Equipment, systems and instruments that are critical and may impact product quality or patient safety need to be controlled and evidence of such actions provided.

Maintaining the inventory up-to-date, promptly identifying the specifications, risk assessments and qualification documents for each piece, or implementing changes consistently are some of the problems associated with the current systems.

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• QAvalid Equipment Inventory™

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QAvalid Equipment Inventory™ is a Web based system designed to manage the configuration of equipments, systems and instruments as electronic records.

By replacing manual methods, the system allows companies to improve the reliability of their quality information, increasing the level of compliance while reducing the time spent daily to ensure that GxP or ISO requirements are met.

Based on unique linking technology QAvalid Equipment Inventory™ allows users to connect the inventory list with requirements, risk assessments or qualification documents. This ensures that the inventory is maintained up-to-date and that the compliance status of each equipment can be promptly justified.

Thanks to this unique approach, users can rapidly generate an up-to-date validation status for equipments and systems and include it within the Validation Master Plan in order to meet the recently added GxP requirements.

Users can maintain a centralized inventory of all equipments, systems or instruments and can access it from any location through a simple Web interface. Furthermore, controlled editing and referencing of the inventory records can be performed offline in a familiar manner within Microsoft® Word.

To ensure compliance is maintained, modifications are implemented through a change control workflow supported by automatic audit trails. Linking to the change requests, all configuration baselines are stored in QAvalid and accurately present the item’s history: what changed, why and who approved it.

Re-calibration and re-qualification schedules built within the system allow users to demonstrate a planned, structured approach and also ensure that tasks are not overlooked.

QAvalid Equipment Inventory™ is part of the QAvalid suite designed to manage and automate quality and compliance processes. QAvalid integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

QAvalid Equipment Inventory™ Benefits:

• The equipment inventory and qualification, impact assessments, specifications, SOPs, etc are connected. The inventory information can thus be more reliable and documents are easier to retrieve
• Traceability across all documents reveals the change impact and highlights out of date documents, ensuring that a compliant stage is maintained
• Changes are routed through change control workflows, while all configuration baselines are saved and linked to the change requests
• The system supports re-qualification and re-calibration schedules, sending tasks whenever an activity is scheduled
• Export the inventory list from QAvalid to Microsoft Excel
• Controlled editing of inventory records in Microsoft® Word