Software Validation Services

Validation is often the most time-consuming phase of a software implementation or upgrade because many companies lack the resources and specialization necessary to meet the regulatory commitment for implementation, as well as supporting their day-to-day activities. Our validation services, performed by PeopleMED*, provide custom validation, consulting, and compliance services for donor centers and hospitals. Blood bank specialists and quality-certified professionals at PeopleMED have extensive product knowledge to help you design, develop, and execute your validation plan, risk analysis, and test cases. They can also provide regulatory, quality, and compliance assessments tailored to your facility.

*PeopleMED is a Haemonetics company.

Reduce the time and hassle associated with validation

PeopleMED‘s dedicated validation experts can work with you to help ensure your project is completed on schedule and on budget. You can also select from an array of custom validation packages to suit your organization’s specific needs.


What’s New: VALIDATION SERVICES ENHANCEMENTS

The following features are now available:

  • Multi-year, fixed-fee subscription plans for validation maintenance
  • Data conversion validation based on statistical analysis
  • Validation of new products, instruments, and analyzers, as well as non-Haemonetics software systems


Validation Plan
  • PeopleMED can help you develop a validation plan, including identifying and analyzing scope, approach, resources, schedules, the types and extent of activities, tasks and work items, and the approval process.

Risk Analysis

  • As a required component of validation procedures, PeopleMED will assess your level of risk based on the potential hazards posed by your specific system configuration and setup (according to your standard operating procedures). This risk assessment will then determine the level of validation effort needed.

Test Case Procedures

  • PeopleMED can provide custom test case procedures that meet the validation activity requirements for your organization including the documentation of input; expected output; actual output; acceptance criteria; whether the test passed or failed; the name, initials or other identification of the person performing the test; and the date the test was performed.

Test Case Execution

  • PeopleMED can perform your test case execution (i.e., the physical running and output documentation of individual test case procedures) and provide the necessary documentation to help ensure your compliance with validation regulations.

Validation Report

  • In accordance with FDA regulations and quality validation standard operating procedures, PeopleMED can provide a comprehensive validation report comprising a test results summary including variances or failed tests, amendments made to test cases of the validation plan, and an evaluation of the testing outcome. The report will also have a space for approvals.

With PeopleMED Validation Services, we can help you:

  • Get the most return on your investment in software systems
  • Reduce your time to ‘go-live’ by leveraging dedicated, focused, quality professionals
  • Allow your existing staff resources to focus on current operational productivity
  • Provide accurate evaluation of regulatory and quality compliance tailored to your facility
  • Identify and mitigate risks to reduce surprises after ‘go-live’
  • Access dedicated resources with fixed project costs and timelines
  • Rely on dedicated support and audit assistance for your validation activities
  • Leverage independent validation and an unbiased analysis for an improved validation experience

CONTACT HAEMONETICS

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