product, from process to change management.

Audits and reviews

Audits are a requirement and a tool to build resilience and improve your business. Whether it's internal audits, supplier audits or preparation for regulatory inspections, we provide methodology, industry insight and the right depth and expertise in regulations such as GxP, MDR, IVDR, CFR, MDSAP and others.

Project QA

One of the cornerstones of successful projects is to have a QA with the right skills and understanding of both business requirements and conditions. Our experienced QA can support you in several different projects - with deep expertise, broad experience of different types of businesses and a sensitivity to the organization, they will be an addition to your delivery.

Always with Plantvision

Compliance partner

Our Compliance Partner service gives you access to the expertise you need most, in the right Location, at the right time.

Project Management

Projects that really deliver on next level level change management from start to finish.

Plantvision

With our Academy, we offer relevant and Customised courses that meet both today's and tomorrow's needs in Life Science.

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