Ensuring compliance with 21 CFR Part 11 is essential in the modern pharmaceutical and biotech industries, where maintaining the integrity of digital records is paramount. Kevision offers comprehensive machine upgrade solutions to help organizations transition from conventional systems to advanced, automated solutions that meet regulatory requirements with ease.
We provide expert consulting in platform upgrades, automation retrofitting, and process optimization. Our team specializes in delivering customized solutions for each client’s unique regulatory and operational needs.
Our advanced automation and validation services enable a smooth and reliable transition to digital systems. These systems ensure accuracy, completeness, and consistency in data generation, maintenance, and transfer, building a secure framework for electronic records.
All solutions are 21 CFR Part 11 compliant, backed by thorough documentation and implementation support. This ensures our clients meet all regulatory standards for data authenticity and traceability.
Our services include comprehensive GAP and RISK analysis, as well as specialized 21 CFR Part 11 compliance consulting. This independent analysis helps clients identify and mitigate potential risks in their current systems.
We offer retrofit solutions for tablet presses, fluid bed dryers (FBD), rapid mixer granulators (RMG), coaters, blenders, tray dryers, and blister pack machines. Additionally, our automation expertise extends to centrifuges, autoclaves, DHS, SIP, CIP, water system generation, purification & distribution and distillation columns.
Our engineering team brings expertise across major platforms like Rockwell, Siemens, Mitsubishi, Omron, Beijer, Zenon, and NI-LabView, creating custom solutions for varied automation needs.
Kevision provides a global delivery model with highly skilled resources and thorough project management, ensuring efficient, timely, and cost-effective project execution
At Kevision, we understand the importance of efficient and accurate pallet aggregation in the packaging and shipping process. Our Manual Pallet Aggregation System offers a comprehensive solution to meet your aggregation needs, providing improved traceability, compliance, and operational efficiency.
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