21-CFR Part 11 Compliance

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? Secured Audit Trail (user, Equipment, Alarm SMS, Events).

?E-records And E-signature with Date and Time Stamp.

?MKT (Mean Kinetic Temperature).

?Unlimited Equipments Connectivity.

?Real Time Analysis.

?Graphical Analysis.

?First Time User Login Change Password.

?Password Encryption.

?Alpha Numeric Password and Password Ageing.

?System Administration.

?Authorized Multilevel Username & Password.

?Data Acquisition.

?Offline Analysis (in Tabular and Graphical Analysis).

?Open Door with Reason Master.

?Data Generated on PDF Format.

?Realtime Parameter Setting.

?My SQL (RDBMS) Database

?Automated Back up Facility.

?Auto Logout , Account Blocking and Reactivating Facility.

?Log Data, Event and Audit Trail Data Recording.

21-CFR PART 11 COMPLIANCE SOFTWARE FEATURES

R & D Data R & D Chambers

QC Data QC Chambers

Stability

Micro BiologyData

Stores Data

Micro BiologyIncubators

Stores Chambers

Alarm ServerIn Utility Dept.

Server in IT RoomMODEM

Data Acquisition with Alarm System

Real Time Display

Door Open Reason Master

Input Output Status

Chamber Add Facility

For information log on: www.mackpharmatech.com For information log on: www.mackpharmatech.comAudit Data

Master Data

21-CFR Part 11 Compliance

Scanner Data

Real Time Summary