Facility C&Q projects require coordination, collaboration and tight control in order to be successful. Despite challenging logistics involved in the actual building, procurement or equipment installation, the real challenges lie in documenting these activities in order to demonstrate compliance.

The different skill-sets and expertise of the people involved, reliance on unproductive manual systems or lack of real-time control over individual tasks result in unreasonably high C&Q costs and delays.

Product Collateral

• QAvalid Facility™

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QAvalid Facility™ is a Web based system designed to manage facility commissioning and qualification projects. Unlike paper or spreadsheet systems, QAvalid Facility™ allows engineering and commissioning professionals to control and track the status of each equipment or system from the initial requirements through vendor selection, risk assessment and qualification.

Users are able to connect and synchronize the equipment inventory with requirements, risk assessments or qualification documents. This ensures that the inventory is kept up-to-date and that the status of each equipment can be promptly justified by retrieving the attached documents.

Configurable electronic workflows supported by automatic audit trails and electronic signatures reduce the time needed to complete the project and ensure that FDA requirements are met. Integrated change control and configuration management also ensure that documents are kept compliant.

The QAvalid Add-In for Microsoft Office allows users to perform controlled document writing, reviewing, approving and testing within Microsoft Word. QAvalid Facility™ is efficient and simple to use because it captures all the necessary information within the actual documents and users are not required to reenter information.

QAvalid Facility™ 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 Facility™ Benefits:

• Ensures that regulatory requirements are met substantially faster than with current systems
• Provides unique content level linking between documents to reveal change impact
• Monitors compliance throughout the project (including project specific procedures)
• Ensures that regulatory requirements are met substantially faster than with current systems
• Documentation and change control activities easily managed with engineers and contractors
• Provides unique content level linking between documents to reveal change impact
• Integrated support for HAZOP Risk Assessment methodology
• System GxP impact assessment and qualification status included into Validation Master Plan (VMP)
• Integration is available for mainstream systems such as Microsoft Office, Microsoft Project and Primavera