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Maintain Quality Software Control and Compliance with AssurX Validation Management Services

Software validation is a critical requirement for a successful software implementation/upgrade but can be the most time-consuming and challenging phase of the process. AssurX Validation Management Services can help by providing custom validations to satisfy your organizational and regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, ISO 13485 and others.

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Validation Management Services

AssurX Validation Management Services offers adaptable and specifically structured expertise to increase the agility of validation activities associated with future enhancements and configuration changes. We provide our customers with evidence that substantiates that their quality processes consistently meet pre-determined requirements and quality attributes.

AssurX Validation Services Deliverables

Technical Documentation

Project deliverables or Technical documentation tend to be the most over worked and under estimated delivery in the software development processes.  Our team can relieve that pressure by creating and maintaining your companies technical documentation to ensure that each deliverable is on schedule and on budget.

Validation Planning

The AssurX Validation Management Services team will work with you to create a validation plan that establishes a disciplined and structured approach to your validation projects. In addition, Validation Services can assist with the overall risk-based strategy for achieving and maintaining a validated process. The team can help you identify and analyze the validation scope and approach, help identify resources, and gather solution and compliance requirements to ensure your organization is able to diminish costs and speed up implementation time.

Our expert Validation Management Services team works work closely with your Project Managers, QA and/or IT teams to configure a validation strategy that will diminish costs and speed up implementation time.

Automate and Execute IQ/OQ's

AssurX provides a comprehensive Installation Qualification (IQ) and Operational Qualification (OQ) Test Script that includes rigorous testing and documentation of the AssurX platform. AssurX Validation Management Services can automate or execute manually the IQ/OQ test scripts and perform any necessary configuration changes that are required to meet your organization’s regulatory requirements.

In addition to the IQ/OQ Test and Report that is on the AssurX Platform, our team can create and execute Operational Qualification Tests scripts for your installed solutions.  Our team of experts will ensure that the functionality defined in the Functional Specification is present, working correctly, and that there are no defects.

Process Qualification (PQ) Creation and Execution

AssurX provides an extensive library of Process Qualification (PQ) documentation for pre-configured solutions. Once your solutions have been customized, AssurX Validation Management Services will tailor the Process Qualification document to ensure that the critical aspects and functions of your configured process have been thoroughly tested. Each PQ has Requirements Traceability Matrix (RTM) built into the document that links requirements to the validation process. Our team ensures that all requirements defined for your system are tested in the PQ.

Additional Guidance Materials

AssurX offers online Help documentation including administration tutorial videos and user guides for each pre-configured AssurX solution to reduce the learning curve for the AssurX platform. AssurX Validation Management Services will create customized users guides that are specific to your organizations configured solutions and workflows.

Integrated Approach to Post-Release SDLC and STLC

In the post-release update/maintenance Software Design Lifecycle (SDLC), AssurX will run Software Testing Lifecycle (STLC) in tandem phases to identify and eliminate gaps in new functionality and ensure quality objectives are being met.

AssurX Validation Management Services provides traceability through every stage of the software development and software testing lifecycle to ensure complete testing and validation coverage.  Our process ties together the SDLC and the STLC stages to include requirement gathering and analysis, design, planning, development, testing, validation and deployment of the software life cycle to create an integrated approach for SDLC and validation.

Benefits of AssurX Validation Management Services

  • Reduce cost and time-to-completion with custom validations that satisfy regulatory guidelines.
  • Validation standards executed are in compliance with global regulations.
  • Scale to an unlimited number of users, processes and facilities.
  • Avoid gaps that can lead to observations and warning letters.
  • Reduce your time to go-live by leveraging the expertise of professionals with extensive practical experience.
  • A validation services team that operates independently from implementation services to eliminate any perceived bias in the process.
  • Utilize Validation Management Services as needed to minimize validation of future enhancements and configuration changes.​

Validation Management Packages

Create a validation plan that establishes a disciplined and structured approach to your validation projects.

User Requirement Specification (URS)

Functional Requirement Specification (FRS)

Functional Risk Profile (FRP)

Validation Test Plan

Requirement Traceability Matrix (RTM)

Operation Qualification (OQ) Validation Protocols

Execute Operation Qualification (OQ)

Process Qualification (PQ) Validation Protocols

Execute Process Qualification (PQ)

Execution Report

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Summary
Validation Services - Quality and Regulatory Compliance - QMS | AssurX
Article Name
Validation Services - Quality and Regulatory Compliance - QMS | AssurX
Description
Validation Services can be adapted and tailored to meet your organizational needs, from leveraging our extensive library to creating validations plans.
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Publisher Name
AssurX, Inc.
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