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Automation Compliant with 21 CFR Part 11 for Integrity and Trust

At Absolute Motion, we understand that pharmaceutical automation demands more than precision — it requires uncompromising data integrity, security, and regulatory compliance. The FDA’s 21 CFR Part 11 regulation is a cornerstone for electronic records and electronic signatures in pharmaceutical manufacturing, ensuring traceability, authenticity, and control over critical digital data. Our automation solutions are designed to fully comply with 21 CFR Part 11, enabling you to replace paper-based processes with secure, validated electronic systems that uphold your operational and regulatory commitments seamlessly.

Key 21 CFR Part 11 Compliance Features in Our Solutions

System Validation

Rigorous validation protocols ensure that all hardware and software components perform reliably and consistently, preserving data accuracy throughout the entire lifecycle.

Secure User Access Control

Role-based permissions restrict system access to authorized personnel only, preventing unauthorized data manipulation and ensuring accountability.

Audit Trails

Computer-generated, time-stamped audit trails document all electronic record changes, detailing who made the change, when, and why — enabling full transparency for regulatory audits.

Electronic Signatures

Our systems support FDA-compliant electronic signatures that uniquely identify and authenticate users, replacing traditional handwritten approvals without compromising security.

Data Integrity & Retention

All electronic records are securely created, stored, and archived with robust measures against loss, corruption, or tampering.

Comprehensive Training & Documentation

We provide thorough operational training and documentation to ensure your team meets compliance requirements and maintains ongoing system integrity.

Why Choose Absolute Motion for Pharmaceutical Automation?

From manual batch records to fully digital production lines, Absolute Motion integrates intelligent automation that supports your compliance with FDA and global regulatory standards. Our solutions streamline operations, reduce errors, and maintain the highest quality and safety benchmarks required in pharmaceutical manufacturing.

We partner with leading pharma OEMs and manufacturers to build systems that not only optimize performance but also safeguard the trust and integrity upon which your reputation depends.