Strategic and efficient quality assurance is essential to an organization’s continued success. This applies to all areas, whether you are developing new pharmaceuticals or processes, or carrying out improvement projects.
Maintaining strategic and financial control whilst meeting high quality and regulatory standards is both challenging and crucial for companies.
We offer a wide range of quality services, covering pharmaceuticals, medical devices, and cosmetics. We help you to stay compliant with the latest regulations whilst meeting project and business goals with an optimal use of resources.
Our Quality Management team is made up of quality assurance specialists with extensive experience in the life science industry. We can provide specialized services or collaborate as your quality partner, as well as providing a QA HelpDesk service.
QUALITY MANAGEMENT SYSTEMS
Our consultants can assume full responsibility for major improvement projects in quality management and quality management systems, or they can carry out specific tasks in a number of areas. Whatever the role, we always take a comprehensive view to ensure effective integration of information and systems.
- Quality management systems (QMS), construction, implementation, and maintenance * Assessment and release by a qualified person (QP), evaluation of serious deviations, change management, and corrective and preventive action (CAPA)
- Product quality reviews (PQRs)
- CAPA processes and deviation management, design, and execution
- Change management, design, and execution
- Quality assurance for different purposes, such as project QA, QA computerized systems, and QA in product-development projects. We have QA specialists in areas such as pharmaceuticals, medical devices, and cosmetics.
- Complaints handling, claims and refunds, including design and execution
- Quality assurance in projects, programs, software
- US Food and Drug Administration’s Title 21 CFR Parts 820 and 11, ISO 13485, ISO 9001
- Good manufacturing practices (GMP), good distribution practice (GDP), good laboratory practice (GLP), good pharmacovigilance practices (GVP)
- Regulation (EC) N° 1223/2009 on cosmetic products
We can help you to establish a pharmacovigilance system, compliant with regulatory requirements affecting your business.
- Issuing standard operating procedures (SOPs)
- Issuing and updating a pharmacovigilance site master file (PSMF)
- Daily management of side effects
- Providing a qualified person (QP) responsible for pharmacovigilance (QPPV) and a deputy QPPV on 24-hour, 7-days-a-week availability
- Market intelligence/surveillance activities
- Periodic safety update reports (PSUR ) and postmarket surveillance (PMS)
- Risk management planning (RMP)
- Training in pharmacovigilance
- Subscription service, including a subscription for updates of specific regulations and assistance in interpreting how changes in regulations affect your operations
- Internal reviews, including internal review of the pharmacovigilance system, and support and advice before, during, and after external inspection by a governmental authority or customer
DATA INTEGRITY ASSURANCE
Increased regulatory focus on data integrity is affecting all areas of life science. Systems that generate data are subject to intensive review. Electronic and paper-based data need be consistent in meetingstandards and regulations throughout their entire lifecycle.
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
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.
GAP & RISK ANALYSES
We help you to analyze challenges and opportunities from a risk-management perspective, based on clear strategies and consultation. This approach enables you to raise your level of quality, shorten lead times, and lower your costs.
Our Compliance Team also has knowledge and capabilities covering regulations and quality management issues affecting cosmetics.
We offer quality management services and solutions in compliance with ISO 22716 and regulation (EC) nr 1223/2009 on cosmetic products.