Issue
- Certificate for FDA regulations in the manufacturing of pharmaceuticals, 21 CFR Part 11 "Electronic Records / Electronic Signatures."
- Can Building Operation incorporate a comment section to capture a reason for change made by an operator/user?
Product Line
EcoStruxure Building Operation
Environment
EcoStruxure Building Operation
Cause
Building Operation site in need of the compliance certificate for 21 CFR Part 11 "Electronic Records / Electronic Signatures." Usually, these are pharmaceutical manufacturing sites, and the full FDA document PRT11Elect.pdf is attached to this article.
Resolution
EcoStruxure Building Operation 3.2 and higher
Compliance Pack enables 21 CFR Part 11 compliance for regulated industries. The Compliance Pack is an add-on module to EcoStruxure Building to help regulated industries meet the compliance requirements for Electronic Signatures & Electronic Records that are in place in the region.
This feature in our EcoStruxure Building Operation software provides facility-wide accountability and traceability of the environmental conditions that can impact the quality and safety of products developed in controlled environments in line with the 21CFR Part 11 regulation.
Compliance Pack is a licensed feature and compatible with EcoStruxure Building Operation V3.2.1 and later.
|
Part Number |
Description |
|
SXWSWCMPLPK001 |
Compliance Pack – includes TimescaleDB, Digital PDF Signing, Change Control, For one Enterprise Server or one Enterprise Central |
For technical documentation and sales enablement tools for the Compliance Pack, please visit The Exchange Building & Power Extranet and use the search keyword: 21cfr ebo
EcoStruxure Building Operation 3.1 and below
EcoStruxure Building Operation V3.1 and below has not addressed the pharmaceutical market and there is no electronic signature feature set that meets the FDA regulations 21 CFR part 11.
For sales issues surrounding FDA regulations, please contact through your sales channel to the local Category Manager.
| Americas: | Americas.EcoStruxureBuilding@schneider-electric.com |
| EMEA: | EMEA.EcoStruxureBuilding@schneider-electric.com |
| Asia Pacific: | AsiaPac.EcoStruxureBuilding@schneider-electric.com |
