Top 10 questions about 21 CFR Part 11 compliance
by Siemens Corp.
This white paper by Siemens Building Technologies Inc. provides insight on 10 questions pharmaceutical engineers have regarding 21 CFR Part 11 compliance, which are grouped into three main categories: interpreting the rules, building automation system applications and technical and procedural implementation. Subjects include protecting electronic records and implementing electronic signatures, building automation and the protection of electronic records.
Other subjects include whether to replace existing building automation systems, merging or transfering old data into a new system, and strategies to ensure that a building automation system is fully compliant. The answers provides useful strategies in assessing the total impact of 21 CFR Part 11 and successfully implementing changes that are both compliant and cost-efficient.
| Published: | 2005 |
| Format: | |
| Length: | 5 pages |
| Type: | White paper |
| Language: | English |
