1. 21-CFR Part 11 Compliance
21-CFR Part 11 Compliance
? PART 11 COMPLIANCE SOFTWARE FEATURES
21-CFR
?Audit Trail (user, Equipment, Alarm SMS, Events).
Secured
? And E-signature with Date and Time Stamp.
E-records
? Kinetic Temperature).
MKT (Mean
? Equipments Connectivity.
Unlimited
? Analysis.
Real Time
? Analysis.
Graphical
? User Login Change Password.
First Time
? Encryption.
Password
Alpha Numeric Password and Password Ageing.
?
System Administration.
?
? Multilevel Username & Password.
Authorized
Master Data
Data Acquisition.
?
Offline Analysis (in Tabular and Graphical Analysis).
?
Chamber Add Facility Real Time Summary ? with Reason Master.
Open Door
Data Generated on PDF Format.
?
? Parameter Setting.
Realtime
?(RDBMS) Database
My SQL
? Back up Facility.
Automated
Auto Logout , Account Blocking and Reactivating Facility.
?
? Event and Audit Trail Data Recording.
Log Data,
Scanner Data
Input Output Status Real Time Display
Data Acquisition with Alarm System
Micro Biology Micro Biology
R & D Data R & D Chambers Data Incubators
MODEM
Server in IT Room
Alarm Server
In Utility Dept.
Door Open Reason Master
QC Data QC Stability Stores Data Stores Chambers
Chambers
For information log on: www.mackpharmatech.com Audit Data For information log on: www.mackpharmatech.com