Out of Specification (OOS) Software – MasterControl

Manufacturing Recipe Management Software

What is Out of Specification (OOS) Software?

The MasterControl Quality Management System (QMS) enables effortless adherence through its handling of products that fall outside the specified parameters.

  • The interconnected OOS software facilitates compliance with U.S. Food and Drug Administration (FDA) regulations and ISO standards.
  • Regulated manufacturers must adhere to current good manufacturing practices (CGMPs) which entail following specifications defining product parameters.
  • In instances where a product is found to be out-of-specification (OOS), a company is obligated to conduct an investigation and meticulously record the findings.

Why Out of Specification (OOS) Software?

An out-of-specification (OOS) event doesn't occur in isolation. Hence, we link it to all of your quality procedures.

  • Corrective Action Preventive Action (CAPA)

    • OOS can indicate underlying issues
    • CAPA might be needed for correction/prevention
    • CAPA form initiated from OOS product
    • Reduces human error
    • Ensures continuity
  • Audit Management

    • Importance of effective OOS (Out of Specification) management for compliance
    • Documentation presentation during audits for OOS cases
    • Integration of audit management system with Quality Management System (QMS)
    • User-friendly access to required information for auditors
    • Timely availability of necessary data for audits.
  • Document Control

    • OOS (Out of Specification) process involves recording, investigating, and resolving.
    • Involves documentation and approvals.
    • Challenge with physical paper-based approach.
    • Better solution: Document control system integration.
    • Features needed: Automated routing, delivery, escalation, approval..
  • Correct an OOS During Manufacturing

    • Tension between quality and manufacturing due to events like OOS
    • In-line quality event management alleviates this tension
    • MasterControl Manufacturing Excellence offers a solution
    • OOS during manufacturing fixed without process slowdown.
  • The Perks of Platform Quality Event Management

    • Product life cycle consists of multiple phases: quality and manufacturing, product development, clinical, regulatory, supplier, and postmarket.
    • Platform-based quality event management tools are effective throughout these phases.
    • A major benefit of a unified cloud-based quality event management software is its constant audit-readiness.
    • Predefined value choices guarantee data completeness and accuracy.
    • Documentation remains clear and accessible even remotely.

Out of Specification (OOS) Software Dealer/Reseller

Factonity Systems Pvt Ltd is a full service dealer & reseller of Out of Specification (OOS) Software. Apart from software licensing, we also provide authentic software training, local technical support and statistical consulting.

Please contact us for:

  • Latest MasterControl's OOS Software pricing information / quotation
  • Demo of MasterControl's OOS Software and free initial consultation
  • Lean Six Sigma + MasterControl's OOS Software bundled training with licensed of demo software
  • Post sales local technical support

Who uses Out of Specification (OOS) Software?

MasterControl is utilized by global clients to mechanize fundamental business procedures. The out-of-specification product collaborates seamlessly with the remaining Quality Management System (QMS) to accelerate compliance procedures and hasten time-to-market.

Which industries use Out of Specification (OOS) Software?

Leading corporations utilize MasterControl's OOS Software. Below are a few industries that leverage the capabilities of MasterControl's OOS Software:

  • Medical Equipment Manufacturing
  • Biotechnology Research
  • Semiconductor Manufacturing
  • Chemical Manufacturing

Out of Specification (OOS) Software - MasterControl