Effective lab management with real time analysis

As per two phase FDA guidelines for OOS, it is important that potential quality issues are effectively resolved after phased investigation, root cause analysis, change control or CAPA.

QEdge offers electronic record management for OOS and OOT record with ability to store and retrieve related document as well as complete link with resulting outcome in terms of change control or CAPA or other quality processes.

QEdge also offers in-built flexibility to design and implement the system in such a way, that in-between processes and workflow within the organization can be customised under generic OOS and OOT management software solution.

Key Benefits

  • Compliance with pharmaceuticals and biotech industry regulations including GMP, 21 CFR part 11 and Annex 11
  • Reduction of risk of loosing important data for closed loop OOS and OOT implementation
  • Helps in avoiding repeat issues
  • Improves efficiency and reduce operational costs of managing change control implementation activity
  • Reduces the risk of product non-confirmance and ultimately helps in reducing market complaints and deviations
  • Inter departments and Intra department transparency at operational level is greatly improved
  • Offers controlled environment without sacrificing flexibility
  • Web based system can be accessed across sites without individual installations
  • Central database provide full control and traceability from regulatory perspective