Challenges:
Inefficient and difficult to maintain:
Paper-based and hybrid systems for Engineering Change Notice and Preventive Action are inexpensive initially. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing ECN tasks and other documentation, obtaining approval and signatures, and manual search and retrieval of documents during inspections and audits.
No Integration and information Sharing :
ECN maybe triggered by customer or internally due to process change, cost down, market requirements, customer requirements, regulatory requirements, etc. With manual and hybrid systems, these sources are not connected, making data collection slow and incomplete. Without connectivity, critical information may fall through the cracks, and the ECN assessment is likely to be unreliable.
Solutions:
Blue Ocean ECN Systems are designed by industry practitioners and experienced quality consultant for automating the ENC process in any organization.
An automated ECN system reduces audit time and findings, and decreases risk of product recalls. It improves product quality and increase productivity, increases customer satisfaction, and ensures FDA and ISO compliance.
Blue Ocean ECN software is a robust, easy-to-use system designed to effectively manage change process integrate it with other quality processes critical to regulatory compliance, such as risk management and document management system.
Key benefits and features:
Blue Ocean Data Solutions is a highly experienced company provides turnkey manufacturing solutions. With more than 10 years of experience serving a large customer base in manufacturing and hands-on expertise in programming, software and statistical data analysis combine with six sigma and lean manufacturing methodology, we assist our clients to solve complicated operation problems – yielding profitability increases and driving service and product delivery excellence.
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