Out of Specification (OOS) Software – MasterControl

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: