Risk based Facility C&Q


The design, construction, commissioning and validation of pharmaceutical facilities are significant challenges for project managers, engineers and quality professionals. Whether it is a new or upgraded facility, commissioning, qualification and validation are the foundation for assuring success in further manufacturing process validation. Before you begin validating a manufacturing process as acceptable facility, utilities and equipment to support the manufacturing operations must be in place. Facility qualification (a part of validation that proves and documents that equipment or ancillary systems are properly installed, work correctly and actually lead to the expected results) and validation activities will establish and provide documentary evidence that the premises, supporting utilities, equipment and processes have been designed, installed and operate in accordance with the requirements of cGMP.

Involvement of different stakeholders within the organization and external vendors for construction with varying skill sets and expertise – with reliance on unproductive paper based manual validation – leads to delayed review, approval and inconsistency in documentation. Disconnected information in different phases of validation, lack of real-time control over individual tasks can result in unreasonably high commission and qualification costs and delays. Overall, there is no control on the process and budget.



ValGenesis VLMS is a web based validation lifecycle management system configured to manage facility commissioning and qualification projects. Unlike manual paper systems ValGenesis allows SMEs to enable Risk based commissioning and qualification process by identifying directly and indirectly impacted systems. ValGenesis VLMS system will help you to identify all the facility components, instruments, equipment, processes, etc. and define the deliverable requirements at the individual object level or combination of objects as per the approved SOPs and processes. The required deliverables will be managed through a Validation Framework and Projects available in ValGenesis VLMS. Vendors can access the system and upload/update the deliverables for SMEs approval if required. All types of deliverables will be managed 100% paperless with required regulatory compliance for security. For example, approved qualification protocols may be taken offline for execution in the field (on tablet PCs or laptops) so there is no network connection required to execute the test cases. The executed test cases will be synchronized back into the system where the work process continues. ValGenesis comes with out-of-the-box, easily customizable workflows which support handover, qualification and change activities.


Typical commissioning and qualification process detailed in the following diagram

Validation Lifecycle Management


Following are some of the features and benefits of ValGenesis VLMS for the facility commissioning and qualification process:

  • Develop and approve a project plan with well-defined quality gate checks for commissioning activities that defines the vendor and construction quality assurance tasks and the commissioning documentation deliverables.
  • Conduct design reviews with risk assessment to ensure all critical requirements have been factored into the design and perform an impact assessment of systems, equipment and major equipment components based on the risk level.
  • Develop a strategy for level of documentation requirements for each system or piece of equipment based on the risk level. Developed strategy or plan can be approved by all stakeholders to avoid or minimize deviations.
  • To maintain the consistency with C&Q deliverables generated by internal SMEs and external vendors, templates can be enforced with required sections. For example the protocols should have sections for design verification, installation verification, review of documentation of construction quality assurance activities, start-up checks, initial operation checks, full functional testing, loop tuning, cycle development, etc. System enforces users to complete these sections before routing it for review and/or approval.
  • GxP Asset Management with real-time validation status
  • ValGenesis VLMS provides validated connectors for enterprise systems including SAP, MS SharePoint, EMC Documentum, etc. to pull the asset information and other related data from these systems to expedite the commissioning and qualification process.
  • ValGenesis VLMS system is office-centric, providing add-ins for Microsoft Office allowing users to perform controlled document writing, reviewing, approving and executing the test cases within familiar MS Word and MS Excel applications. There is very little or no training required for your vendors to use the system.
  • Reduce commissioning and validation effort through workflow process automation
  • Expedite the re-configuration of a plant for the production of different drugs through electronically managed plant configuration management
  • Track and manage disposition of all deviations, using best practice electronic work processes
  • Greatly eases a plant manager’s ability to respond to spot inspections and audits, allowing them to view all the information available about a tag, item of plant, system or almost anything else – including the entire plant – at the current revision level at a given point in time.
  • 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 item of equipment can be promptly justified by retrieving the attached documents.
  • Continuous Monitoring of compliance throughout the project (including project specific procedures).
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