Managing a Quality Assurance department today does not only mean knowing GMP regulations, but being able to translate them into robust, documented and inspection-defensible processes.
This bundle has been designed as a true “operating system” for QA Managers, providing a complete methodological structure to govern the Pharmaceutical Quality System (PQS) according to international standards.
The included guides provide operational frameworks, checklists and decision-making models that help transform regulatory requirements into practical tools for everyday quality management.
Ideal for QA Managers, Qualified Persons (QP) and compliance professionals who must ensure a robust quality system and strong readiness for regulatory inspections.
GUIDES INCLUDED IN THE PACKAGE
This guide provides an operational framework to organize and govern the pharmaceutical quality system in alignment with EU GMP, FDA and ICH Q10.
It includes practical tools such as:
- PQS assessment checklist
- Quality system governance model
- Quality KPI monitoring framework
- Management Review operational structure
- Decision-making framework for QA activities
An operational guide for building an audit-ready Deviation & CAPA system.
Included templates:
- Deviation Investigation Report
- Root Cause Analysis Worksheet
- CAPA Design & Justification Template
- CAPA Effectiveness Check Plan
- Deviation & CAPA Trending Dashboard
- Risk Review Post-CAPA Template
- Audit Defense Checklist
- Regulatory Inspection Evidence Pack Checklist
A complete methodology to design and manage risk-based GMP internal audits.
Included templates:
- Audit Risk Matrix (Severity × Probability)
- Internal Audit Plan
- GMP Audit Checklist
- Audit Report Template
- CAPA Plan for audit findings
- Audit readiness documentation checklist
Operational tools for implementing Data Integrity (ALCOA+) in QC laboratories.
Included checklists and templates:
- HPLC Audit Checklist
- GC Audit Checklist
- Empower Audit Checklist
- LIMS Audit Checklist
- Data Review Checklist
- QC Data Integrity Self-Assessment
- QC Data Review Template
- Audit Trail Review Template
- DI Risk Assessment QC
A practical guide to the ICH Quality Trilogy and product lifecycle management.
Included templates:
- QTPP – Quality Target Product Profile
- CQA – Critical Quality Attributes Template
- FMEA Risk Assessment Template
- CAPA Template
- PLCM – Product Lifecycle Management Template
- Change Management Plan Template
WHY CHOOSE THIS BUNDLE
- 35+ operational checklists
Written by industry experts and based on real-world pharmaceutical experience.
- 20+ ready-to-use templates
Designed to be used directly within the Pharmaceutical Quality System, audit-ready and aligned with the latest regulatory expectations.
- Reduced documentation time
Do not start from a blank page. Use templates, checklists and logical frameworks already validated by industry experts.
- Risk-Based Approach
Each tool is aligned with ICH Q9 principles, allowing you to justify technical decisions with solid scientific rationale.
- Audit-Ready
The included checklists replicate the perspective of inspectors, helping you prepare your team and documentation to meet global inspection standards.
- Maximum Value
Get the best QA-focused guides with an immediate 30% saving compared to purchasing each guide individually.
Product Details
Format: 5 guides in PDF format, optimized for printing and consultation on tablet or PC.
Pages: Over 500 pages of technical content, checklists and operational models.
Updated: February 2026 – aligned with the latest standards from FDA, AIFA, ISO, ICH and GMP Annex guidelines.
Languages: ITA – ENG
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