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  • Solutions
    • Quality Processes
      • Change Control
      • Deviation
      • Investigation
      • CAPA Management Software
      • Market Complaint
      • OOS and OOT
      • Pharmacopeial Change Control
    • Document Control
      • SOP
      • Protocol
      • Work Instruction
      • Specification
      • Controlled Copy Release (Doc Issuance)
    • Learning Management System
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OOS & OOT management software

Top 5 Mistakes While Handling OOS and OOT in Pharma Manufacturing
OOS & OOT management software
Top 5 Mistakes While Handling OOS and OOT in Pharma Manufacturing

Why OOS and OOT in Pharma Matter  In pharmaceutical manufacturing, OOS (Out-of-Specification) and OOT (Out-of-Trend) results are red flags that must be taken seriously. These results often signal issues in product quality, process consistency, or laboratory control—and regulators like the […]

by QEdge Team

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June 5, 2025
The Impact of Process Control on Reducing Out-of-Specification (OOS) Results
OOS & OOT management software
The Impact of Process Control on Reducing Out-of-Specification (OOS) Results

How Process Control Reduces OOS Results in Pharma Manufacturing  In pharmaceutical manufacturing, Out-of-Specification (OOS) results pose significant challenges, leading to production delays, increased costs, and potential compliance risks. An OOS result occurs when a product or raw material fails to […]

by QEdge Team

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April 14, 2025
What does a modern pharmaceutical quality management system look like
OOS & OOT management software
Still addressing out of specification/out of trend (OOS and OOT) manually?

FMCG, Food & Beverages and Pharmaceutical are few of the industries which are directly linked with the customers so they need to ensure the quality, efficacy and safety of their products. These industries now digital OOS and OOT. In-spite of […]

by QEdge Team

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September 29, 2016
necessary-record-specifications
OOS & OOT management software
Why is it necessary to record OOS & OOT?

Pharmaceuticals, healthcare and FMCG are few of the industries which need to meet stringent guidelines of various quality and regulatory authorities. FDA defined CGMP for each one of them to ensure that the end consumers are getting superior value. OOS […]

by QEdge Team

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June 2, 2016


QEdge Quality Management Software Suite

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