GMP | ISO13485 | ISO9001 | QMS

Do you need to update your quality system, write new policies, procedures or instructions?

QualityVision has in-depth and broad experience with various electronic QMS systems.

Audits

Do you need to have an internal audit or supplier audit carried out?

Quality Vision is certified Lead Auditor and has conducted numerous audits in both Denmark, EU and rest of the world.

Corrective & Preventive Actions | Change control

Do you need an extra resource to optimize or implement process changes?

QualityVision has experience with elaborated corrective & preventive actions as well as documented change control.

Validation | Qualification | URS | Commissioning

QualityVision offers a wide range of services within validation and qualification.

QualityVision has 20 years of experience with validation in the life science industry (product, process, method and software).

• Risk Management e.g. DFMEA, PFMEA, HAZOP, FTA, PHA, GxP assessment
• Commissioning, URS, FAT and SAT
• IQ, OQ PQ and PV

Risk Management

In the risk management process it is often necessary to use several types of tools to uncover all relevant risks.

QualityVision has extensive experience with this and can, among other things. offer internal training at various levels of User, Design, Product and process FMEcA, HAZOP, FTA, PHA, GxP assessment.

Education & Courses

Do you need specialized training of your key employees and / or more groups of staff?

Since 2005 Quality Vision completed numerous courses and hands-on training in various Life Sience companies.

QualityVision organizes teaching in relevant topics within several areas of authority.

All lessons can be organized according to internal procedure.

Good Documentation Practice | ALCOA | Data Integrity

Does your company have a need for updating of documents dealing with good documentation practices?

QualityVision can offer updating of documents in accordance with applicable legal requirements as well as training of the company's employees at several levels.

Project management | Resource person

Does your company need a project manager or a resource person for a shorter or longer period?

QualityVison can offer project managers or resource persons for your projects.

Supplier management

In recent years, there has been much more focus on suppliers and their management and the requirements have increased.

QualityVision knows these requirements and can therefore help companies and suppliers in this process.