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Reduce validation costs and efforts in medical device manufacturing

Pharmaceuticals, biotech or medical device companies, or any companies in regulated industries, need to follow certain guidelines like European Union (EU) GMP Annex 11 and GAMP5. The Food and Drug Administration (FDA), EU and AMWHV require their regulations to be followed, which results in a formal validation procedure.

GAMP5 proposes to share templates and use a risk-based approach to evaluate the quality of mitigation measures. Siemens’ Polarion™ Portfolio Validation Template, enriched with out of the box content for Opcenter™ Execution MDD software, can reduce validation efforts by up to 50 percent, following the GAMP5 guideline.

Download this brochure to learn to significantly reduce validation efforts with templates and out-of- the-box-content.

Accelerate new software implementations using Polarion Portfolio Validation Template

Companies in regulated environments hesitate to implement new or changed applications due to unpredictable efforts with validation costs and resources. GAMP5 recommends using templates to reduce the validation efforts.

The benefits of using the Polarion Portfolio Validation Template with Opcenter Execution MDD software include paperless validation and automated traceability. A few options for using the template include:

  • Scalability from computer system validation to process validation

  • Preconfigured validation templates

  • Collaboration with other user groups

Download this brochure to learn how you can accelerate new software implementations using Siemens’ Polarion Portfolio Validation Template and Opcenter software.