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Issue Management and CAPA

Each and every manufacturer is required to conform to various levels of product safety and quality. No matter whether these safety and quality standards are driven by consumer desires, or are legally mandated, each manufacturer must both comply with these standards and effectively resolve any possible issues so as to avoid potentially devastating results.

Many of the corrective and preventative actions (CAPA) software solutions available today are stand-alone applications that require additional technology and manpower expenses. Because stand-alone software may result in a disconnect between critical pieces of information and the probability of discordant manual processes, their use has the potential of negatively impacting the timely solving of product quality issues, and can also increase the risk of repeating problems

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Unlike stand-alone programs, Siemens’ CAPA software provides closed-loop issue management and resolution built on a scalable foundation, allowing users to identify, analyze and share critical product quality data across the entire company platform. Design, manufacturing, and quality improvement teams share their efforts within a consistent framework that allows for direct access to the critical control points of effective CAPA solutions.

Key Capabilities and Benefits

Capabilities

  • All CAPA workflow deliverables, issues, and decisions are made and resolved in a single accessible platform
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  • Intuitive user experience may be tailored to the specific needs of the individual manufacturer.
  • Reporting methods may be customized.
  • The dashboard has drill-down capabilities.
  • All lifecycle elements are accessible through search functions.
  • Business processes may be automated via easily configured workflows and embedded change management procedures.
  • All tasks and sign-offs have a single-view.
  • Information relative to resolved issues within the PLM environment may be captured and re-used.

Program Benefits

  • The automation of non-value added tasks reduces or eliminates manual work.
  • Configurable workflows, centralized data, and automated notifications assist in reducing issue resolution time.
  • Common, repeatable processes are demonstrations of standard compliance and improve operational consistency.
  • Stakeholder-wide access to issue-resolution information increases the returns on investments.
  • Company key decisions and specialized know-how rank as assets in the firm’s investments.
  • Re-usability of captured knowledge leads to smarter decision-making.
  • The ability of users to access prior issues and achieved solutions, and to trace all the new/corrected and reference items, reduces audit confusion.
  • Preventative actions that can be utilized in the development of next-generation products reduces the costs inherent in carry-over product quality issues.
  • Eliminating the need for additional tracking systems reduces IT expenditures.

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