Data Management designed to simplify regulatory compliance and enhance trust
Rapid world growth, globalization, advanced technologies for Pharma 4.0 automation and data analysis trends, are emphasizing the need for high standards of data quality and integrity. Good data practices (GxP) will enrich the quality of data, enabling life science companies to make strategic decisions on batch release, based on trustable data and analytical insights.
The pharmaceutical and biotechnology industries closely regulate data production and storage to make sure that data cannot be modified without detection. Regulatory bodies such as the FDA and EM, as well as global institutions and associations like the WHO, ISPE, PIC/S and the local CDSCO, NMPA, MHRA, ANVISA, etc. emphasize the need for accurate measurement and secure storage of critical process and environmental parameters. If suc storage mediums are electronic, then the methods used for controlling and monitoring of data should comply with regulations, for example FDA 21 CFR Part 11, to help ensure data integrity.
Lack of data integrity could lead to:
- Inadequate strategic data insights
- Audit warning letter
- Product scrutiny/suspension
- Important bans, forced recall, plant shut down/ debarment
- Legal action
- Loss of reputation/public trust
Our knowledge and expertise covers the following and more:
- FDA 21 CFR Part 11
- EudraLex Annex 11
- Data Integrity ALCOA+
- ISPE GAMP®5
- cGMP
Eurotherm solutions for the life sciences industry
With specialist knowledge and experience in the life sciences industry, Eurotherm delivers solutions that help businesses to reduce the time and cost of regulatory compliance, throughout their manufacturing processes and supply chain. Our solutions and services help customers to efficiently manage the quality, the safety, and the authenticity of manufactured goods, through machine and process automation efficiency, high integrity data management , and an ISPE GAMP® 5 engineering approach with qualification and valitadion services.
Data Integrity ALCOA + Concept
Enhanced regulatory requirements demand that GxP critical records comply with the ALCOA+ concept to maintain data integrity and quality. As a trusted advisor to the industry Eurotherm offers a range of solutions to help maintain data integrity throughout the data lifecycle.
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