Equipment and Instruments Validation

Achieve a controlled state of validation with automated tasks, managed scheduling, and a reusable content library that supports a family approach to equipment and instruments validation.

Benefits this Solution Provides

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Integrate OEM/Vendor Validation

Merge vendor data and test results, such as factory/site/user acceptance tests (FAT/SAT/UAT), directly into your protocol test steps with source references.

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Enforce Standards

Control and enforce standards with risk-based process conditions, predefined frameworks, standardized templates, and business rules.

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Improve Regulatory Compliance

Adhere to 21 CFR Part 11, EU Annex 11, and ALCOA++ principles.

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Cut Validation Time in Half

Dramatically reduce cycle time with electronic execution, push button screenshots, and embedded deviation/exception handling.

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Work More Efficiently and Collaboratively

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  • Leverage historical test scripts for content generation from risk-based decision trees. 
  • Fully automate the entire equipment and analytical instrument validation lifecycle from planning to execution in one easy-to-use system. 
  • Work and collaborate on validation initiatives worldwide, expediting quality assurance, production readiness, and preparation for regulatory audits and inspections.  
  • Allow authorized users, including third-party business partners, consultants, and contract manufacturing organizations, to check validation status in real time 24/7/365.

Streamline Protocol Execution

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  • Assign and schedule review, approval, and execution of protocol documents, enabling timesaving split execution whereby a single protocol can be divided among the team to expedite the validation task. 
  • Implement equipment and instruments families to create common libraries that increase the reusability of test scripts.
  • Capture objective evidence within the protocol with no printing or scanning required. 
  • Execute protocols offline with our mobile application.

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Improve Deviation and Change Management

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  • Manage execution failures easily with automated deviation workflows. 
  • Trace deviations back to requirements and maintain a complete audit trail. 
  • Enforce deviation review, approval, and re-execution workflow requirements to ensure the correct documents are routed to the appropriate individual or group. 
  • Enforce processes to accommodate any equipment changes or instrument updates. 
  • Generate a delta-validation protocol with minimal effort and ensure compliance to change control requirements. 

What Can You Expect From Implementing Our Solution?

Before After
Data is compartmentalized into disconnected silos, making it difficult to obtain the equipment and instruments lifecycle data you need for timely decision-making. Data is stored in a single system, giving you, your clients, and regulators instant access to all lifecycle deliverables and supporting data.
No change control; it is impossible to assess and track the impact of changes to system specifications and compliance requirements. Integrated change control; the system tracks the chronology of each change and produces a complete, compliant audit trail.
Inefficient, unstandardized workflows require you to assign review/approval status manually. Standardized, enforced workflows across sites are configurable and allow you to assign review/approval status electronically.
Valuable information is stuck in paper documents and records that are archived and often forgotten. Information is readily available. You can generate standard or ad hoc reports and even export reports to MS Word, Excel, or PDF at the push of a button for further analysis.

Learn More From Our Experts

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Blog Post

Equipment and Instruments Validation

Boost Efficiency with Digital Equipment Qualification and Validation

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Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

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A Roadmap to Digitalize Your Control Strategy

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