Accurate production and regulatory compliance made easy
Adherence to strict healthcare regulations, Quality Control (QC) and Statistical Process Control (SPC) measures, and keeping Electronic Batch Records (EBR) throughout the manufacturing process, as achieving efficient processes, maintaining quality and meeting compliance requirements is a challenge.
The solution to improve the efficiency of your production is a Manufacturing Execution System. It provides the platform for manufacturing execution, data collection, data analysis, reporting, information distribution and resource management.
The availability of accurate, timely, and actionable enterprise-wide information is critical to improve your overall manufacturing performance. Our Manufacturing Execution System is at the heart of your production, allowing you to gain visibility and take relevant actions.
Improve your data consistency and quality in real time.
Keep accurate real-time Electronic Batch Records.
Access your complete compliance documentation whensoever.
21 CFR Part 11
Leverage the 21 CFR Part 11 standards compliance to ensure regulations adherence.
Quality and Compliance
Manage all essential elements of quality such as SOPs, tasks, accountability, traceability, notifications, audit trail, reports, scheduling, and analysis.
- Manage workflows, business rules, SOPs, tasks, and analytics
- Record your process-related, data, defects, waste, yield, and observations
- Provide electronic records and reports for in-depth analysis
- Involve your stakeholders in corrective actions to ensure continuous improvement
- Analyze production hazards and critical process control points historically and in real-time
- Manage regulatory requirements related to traceability, audit trail, and digital signatures
Production Management and Performance
Benchmark performance and productivity, by collecting and aggregating data, to deliver real-time, actionable intelligence for significant productivity improvement – while leveraging your existing assets, resources and infrastructure.
- View your production summaries (actual v. target) enterprise wide
- Enclosure and all exposed components are NEMA 4 (IP64/65) rated
- Compare improvement activities and their result
- Improve your production planning, scheduling, productivity, and profitability
- Evaluate root causes of poor performance
Automate your recordkeeping process and store all necessary documents in a centralized, web-based location so every stakeholder involved in your process can find the most up-to-date documents in one place.
- Automate Collection of your process data from raw materials to finished product
- Combine data collection with your operator observations, workflow checks, and feedback
- Real-time notifications of non-conformance events
- Accurate production information to meet your regulatory reporting requirements
- Compliance and traceability throughout production processes built in by design
- Compliance with the FDA’s 21 CFR Part 11 and European Annex 11 regulations
Define, plan, manage, execute, and optimize all maintenance activities throughout your manufacturing operations. Gain actionable insight through comprehensive electronic records of all tasks, assignments, results, and KPIs along with your customized reports and dashboards.
- Real-time visibility into your maintenance schedules and activities
- Convenient 24/7 access to maintenance instructions, SOPs, and service contracts
- Simple user interfaces for scheduling and executing maintenance
- Decrease your maintenance costs: problems can be resolved before they result in downtime or stoppages
- Augment existing maintenance software functionality where operational gaps exist
- Improve the overall efficiency and cost of your maintenance program
Detect and report on your products in real-time with actionable data, proving to partners, regulators, and customers that your products are made in compliance with correct processes.
- Avoid product recalls and poor quality resulting in brand loss
- Comply with all regulations and governing bodies
- Reduce your business risk for; regulatory requirements, increased recall effectiveness and speed, and brand consistency
- Manage logistics in real-time accurately and effectively
- Decrease your scrap and waste from poor quality and non-conformances
- Get a comprehensive view of your operations, including:
- Material Receiving
- Material Location Tracking
- Finished Goods Lot Identification
- Material Consumption and Finished Goods
- Product Shipping
By defining workflows and tasks, automate assignments and gain visibility into your process improvement opportunities. The real-time workflow management and task capabilities drive product quality and business profitability, dramatically impacting productivity.
- Reduce wait time
- Communicate tasks
- Automate information
- Lower your production costs
- Decrease waste and rework
- Improve customer satisfaction
Take advantage of a versatile recipe and batch management capabilities designed for executing your batching operations. The integrated functionality makes it possible to enforce SOPs and tasks, recipes, versions, assets, materials, and labor. A complete electronic audit trail of your transactions can be available to meet the most stringent EBR requirements. As a solution for manual and automatic operations, you can:
- Defines necessary materials needed and coordinate with ERP
- Enforces compliance with all regulatory requirements
- Traces your materials to their lots and suppliers
- Handles weight instructions for specific materials
- Maintains your electronic records for all transactions
- Tracks and traces material usage and consumption throughout the value stream
Materials & Inventory
A real-time application in manufacturing operations management can connect directly to production, determining your process capabilities based on materials and constraints. Through advanced analytics and benchmarking, it readily determines ideal inventory levels based on process capabilities, quality, consumption patterns, yield, suppliers, production constraints, and asset performance.
- Manage your material consumption based on jobs in various areas and stages of production
- Source lots, quantities, transaction time and date, locations, operator ID, utilized assets, related tasks, and more
- Record e-signatures for complete track and trace functionality
- Optimize your inventory levels using material consumption and lead time statistics
- Balance between fulfilling your orders and over stocking
- Rank your suppliers by performance to utilize the best and most cost-effective
At your side to optimize your manufacturing operations and energy efficiency
We believe in appreciation of individuals, team collaboration and empowerment as part of our culture. We drive projects in close partnership with our clients to enable idea generation, motivation and commitment. Our role is also to facilitate for change by caring for people’s needs and emotions.
Discover how we understand your needs, focus on what is most valuable for you and deliver customized solutions.