Life Sciences Functional Benefits
QAD life sciences edition supports critical quality requirements including corrective action/preventive action (CAPA) and adverse reaction reporting, and provides a full range of validation capabilities. QAD provides a suite of tools to assist in Current Good Manufacturing Practices (cGMP) validation, including advanced controls, audit trails and the use of eSignatures.
QAD Enterprise Applications solution addresses most aspects of a life sciences company’s business processes, including:
The process map below demonstrates the breadth of QAD’s life sciences offering.
QAD Manufacturing in Life Sciences
Reduce costs and increase throughput using QAD Enterprise Applications to plan, schedule and track products:
Master and Production Scheduling Workbenches: Provides simple, visual manipulation of the master schedule and planned production. Planners can schedule production to meet demand more effectively and take action when problems are imminent.
Manufacturing Planning: Includes fully integrated MPS and MRP and supports all production control methods such as repetitive, discrete and mixed-mode environments. Allows for simple adoption of tactical plans to meet and exceed customer expectations and changing demands.
Repetitive Manufacturing: Provides high-volume, repetitive scheduling across multiple production lines, even sharing the same resources used by discrete items controlled with work orders, including full support of serialization.
Lean Manufacturing: Supports companies adopting lean principles; QAD’s integrated Lean Manufacturing supports Kanban, TAKT time calculations and visual control methods. This makes lean adoption finally feasible for regulated manufacturers in the life sciences market.
Configured Products: The QAD Product Configuration suite allows for configuration of products at order entry or quotation, and creates bill of materials and routings for manufacturing. By linking the shop order and the sales order, the configurator reduces shipping errors and enhances customer satisfaction.
Computer System Validation: Provides detailed processes, scripts and supportive activities to enable companies to meet regulatory audits against Current Good Manufacturing Practices (cGMP). QAD Life Sciences Edition On Demand is an FDA qualified environment, significantly shortening the effort and time for customers to achieve certification.
Serialization: Supports regulatory compliance for aggregated product serialization on pallet, shipper, case and unit levels. QAD Serialization offers serial number management, packing/unpacking and full-serialized inventory management.
Quality Management: Supports product quality, including inspection and testing, incoming inspection of purchased items and inventory sampling. This includes definitions of standard testing procedures and manages inventory sampling plans and quality work orders, CAPA and adverse reaction reporting.
Capital Projects: Supports the financial aspects of project management, including reporting throughout the process and capitalization on completions.
Full Lot Traceability: Provides history from finished goods back to the supplier’s lot. Adds extensive lot/serial trace and reporting functions to work-in-process (WIP) and generates tracing information at the operation level whenever the company uses registered resources.
Outsourcing/Subcontracting: Tracks financial obligations and the flow of materials, allowing seamless control of outsourced production as though it were a part of one production schedule.
Compliance Management: Provides critical manufacturing controls at the batch level, including the ability to track additional item and work order attributes and key batch dates. This solution also provides the ability to manage controlled substances, track DEA and other regulatory agency licenses, support controls required by Current Good Manufacturing Practices (cGMP) and provide for the use of eSignatures.
Data Capture: Provides integration to various data capture technologies, including RFID and bar coding for real-time transaction capture and validation of scanned data, eliminating manual data entry.
Enterprise Asset Management: Supports all plant maintenance activities, including preventive maintenance and predictive management, work orders and service requests to ensure equipment is reliable and ready to go at all times, and compliance with regulatory mandates regarding product safety and cleanliness standards.
Master Data Management: Provides capabilities for tracking part numbers, bill of materials (BOM), routings and work centers, and integrates to Product Change Control (PCC) or Product Lifecycle Management (PLM).
Product Change Control: Provides control and improves information audit throughout QAD Enterprise Applications.
Attribute & Characteristic Management with Multiple Units of Measure: Assists in tracking additional item information at various levels of detail, such as lot, pallet, case, sub-case and volume. Also includes functionality to track product using multiple units of measure.