Stay compliant and strengthen your laboratory operations through a fully integrated quality system.
Quality systems in life science companies need to be in accordance with GxP guidelines, ensure compliance with complex regulations and facilitate regulatory inspections.
A reliable standardized system, tailored to meet your organisation’s needs, can vastly improve the efficiency of your operations.
Reducing the total cost of ‘quality’ and reducing non-conformances within manufacturing are key challenges for quality assurance management. The everyday issues that need to be managed include:
- Human error and imperfect quality of raw materials – These can have a significant impact on the quality of your laboratory’s services and the profitability of your business. It is necessary to maximize efforts in order to mitigate the risk of shipping products that do not meet requirements.
- Excessive paperwork – Quality assurance personnel spend a substantial amount of time searching for and approving results.
- Traceability and defensibility – Efficient and fast access to correct and complete data is necessary during a regulatory audit.
We can help you to ensure your quality assurance operations meet these key success factors:
- Efficient product release – Easily manage the complete review and approval process to ensure correct sign-off. Delivery of results on an ongoing basis and elimination of redundant steps significantly speeds up the review process.
- Control of product quality – Trending batch results and performance of raw materials gives you better control of your processes and final product quality.
- Control of your data – All release data is centrally located and easily accessible on demand, so you can meet requirements from regulatory authorities.
- Complete audit-trail functions to ensure data accuracy.
Improving your quality assurance operations with the help of PlantVision can help you to achieve these important benefits:
- Higher and more consistent quality in production.
- Reduced workload for quality assurance personnel enables them to carry out additional tasks, as well as lowering costs.
- Compliance – fulfillment of ISO 17025, GLP, 21 CFR Part 11, GAMP and other regulatory requirements.
- Data integrity – original data is preserved and changes are traceable from registration through to delivery of final report.
We are pleased with the customized LIMS system and the support from PlantVision both during development project and drift phase. PlantVison has supported our project with skillful and engaged specialists.
PlantVision understand both our and our customers’ operations. We can rely on them to deliver smart and user-friendly solutions.
Before, we were forced to enter lab results at a specific time. Now, we enter results when it suits us. It is also easier to view results, and for relevant parties to examine and comment on them.
Thermo Fisher Scientific
Thermo Fisher Scientific is the world leader serving the global science community. The company’s integrated informatics solutions help customers to drive productivity, ensure compliance, streamline processes, and improve organizational efficiency.
Together with Thermo Fisher Scientific we offer a complete suite of integrated solutions, including Thermo Scientific™ SampleManager LIMS™, the world’s most widely deployed LIMS (laboratory information management system).
SampleManager LIMS supports both regulated and non-regulated industries, including pharmaceutical QA/QC, oil and gas, chemicals, water and environmental, food safety and contract labs. Enhanced functionality empowers timely decision making and helps you to increase productivity and improve the agility and responsiveness of your lab.
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