21 CFR Part 11 remediation strategies
by Eurotherm Inc.
This white paper by Eurotherm Inc. describes ways to achieve compliance with the requirements of 21 CFR Part 11, specifically regarding the use of electronic records as a primary source of data for the pharmaceutical industry, and the role of remediation. This white paper sets out four options for remediation: Replace the existing control system; add compliant computer data acquisition to the existing control system; add a compliant Eurotherm Chessell data logging unit to the existing control system, or add a compliant Eurotherm ‘front end’ to the existing control system.
| Published: | 2004 |
| Format: | |
| Length: | 7 pages |
| Type: | White paper |
| Language: | English |
.
SPONSORED REPORTS
