GE Fanuc Life Sciences: 21 CFR Part 11 Compliance Solutions

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With private and public healthcare organizations under ever increasing regulatory and market pressure, medical and pharmaceutical industries face incredible challenges to increase flexibility while at the same time dramatically reducing costs. At GE Fanuc Life Sciences, we have automation software and solutions to address unique requirements such as compliance documentation and validation. We work with our customers so they can grow their business while eliminating errors in production.

GE Fanuc Life Sciences and Pharmaceutical

Industry Applications

Batch Execution & Operator Work Flow

Quick to deploy solutions to automate your batch production environment making it more efficient and easier to operate with 100% consistency and meeting all regulatory compliance including 21 CFR Part 11.

Change Management Solutions

Detailed oriented and cost effective application tools so you can better manage your factory’s control system’s software and keep electronic records to meet 21 CFR Part 11 and other regulations.

Enterprise Data Repository with Real Time Visualization

A proven solution for regulatory environments allowing central storage and archiving of process data with the capability to visualize and analyze the data in real time.

GmP Compliance

Manage all of your compliance requirements while substantially reducing your operating costs with our suite of automation applications and our team of experienced Six Sigma certified managers and engineers.

Innovative Automation Technology

A wide selection of automation platforms specifically designed for regulated industries in order to reduce risk of production error, lower life-cycle costs and speed up process to market.

Plant Floor Data Collection & Analysis

A complete suite of quality and statistical process control software and solutions along with Six Sigma and compliance features to help you address all your plant floor quality needs.

Plant Performance Analysis & Execution

Make sense out of your manufacturing data with our powerful plant intelligence application modules to efficiently manage, secure and update your operation.

Visualization & Control, Trending & Alarming

Comprehensive solutions for monitoring, control and distribution of plant wide data, quickly and securely, incorporating electronic record keeping and signatures as specified by the FDA.