Stay compliant with changing regulations and standards in a timely and efficient manner.
Maintaining strategic and financial control whilst meeting high quality and regulatory standards is both challenging and crucial for companies.
PlantVision consultants are specialists in regulatory compliance in the areas of pharmaceuticals, medical devices, veterinary medicine, and cosmetics.
We help you stay compliant with the latest regulations. Our quality services span the entire quality assurance area, covering data integrity, serialization, and risk analyses.
Our Compliance Team has broad knowledge in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), ISO 9001, ISO 13485, EU Medical Device Directives (MDD)/Medical Device Regulation (MDR), EU In Vitro Diagnostic Device Directives (IVDD)/In Vitro Diagnostic Device Regulations (IVDR), ISO 22716, US FDA Quality System Regulation (QSR), Good Automated Manufacturing Practice 5 (GAMP 5), and vigilance.
Our comprehensive approach ensures effective integration of information and systems. At the same time, process improvements lead to more efficient ways of working, cost savings, standardization, and less administration.
Companies need to make sure they can meet established requirements and continually monitor them to minimize the risks of becoming noncompliant. The issue is complex and affects many areas of the company, such as R&D, quality control, production, quality assurance, and information technologies.
PlantVision can help you manage comprehensive data integrity projects or offer specialized services that reinforce your organization wherever needed. Some examples:
- Planning and implementing operational strategies and project management
- Gap analyses and quality assessment
- Risk analyses
- Requirements management
We can support your change management process to comply with laws and regulations concerning your production flow. We enable you to meet specific market regulations more quickly and efficiently, ensure your systems and technology are compliant, prioritize actions, and make long-term operational improvements.
Our services include:
- Training », informational materials, and serialization guidelines
- Identification of needs, strategy, and supplier options
- Project management, from assessment through the bidding process to implementation
- Validation management
- Integration with existing equipment or systems and between suppliers
- Automation services
- Systems solutions for data storage
- Change management for new processes
- Quality assurance support
We are specialists in regulatory affairs and quality control affecting medical devices and in vitro diagnostic products.
Manufacturers developing safe and relevant products are required to adhere to a number of standards and regulations. Our consultants in this area can help you identify the specific requirements and standards that affect your product and make sure that the requirements for safety are ensured during development. We can establish test strategies, review your design, consult in incident reporting or help with whatever you need to make sure you are in compliance.
We offer services and solutions according to directives such as EU Medical Device Regulation/Medical Device Directive and In Vitro Diagnostic Regulation/In Vitro Diagnostic Directive, and standards like IEC 60601-1 and IEC 61010-1, ISO 14971 and other requirements and standards that specifically address product safety.
EU regulation 2016/679 of the European Parliament and of the Council, referred to as GDPR (General Data Protection Regulation), implies many changes, especially regarding how companies process and store personal data.
If you have customer, salary, or personnel databases, or if you otherwise process personal data on natural persons, or data that can be traced to a natural person, you need to comply with this regulation.
For example, to meet requirements you need to perform a dataflow analysis and describe the personal data that you process, explain the purpose of processing the personal data, and give reasons why you need to process the personal data. It is also important to describe how long you intend to save the personal data.
In addition to the various types of personal data, life science companies also need to consider information that is processed daily for meeting regulatory requirements, such as to ensure the traceability of activities (e.g. audit trails and electronic signatures for regulatory data). This is especially challenging as it affects both paper and electronic data processing.
PlantVision offers specialist consultation, project management, and training in GDPR »
We offer quality management services and solutions in compliance with ISO 22716 and regulation (EC) nr 1223/2009 on cosmetic products.
They fulfil the very high demands we place on our consultants, both in terms of competency and personal qualities.
Above all, I am very pleased with their ability to listen to our needs and then work independently to develop suitable solutions.
They identified crucial shortcomings during a supplier assessment. Their firm proposals made it easy to assess the prospects for future cooperation.
The training course provided a lot of valuable and concise information in a short amount of time. The course covered very relevant areas and the tutor was very competent. A very well thought-through and structured lecture.
Learn more about our Quality & Compliance offering
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