Traditional paper-based Computer System Validation (CSV) is an inefficient and time-consuming process, plagued with significant obstacles that hinder progress. Such outdated CSV methods require highly skilled technical personnel to dedicate as much as 50% of their time to non-value-added activities such as tracking status, creating/printing paper-based matrices, executing protocols with pen/paper, scanning documents into file folders, archiving in a secured vault, etc. This means dedicating a large amount of time and effort to create/maintain validation deliverables over the span of the system lifecycle, which in turn creates compliance risks over time and the entire process becomes inefficient.

Unique features of ValGenesis VLMS for efficient CSV process

  • Decision tree-based system assessment to define system characteristics, such as GAMP 5 Categories, risk level, compliance requirements, etc.
  • Deliverable requirements to consider the system as validated or verified are also addressed, as per the approved Master Validation Plan (MVP) and validation procedures
  • Risk-based lean validation process means risk assessment can be conducted at the requirement and/or system level
  • Fully integrated closed-loop CSV lifecycle management process with validation and change control
  • Requirement level change management with dynamic impact assessment of associated requirements and test cases, achieved by generating a consolidated single executable Validation Summary to reduce change management effort by as much as 80%
  • Dynamic electronic traceability matrix generation, whereby the trace between the requirements and qualification test steps is quickly done
  • Any type of trail can be created including one to many, many to one, V Model, etc.
  • Electronic, manual, and robotic protocol execution
  • Alerts and reminders for periodic review and approvals are automatically sent via email
  • Leverage the power of test automation tools for robotic implementation of test cases to reduce execution time by as much as 90%

Computer System Validation

With the ValGenesis VLMS maintaining your organization’s CSV, your enterprise will experience several significant benefits:

  • Approximately 50% reduction in validation cycle time and cost
  • Consistent and standardized CSV process across the organization
  • Elimination of non-value-added activities such as manual tracking, paper-based execution, printing, scanning, etc
  • Significantly reduces effort required to create traceability matrices, from weeks to mere minutes
  • Increased compliance and reduced data integrity concerns
  • Tracked approvals with complete audit trails
  • Removal of data integrity issues with overall CSV process, particularly in the test case execution process

Resources

Videos

Efficient, paperless CSV
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Press Releases

Leading Global R&D-Based Pharmaceutical Company Chooses ValGenesis’s VLMS to Manage Validation Process
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Blogs

Challenges with Requirements Management during the Computer Systems Validation Lifecycle
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