At Eurotherm we passionately support our customers with Life Science specialist knowledge and experience to help achieve process excellence through machine & process automation efficiency, regulatory compliance such as 21CFR Part11, Annex 11, DATA INTEGRITY ALCOA concept and Good Engineering Practice (GEP), implementing projects using the ISPE GAMP5 guidelines. All Life Science Government organizations and major Life Science Association Advisors have created Guidelines on Data Integrity.
Data integrity can apply to electronic and paper records, but regulators’ recent focus has primarily been on electronic records.
ALCOA guidelines have been around in draft form since 2016, and are included in the latest MHRA, FDA, PIC/S Data Integrity Guidance and Definitions released in 2018.
For over 50 years Eurotherm has supported our customers’ validation and regulatory compliance activities and can support a Data Integrity Assessment & Remediation initiative to not just address the creation of electronic production records but more broadly to address data governance throughout their plant operations.