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Product overview

Ensuring continual validation

TraceLink’s Automated Validation Manager (AVM) is an automated validation service for end-users in highly regulated supply chains or those companies seeking to meet stringent GxP compliance standards. AVM provides a set of test cases for execution and a set of corresponding validation documents generated to support quality and validation requirements related to TraceLink application and platform releases.

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Automated Validation Manager offers:

A full suite of automated, continual tests

A flexible subscription model

Ongoing platform & solution enhancements

Industry challenges

Addressing the need for new methodology

As regulatory demands evolve and changes occur, life sciences companies must be able to quickly adapt to remain compliant. Current challenges include:

Preventing product flow disruption

Companies must be able to quickly adapt their track and trace solutions in order to maintain continuous compliance and prevent disruption to product flow.

Preventing product flow disruption
Adapting technology to industry changes

Technology solutions must evolve to keep pace with these industry changes, and life sciences companies need to validate software updates to mitigate operational risk by confirming that all new software functionality is working as intended.

Adapting technology to industry changes
Managing & validating software updates

With the unpredictability associated with compliance, companies face the challenge of managing and validating software updates more frequently—often resulting in the need for specific staff expertise and repeated labor-intensive testing.

Managing & validating software updates
Keeping resourcing costs low

Those who outsource validation because they do not have in-house expertise face high costs for consultants to manage the entire validation process for them.

Keeping resourcing costs low

Benefits

How Automated Validation manager drives efficiency

Meet internal & GMP validation requirements

Reduce internal time & cost

Eliminate manual processes

Leverage the TraceLink platform

Automate functional testing

Redirect scarce validation resources

Minimize risk & predict future cost

Internal

Benefits

Meet internal & GMP validation requirements

Meet internal and GMP validation requirements while keeping pace with industry compliance change and emerging business needs, including:

  • Evolving regulations
  • New and changing data and technology standards
  • Diversifying supply and trade partner requirements
cost

Benefits

Reduce internal time & cost

Enable your company to benefit from ongoing platform and solution enhancements, and facilitate ongoing operational and supply chain modifications, while reducing the time and cost to validate initial solution deployment and future modifications.

For Internal 39

Benefits

Eliminate manual processes

Eliminate the need to manually write and execute validation scripts against new functionality.

standardized

Benefits

Leverage the TraceLink platform

Leverage the TraceLink platform and network tenancy to benefit from the full suite of automated tests continually executed against platform and application releases.

For Internal 40

Benefits

Automate functional testing

Automate functional testing of TraceLink’s user interface and file transactions across standard TraceLink maps.

For_Internal_59

Benefits

Redirect scarce validation resources

Redirect scarce validation resources to internal needs while maintaining a thoroughly validated TraceLink infrastructure.

SPI

Benefits

Minimize risk & predict future cost

Minimize risk of non-compliance expanding, simplifying, and automating validation processes, and control and confidently predict future validation costs through a subscription model.

Capabilities

A fully executed, paperless package designed for compliance

AVM minimizes both the in-house and outsourcing burdens of validation by automating certain tests and confirming that current TraceLink software and platform capabilities perform as intended.

Planning & configuration

Enhanced documentation

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  • Define the scope of validation and govern the execution of the validation process with a validation plan.
  • Set user requirements specifications, which include requirement description, type, priority, status, and risk requirements metrics based on functionality, priority, and risk.
  • Functional risk assessments outline the risk associated with the functionality based on its business impact coupled with a risk assessment that is performed with each release to determine potential business impact.
  • Access detailed test cases for specific applications and use cases, and the results of automated and manual testing.
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  • Obtain testing certificates, including Installation Qualification (IQ) and Operational Qualification (OQ) certificates.
  • View all requirements, their associated tests, and the results in a traceability matrix.
  • A validation release summary report provides comprehensive documentation of all requirements, test status, and test results.
  • Release previews provide AVM status, corresponding test case IDs, and comments cross-referenced in release documents to facilitate impact analysis and promote continuous validation.

Partner voices

Building a stronger network

Hear what our customers and partners are saying about Automated Validation Manager.

Hear what our customers and partners are saying about Automated Validation Manager.

TraceLink’s Automated Validation Manager (AVM) helps companies implement a lean, risk-based approach to software validation while providing the documentation needed to meet compliance and audit trail requirements.

Kirsten Peterson

Manager, Regulatory & Quality Compliance

TraceLink Inc.

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For Internal 32
Pharma Industry Mandates are Predictably Unpredictable

Automated Validation Manager is an automated validation service for pharmaceutical companies and contract manufacturers seeking to meet stringent regulatory and GxP compliance standards. Automated Validation Manager helps organizations ensure continuous compliance.

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