Anmeda Efficacy Stability Chambers

Anmeda Efficacy Stability Chambers for Pharma plants, which provides 21 CFR Part 11 compliance integrated utility management system along with real-time centralized monitoring and control for the Stability Chambers, Incubators and Ovens by integrating all the machines and providing continuous data acquisition of alarms and other critical process parameters, notifications and user management with audit trails as per the 21 CFR Part 11 guidelines.

Anmeda Efficacy Stability Chambers, with plant-wide integration capabilities, can also provide other value-added features such as integration with production, monitoring equipment efficiency, Energy monitoring, maintenance tracking, and various analytical reports and dashboards.

Anmeda Efficacy Stability Chambers enhances the capabilities of the existing system by integrating all the individual equipment from different OEM's into a centralized common network and deploying a common software system which is capable of integrating all the equipment for monitoring and control with CFR compliant features that will enable each connected equipment to leverage the features of the common centralized software, hence making each equipment CFR compliant. Anmeda Efficacy Stability chambers provide common binding system for all the connected equipment.

Advantages

• > Achieve 21 CFR Part 11 compliance for the Stability Chambers, Incubators and Ovens.


• > Achieve operational excellence and effectiveness.


• > Flexibility to adapt, configure and extend capabilities as required.


• > Anmeda solution provides faster implementation to results.


• > Flexible and scalable application architecture enabling integration from single plant to multiple plants.


• > Provide Data Storage and expansion capability which is configurable based on requirements.


• > Anmeda Efficacy supports Open Standards for third-party application integration such as ERP, eBRM, BMS, Energy Management, and so on.

Features

• > Centralized data acquisition, historical data storage and complete data management.


• > Centralized monitoring and control with multiple user management.


• > Alarms & Events Management with alarm trend and analytics.


• > Real-time trends of critical parameters.


• > Auto Generation and emailing of mandatory reports as per configured schedule and as per configured email addresses. Notification via Email & SMS    can be configured individually.


• > Soft Approval System: Review & Approval in Web-based system by attaching the reports with electronic signatures based on user authentication. Each    action (such as Generation, Checking & Reviewing) carries a comment and time-stamp.


• > Scheduling of Reports based on the Line In-charges or operators with concerned person emails, based on Escalation matrix.


• > In case of concerned person not available to review the report, Administrator/Manager has option to manually forward the report to higher authority for    review to close the report work- flow.


• > Dashboards for Administrator/Manager to view the status of report approvals & take necessary actions.


• > Complete Audit Trail Reports covering all user activities such as login/logout, addition and deletion of users, report generation, review and approval    activity and so on.


• > Centralized User management with multi-user support and integration with corporate LDAP directory.


• > Machine performance tracking and analysis.