The ever-changing legal regulations for pharmaceutical companies drive the need for new, flexible tools that help to guarantee patient safety while securing efficient production processes and profitability. Sii Poland experts support clients in the areas of pharmacovigilance (PV) and process validation to ensure full compliance with the relevant standards. Find out more about Sii’s implementations delivered for the healthcare sector.
As regulatory demands continue to grow, organizations must be prepared to adjust their R&D, product manufacturing, quality management, and documentation to the current law. For instance, It is essential that medical product information contains all relevant details and is regularly updated. However, the question remains, how this information is collected and who ensures that it is revised. The answer is pharmacovigilance (PV), which involves experts overseeing patient safety, as well as collecting information on the benefits and risks of treatment.
Based on scientific and domain expertise in PV processes, Sii Poland experts deliver validated systems for the pharmaceutical industry to ensure effective risk identification and mitigation. Apart from ensuring full compliance with the appropriate international regulations, the cooperation aims at cost-optimization, a faster product approval process, and a shorter time-to-market. Sii’s projects in the pharmacovigilance area include systems aimed at adverse event management, signal tracking, analytics, and visualization.
More details about Sii’s realizations for the pharmaceutical industry and our end-to-end approach to project delivery are available in the study below. The material answers the following questions:
- How does pharmacovigilance impact the medical manufacturing process?
- What are the major business-related benefits of process validation in pharmaceutical production?
- What solutions does Sii offer for the healthcare sector in the PV area (e.g. literature review, data aggregation and consolidation, signal tracking)?
- What are the advantages of implementing a validated testing process based on risk assessment?