0.1
75
Document Control
Control SOPs, templates, trackers, forms, master lists, versioning, review, approval, distribution, archiving, and retirement.
View toolkitStage 0
Enterprise drug-development operating system
Cross-functional governance and quality systems used across the full drug-development lifecycle.
What this stage covers
Document control, accountability, training, vendor oversight, quality risk, data integrity, and programme governance.
How it helps your team: Create one controlled operating foundation across teams and development stages.
12 toolkits
Choose the operational area you need
0.2
65
Roles, Responsibilities & Delegation
Define ownership, accountability, delegation, back-up coverage, and cross-functional responsibility.
View toolkit0.3
65
Training & Competency Management
Ensure personnel, vendors, affiliates, and consultants are trained and competent.
View toolkit0.4
66
Vendor Qualification & Oversight
Qualify, monitor, audit, and govern vendors across PV, clinical, nonclinical, CMC, data, statistics, CROs, labs, and CMOs.
View toolkit0.5
65
Safety Data Exchange Agreements
Define safety data exchange obligations between MAHs, CROs, vendors, licensing partners, co-marketers, and service providers.
View toolkit0.6
55
KPI & Performance Management
Monitor operational performance, quality, compliance, escalation triggers, and continuous improvement.
View toolkit0.7
55
Regulatory Intelligence
Monitor global and local regulatory changes and assess implementation impact.
View toolkit0.8
75
Deviation, Issue & CAPA Management
Manage deviations, quality issues, process failures, root causes, corrective actions, preventive actions, and effectiveness checks.
View toolkit0.9
76
Audit & Inspection Readiness
Prepare for internal audits, vendor audits, sponsor audits, GCP inspections, GLP inspections, GMP inspections, PV inspections, and pre-approval inspections.
View toolkit0.10
65
Quality Risk Management
Apply risk-based control across clinical, CMC, nonclinical, regulatory, PV, and quality systems.
View toolkit0.11
76
Data Integrity & Computerised Systems Control
Control data integrity, audit trails, access, backup, system changes, and computerised systems.
View toolkit0.12
76
Integrated Development Program Governance
Govern the whole asset development programme from discovery to launch.
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