GAMP 5 ®
Template
For Pharmaceutical Project Validation &
Quality Risk Management
GAMP® 5 TEMPLATE
Introduction
Pharmaceutical project delivery happens in a complex and heavily regulated
environment. For process maturity and compliance, pharma developers, system
integrators, and suppliers are applying Good Automated Manufacturing Practice
guidelines to manage computerized and software-based systems in their
collaborative projects.
This GAMP 5 Template enables the documented management of computerized production systems
using PTC®’s Codebeamer technology. It supports pharma project delivery, systems validation, and
quality management all in one. The template helps apply a risk-based approach to GxP computerized
systems management. Traceability, accessibility, and advanced document management across
stakeholders helps simplify and accelerate audits. Use the template out of the box, or map your
processes and tailor the template to your organization’s individual needs. Define custom workflows for
all work items and documents, and use preconfigured or custom reporting options.
Use this template to cut costs and project times, identify and manage hazards and defects, and to
enable effective change management in GxP-compliant pharmaceutical project delivery. Reduce
waste, implement systemic risk management, and achieve GAMP® 5 compliance with optimal effort.
Cut Costs & Manage Hazards & Effective Change
Project Times Defects Management
GAMP® 5 TEMPLATE
The Specification, Design, and Verification Process
Good engineering practice
With permission from ASTM E2500-07 Standard Guide for Specification, Design
and Verification of Pharmaceutical and Biopharmaceutical Manufacturing
Product Knowledge Systems and Equipment, © ASTM Intermational
Process Knowledge
Operation &
Specification & Acceptance &
Requirements Verification Continuous
Design Release
Improvement
Regulatory
Requirements
Company Quality Risk Management
Requirements
Design Review
Change Management
This GAMP 5 template is intended for use by:
Pharmaceutical Systems Integrators Suppliers of automated
end users (pharma providing services systems (including
production for pharma hardware & software for
companies) producers the pharma industry)
Scope of this GAMP 5 Template for Pharma Validation & Quality Management:
1 2 3 4
Use Case 1: Use Case 2: Use Case 3: Use Case 4:
Pharma Quality Risk Quality Audit FDA 21CFR11
Validation Assessment and CAPA Requirements
Process Management and Compliance
Management Check
GAMP® 5 TEMPLATE
Use Case 1/
Pharma Validation Process Management
Maintain full control over every stage of the validation lifecycle using this
GAMP 5 Template. Link regulatory requirements to specifications and to test
cases, guaranteeing traceability across the validation chain.
The template provides adequate management control, change management, and a consistent
approach across systems from validation planning all the way through to reporting. From user
requirements through system design specifications and test cases for validation, the template comes
preconfigured with purpose-built trackers.
These data containers, as well as their underlying workflows, have been designed to suit the use cases
of pharmaceutical companies. Use trackers for planning & specification, project control, compliance/
QMS, and risk management out of the box, or adapt them to your needs as you see fit.
GAMP® 5 TEMPLATE
Use Case 2/
Quality Risk Assessment
Use a science-based risk management approach, focus on product and process
understanding, and apply Quality by Design concepts with the help of this GAMP 5
Template.
Dedicated Quality Risk Management artifacts and workflows help the implementation of a systematic
process for the assessment, control, communication, and review of hazards. Link risk assessment
artifacts to risk control work items in order verify the effectiveness of your mitigation actions, and use
this template to document all your risk-related processes.
Rely on automatically created risk matrix diagrams, or build custom dashboards to report on your
quality risk management activities.
GAMP® 5 TEMPLATE
Use Case 3/
Quality Audit and CAPA Management
Connect all your work items to corresponding GAMP standard requirements, and
build airtight audit checklists to validate your pharma systems.
Use this template to establish a trail of interlinked artifacts along project delivery (including user
requirements, functional, system, and software design specifications, as well as the test cases that
verify them).
Manage non-conformities and Corrective and Preventive Actions (CAPA) in a traceable manner. Access
informative example checklists, and create your own custom audit checklists based on relevant
regulatory requirements. Define and execute project verification plans, and simplify compliance audits
using this GAMP 5 Template.
GAMP® 5 TEMPLATE
Use Case 4/
FDA Title 21 CFR Part 11 Requirements
and Compliance Check
Codebeamer is a fully equipped electronic Quality Management System that
helps pharma users adhere to the FDA’s requirements on electronic quality
records and digital signatures.
Use this template to implement a digital, paperless eQMS that complies with Part
11 of Title 21 of FDA’s Code of Federal Regulations Part 11 (21CFR11).
Item-based reviews may be used on all artifacts within this template, letting users approve each
artifact with digital signatures that are equivalent to handwritten signatures. All 21CFR11 requirements
and the test cases that verify them are available within this template.
Map your intended use case, pick the appropriate requirements, and verify the correct functioning of
your system as per Title 21 CFR Part 11. Validate Codebeamer’s functionality around record generation,
audit trails, and digital signatures to achieve regulatory compliance with optimal effort.
Why use Codebeamer’s
GAMP 5 Template?
Save resources via Achieve paperless
Cut project cycle reducing human traceability in your
times significantly effort pharma projects
Integrate your
Comply with the collaborative
Simplify and requirements of lifecycle
accelerate GAMP 5 and (common platform
regulatory audits FDA Title 21 CFR for pharma users,
Part 11 system integrators, and
suppliers)
GAMP® 5 TEMPLATE
Initial Risk Assessment
Typical Use of Risk-Based Decision Making
R1
Potential
R7 Retention,
R2 R5 Migration,
Destruction
Planning Reporting
R6 R6
R3 R4
Retirement
Specification Verification
Changes
Configuration and/or Coding
Concept Project Operation Retirement
Functional Risk Assessment in
R1 Initial Risk Assessment R6
change control
Risk-based decisions Risk-based decisions when
R2 R7
during planning planning system retirement
R3 Functional Risk Assessments
Risk-based decisions during
R4
test planning
R5 Risk-based decisions during
planning of operational
activities
GAMP® 5 TEMPLATE
About Codebeamer
Codebeamer is an Application Lifecycle Management (ALM) platform with unique
configurability and product line configuration capabilities.
Codebeamer X is an integrated Engineering Lifecycle Management (ELM) platform
for life sciences companies with regulatory process & compliance support.
About PTC (NASDAQ: PTC)
PTC enables global manufacturers to realize double-digit impact with software
solutions that enable them to accelerate product and service innovation, improve
operational efficiency, and increase workforce productivity. In combination with an
extensive partner network, PTC provides customers flexibility in how its technology
can be deployed to drive digital transformation—on premises, in the cloud, or via its
pure SaaS platform. At PTC, we don’t just imagine a better world, we enable it.
Discover the benefits of
Codebeamer
Use Codebeamer to digitalize your GxP systems validation processes. Automate quality
risk documentation and accelerate GAMP® 5 audits.
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© 2023, PTC Inc. All rights reserved. Information described herein is furnished for informational use only, is subject to change without notice, and should
not be taken as a guarantee, commitment, condition or offer by PTC. PTC, the PTC logo, and all other PTC product names and logos are trademarks or
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gamp5-codebeamer-template
