Validation Management

Standardising CQV, Protocol Execution & Compliance with goPLIMS

Executive Summary
  • All coordination relies on endless meetings, manual follow-ups, and people-dependent systems, driving high overhead costs
  • Teams operate in silos with incompatible tools with no central collaboration platform linking diverse teams
  • Paper-based or Excel-driven Management forces manual coordination, duplicate data entry, and administrative overload
  • No real-time visibility into project status, causing surprise delays, reactive decision-making, and cost escalations.
  • Organisations face challenges with real-time visibility, data integrity, and regulatory readiness (FDA, EMA, MHRA, WHO)
Business Challenge
  • People-dependent systems, endless meetings, manual follow-ups
  • Teams working in silos and individual teams’ dedicated trackers
  • Manual processes and paper based systems lack alignment and knowledge retention
  • People-dependent systems with manual follow-ups slowing down progress and increased bottlenecks
  • Delayed handover to operations because validation data is not integrated with commissioning
The goPLIMS Solution
  • Centralised platform to empower teams, provide global collaboration and seamless integration
  • Single platform to integrate all project teams with global visibility
  • Centralised Digital platform with multiple workflows with inbuilt data integrity/security
  • Platform-based collaboration with role-based access and documented workflows & automated notifications
  • Configurable modules for validation planning, execution, and close-out
goPLIMS Modules

ActionR – Team-based actions, micro-scheduling, automatic remainders & meeting minutes

RFI-M – Structured queries between CQV, engineering and QA

FormM – Digital forms & checklists, supporting onsite execution and digital data

DecisionM – Decision logging for protocol changes, approvals, and acceptance

ChangeM / DiscrepM – Change management & exception • management with e-signatures

EDocM & ESignM – Central document management, controlled protocols, digital approvals

TrackR – Live dashboards for validation progress, readiness, and close-out

PunchM – Central management of snags, defects & punchlists, linked to protocol execution

Key Outcomes

Metric

Document Routing & Approvals

System status visibility

Team’s coordination

Digital management systems

Target KPI

70% faster

Real-time

Seamless

75% faster

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