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 EMA, as well as global institutions and associations like the WHO, ISPE, PIC/S and local CDSCO, NMPA, MHRA, ANVISA, etc., emphasize the need for accurate measurement and secure storage of critical process and environmental parameters. If such 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 recalls, 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
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 chains. 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 validation 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 trusted advisor to the industry Watlow offers a range of solutions to help main data integrity throughout the data lifecycleLearn more
The Data Lifecycle
Discover the data lifecycle and dataflows within Watlow recorders and associated PC tools, from data creation, through data processing, reviewing, reporting and use to data retention retrieval and destruction.Learn more
Data Management, Acquisition and Control Solutions
The portfolio ranges from discrete products and software to engineered systems, embedded with a variety of features that help meet Data Integrity ALCOA+ principles.Learn more
Store and Forward Feature
Eurotherm Store and Forward feature aid's reliability of data archiving, supporting the ALCOA+ data integrity concept by providing original, attributable adata that is contemporaneous, consistent, and complete.