Pharmaceutical and Biotechnology Industry Challenges
Biopharmaceutical companies are under great pressure in the need to enter the market while ensuring patient safety. The gap between the first biopharmaceutical company and the second market-leading company is growing, so that the production cycle of the product will be shortened in order to advance to the market. There is an intensification of global competition and the expansion of supply chains, as well as the requirements of laws and regulations of various regulators. For biopharmaceutical companies, there is no more important than the transparency and traceability of the products used to protect the safety of the patient. In order to maintain the competitiveness of biopharmaceutical companies, the challenge for each pharmaceutical manufacturer will be:
- Cut costs;
- Improve product quality;
- Meet the requirements of laws and regulations;
- Enhance the safety of products to protect the safety of patients;
- Shorten the time for the product to reach market;
Historically, compliance with laws and regulations relates to submitted and recorded information, but very few of them can be used to help improve the product. Access to information from fragmented, fragmented data in a knowledge-based manner will accelerate product innovation. Biopharmaceutical companies must adhere to the principles of quality risk management so that they can not only comply with laws, regulations and standards such as FDA, EMA and ICH, but also enable companies to maintain a competitive advantage.
Sharrix Solution
- Consistent risk management process standards to ensure that risks can be identified, analyzed and mitigated and monitored in an industry best practice.
- Audit tracking to ensure that companies comply with laws, regulations and industry standards such as FDA 510 (k), EMA, QS / GMP, FDA 21 CFR Part 820, FDA 21 CFR Part 11, ISO 14971 and ISO 13485;
- Comprehensive risk analysis method
- Proactively manage quality risks and prevent duplication of problems
- Risk management data into key decision criteria
