Beyond Regulatory Mandates

Life Sciences industry is undergoing a significant change. Some of the top trends include regulatory requirements from the quality perspective and the growing need to reduce costs by improving manufacturing processes and most importantly faster time to market new drugs and devices while meeting the regulatory mandates. These trends impact the entire value chain – Drug discovery to Sales and Marketing.
Safety, Quality and Compliance
Aid in adherence to environmental, operational, food safety and regulatory standards using innovative applications with a multitude of benefits:
  • Increase efficiency by capturing and monitoring critical quality information on the shop floor in real-time
  • Integration with automation systems provides quality control and Statistical Process Control (SPC), enabling rapid corrective actions
  • Ensure compliance with 100% inspection and validation of printed labels against the intended SKU
  • Ensures the right product is in the right packaging
 
Picture of Beyond Regulatory Mandates
Specification Management
Based on the current work order, MES Quality Edition will automatically look for the type of product, type of manufacturing operation & equipment to be used. In response, all Sample Plans for the Products, Equipment, and Operations are auto-generated and maintained according to Quality Specifications. 
Picture of Beyond Regulatory Mandates
Enforce Actionable Procedures
Digitise and automate manual / semi-structured processes that include people, equipment, and systems, with industrial workflow/task management solution to drive consistency and ‘best practices’ across the value chain. 
Picture of Beyond Regulatory Mandates
Label Validation
Inspect and validate printed labels against their intended SKU to help drug manufacturers to ensure the right product is in the right packaging.  Negate the impact on the undeclared allergen, not fit for purpose, regulatory non-compliance, brand damage etc. 
Picture of Beyond Regulatory Mandates
Visibility, Traceability, Quality and Compliance with Serialisation
Comply with GS1 standards for serialisation process covering Site, Line and Palletisation modules to
  • Track and Trace from manufacturing through supply chain
  • Access Integrated analytics from production to the end user
  • Get real-time supply chain visibility, enabling more accurate planning and scheduling decisions
 
Picture of Beyond Regulatory Mandates
Specifications
Type
Scenario
Industries
Life Sciences
Top