The objective of this white paper is to discuss the electronic record and Data Integrity compliance readiness of Waters® UNIFI® Scientific Information System for the regulated scientific laboratory.
Regulated pharmaceutical and biotechnology companies serving the US market are currently striving to meet compliance with 21 CFR Part 11, the U.S. Food and Drug Administration’s (FDA) rule governing electronic records and electronic signatures. Companies providing product for countries other than the USA, are also expected to meet the relevant electronic record and Data Integrity requirements from the governing Health Authorities of those countries with the Medicines and Healthcare products Regulatory Agency (MHRA) taking a lead in this area. Additionally the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/s) have issued guidances for managing electronic records and data.
Meeting Data Integrity expectations, including Part 11 compliance, remains challenging. However, eventually e-record regulations will be viewed as a significant driver to move companies from a paper-records environment to a more efficient and complete electronic-records environment. Although it is understood that merely purchasing an informatics platform that incorporates Part 11 or Annex 11 technical controls does not make a lab fully compliant or guarantee Data Integrity. Technical controls should be inherent in any system that is used in a regulated environment. A suite of technical controls for 21 CFR Part 11 and Annex 11 compliance are built into UNIFI to simplify administration and allow laboratories to meet global electronic record regulations.