Manufacturing Compliance Management Solutions:

Our partner solutions which are designed for industrial automation are helping the regulated industries with the large benefits they offer. The solutions are 21 CFR Part 11 compliant and helps in Manufacturing Compliance Management

Sterile Area Access Control (SAAC)

The SAAC Solution controls the people entry/exit in the sterile areas as per GMP. The SAAC solution can be implemented using industry standard access control components. SAAC provides comprehensive and intuitive reports to aid in the prevention of contamination of sterile areas.

Key Solution Features:
1. Tracks number of people & entry-exit events using biometric readers.
2. Restricts number of people based on SOP, including capturing Purpose of Entry.
4. Duration of people inside sterile area is tracked; alerted as per SOP .
5. 21 CFR Part 11 compliant user management and audit trail.
6. Tight integration between biometric readers and door interlocking.
7. Integration with Email/Mobile Alerts.
8. Dashboards and Reports.

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Manufacturing compliance console (MCC)

As the name implies, the MCC solution is meant to drive compliance at a manufacturing station. MCC provides interfaces through which interventions can be recorded automatically. The MCC Solution is CFR 21 Part 11 compliant and can support server or standalone architecture.

Key Solution Features:
• Touchscreen for Intervention recording
• Creates batch-wise Intervention reports
• Tracks intervention count and duration
• PDF/Video reference to SOP
• Integration with Filling Machine/sensors
• Supports Stand alone/ Client-Server Architecture
• Data Analysis for Training and Process Improvement
• CFR 21 Part 11 Compliant

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Automated Solution Dispensing System (ASDS)

CFR 21 Part 11 compliant ASDS solution is meant for on demand solvent preparation supporting up to 6 different solvents apart from IPA and Water. ASDS is fabricated using pharma compliant stainless steel. It has automated record keeping, Historical data storage and audit trail. The ASDS has an easy to use HMI and has wheels on the base for easy movement.

Key Solution Features:
• Dispensing volume accuracy +/- 3%
• Effectiveness is guaranteed as the solution is prepared on demand
• No wastage of solvents/water
• 21 CFR Part 11 Compliant
• Easy to install and maintain

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