Check Yourself Before You Wreck Your GAMP 5 Audit | Valkit.ai
Check Yourself Before You Wreck Your GAMP 5 Audit
Master your GAMP 5 checklist: V-Model, categories, risks, AI/cloud updates & audit pitfalls for pharma compliance.
Steve Ferrell·
What Is a GAMP 5 Checklist (And Why Your Next Audit Depends on It)
A GAMP 5 checklist is a structured set of validation activities used to prove that computerized systems in regulated industries — like pharma, biotech, and medical devices — are safe, compliant, and fit for their intended use. Here's a quick overview of what it covers:
Core GAMP 5 Checklist Items:
Classify your system into the correct GAMP software category (1, 3, 4, or 5)
Conduct a risk assessment based on patient safety, product quality, and data integrity impact
Develop a User Requirements Specification (URS) aligned to intended use
Evaluate and select vendors against regulatory and quality criteria
Implement change control and configuration management
Ensure data integrity and security — audit trails, access controls, electronic signatures
Train users and create SOPs
Conduct periodic reviews and revalidation
Establish maintenance, support, and retirement plans
If your computerized systems aren't validated under a solid GAMP 5 framework, you're not just risking a failed audit — you're risking patient safety and product quality. GAMP 5 (Good Automated Manufacturing Practices, 5th issue) is the globally recognized industry standard published by ISPE. It provides a risk-based approach to ensuring your GxP computerized systems are compliant, high quality, and fit for use throughout their entire lifecycle — from initial concept all the way through to retirement.
It's not a regulation. But regulators worldwide, including the FDA, expect validated systems. GAMP 5 is the practical, defensible method most regulated organizations use to meet that expectation — efficiently and without over-engineering the process.
The stakes are real. A validation program that's too thin leaves gaps that auditors will find. One that's too heavy wastes months of time and thousands of dollars testing things that don't matter. Getting the balance right is exactly what this checklist is designed to help you do.
Steve Ferrell
Chief Product Officer
I'm Stephen Ferrell, Chief Product Officer at Valkit.ai and a contributing author to the GAMP 5 Second Edition — I've spent over two decades helping hundreds of regulated organizations build and execute defensible GAMP 5 checklists across CSV, CSA, and broader GxP environments. Let's walk through everything you need to check before your next audit.
The Core Pillars and V-Model of GAMP 5 Compliance
To navigate a gamp 5 checklist successfully, we first have to understand the philosophy behind it. GAMP 5 isn't about mindlessly checking boxes; it’s about Quality Risk Management (QRM) and science-based decision-making. The International Society for Pharmaceutical Engineering (ISPE) GAMP Guide emphasizes that we should focus our efforts where the risk to the patient is highest.
The framework rests on five core pillars:
Product and Process Understanding: You can't validate what you don't understand. You must know how the system supports the underlying GxP process.
Lifecycle Approach within a QMS: Validation isn't a "one and done" event. It starts at the "Concept" phase and follows the system through "Project" and "Operations" until "Retirement."
Scalable Lifecycle Activities: This is the "secret sauce." We scale the amount of documentation and testing based on the risk and complexity of the system.
Science-Based Quality Risk Management: We use data and critical thinking to decide what to test.
Leveraging Supplier Involvement: Why repeat work the vendor has already done? If a supplier has a robust Quality Management System, we should leverage their documentation to save time and money.
At the heart of this is the V-Model. On the left side of the "V," we define what we need (URS, Functional Specs, Design Specs). On the right side, we verify that we actually got it (IQ, OQ, PQ). The GAMP 5 Guide 2nd Edition has modernized this, acknowledging that the "V" isn't always a straight line—it can be iterative, supporting Agile and incremental development.
Classifying Your Systems: The GAMP 5 Software Categories
Before you start writing test scripts, you must categorize your software. This classification determines the "depth" of your gamp 5 checklist. If you treat a simple calculator like a custom-coded ERP system, you’ll drown in paperwork. Conversely, if you treat a complex LIMS like a basic spreadsheet, an auditor will have a field day.
GAMP Category Description Examples Validation Effort Category 1 Infrastructure Software Operating systems, database engines, firewalls Low (Verify installation/version) Category 3 Non-configurable Software COTS (Commercial Off-The-Shelf) software used as-is Medium (Focus on URS and OQ) Category 4 Configurable Software LIMS, ERP, SCADA, MES High (Focus on configuration and business process) Category 5 Custom (Bespoke) Software Custom-built apps, complex macros, ladder logic Very High (Full lifecycle, design specs, code review)
Note: Category 2 (Firmware) was retired in GAMP 5; firmware is now typically treated as Category 3 or 4 depending on its complexity.
For systems like a LIMS (Laboratory Information Management System), we usually see a Category 4 classification. You aren't changing the source code, but you are configuring workflows, access roles, and report templates. Your gamp 5 checklist for a LIMS must reflect these specific configurations.
The Ultimate GAMP 5 Checklist for Regulated Industries
Now, let's get into the nitty-gritty. Whether you are in Scotland or Indiana, the regulatory expectation for "intended use" is the same. This checklist ensures you meet the requirements of FDA 21 CFR Part 11 and EU Annex 11.
Vendor Evaluation: Do not skip this. You need to verify that your vendor follows a software development lifecycle (SDLC). If they don't have a QMS, the burden of proof falls entirely on you.
Data Integrity Controls: Does the system support ALCOA+ principles? You need to verify audit trails (who did what and when?), electronic signatures, and strict access controls.
IQ/OQ/PQ Activities:
IQ (Installation Qualification): Is it installed correctly? (Server specs, folder permissions, database connection).
OQ (Operational Qualification): Does it work as the vendor says it should? (Testing functional requirements).
PQ (Performance Qualification): Does it work for your specific process? (Testing the end-to-end workflow in your environment).
Change Control: Once the system is "live," any change—no matter how small—must be documented, assessed for risk, and potentially re-validated.
Configuration Management: You must be able to "rebuild" the system to its validated state. This means keeping track of versions, patches, and settings.
System Retirement: How will you migrate the data? How long must you keep the old records accessible?
Essential Documentation for Your GAMP 5 Checklist
If it isn't documented, it didn't happen. Here are the "Must-Haves" for your validation package:
User Requirements Specifications (URS): This is the most important document. It defines what the system must do. If a requirement isn't in the URS, you shouldn't be testing it.
Functional Specifications (FS): This explains how the system will meet the requirements.
Design Specifications (DS): (Required for Category 5) This gets into the technical architecture.
Traceability Matrix (TM): This is the auditor's favorite map. It links every requirement in the URS to a functional spec and, ultimately, to a test script and a "Pass" result.
Validation Master Plan (VMP): This is the high-level strategy. It tells the auditor, "Here is how we validate systems at our company."
Risk Assessment and Training Steps
We use a science-based risk assessment to prevent "death by documentation." By identifying high-risk functions (those that directly impact patient safety or data integrity), we can focus our heavy testing there.
Impact Analysis: If this function fails, does the patient get the wrong dose? Does the record become untraceable? If yes, it's high risk.
Mitigation: If a risk is too high, can we add a procedural control (like a second person's signature) or a technical control (like a system lockout)?
Personnel Competency: You can have the best system in the world, but if your team isn't trained, it's a compliance nightmare. Your gamp 5 checklist must include verified training records and approved Standard Operating Procedures (SOPs).
Navigating the GAMP 5 2nd Edition: AI, Cloud, and Agile
The world has changed since the original GAMP 5 was published in 2008. The 2nd Edition (2022) is a massive leap forward. It moves us away from "Computer System Validation" (CSV) toward Computer Software Assurance (CSA).
What’s the difference? CSA focuses on "assurance" rather than just "documentation." It encourages us to use critical thinking to reduce the amount of scripted testing for low-risk features. At Valkit.ai, we’ve built our platform to align perfectly with this shift. By Delivering CSA with ValKit AI, we help companies automate the tedious parts of the gamp 5 checklist, like generating traceability matrices or cloning validation sets for similar systems.
The 2nd Edition also explicitly addresses:
Cloud Computing and SaaS: How to maintain control when the software is hosted by someone else.
Artificial Intelligence (AI) and Machine Learning (ML): Validating systems that "learn" and change over time.
Agile Development: Moving away from the "Waterfall" approach to support faster, iterative releases.
Open-Source Software (OSS): Strategies for managing the risks of non-proprietary code.
Common Pitfalls: The "Deadly Sins" of GAMP Implementation
Even with a gamp 5 checklist, things can go wrong. Here are the "Deadly Sins" we see most often in the field:
Over-testing Low-Risk Features: Testing the "Print" button with the same rigor as the "Release for Sale" button. It’s a waste of resources.
Lack of Ownership: Treating validation as something the "QA Department" does. The business owners must own the system.
Treating Validation as a One-Time Event: Forgetting that validation status must be maintained through change control and periodic reviews.
Ignoring Supplier Audits: Blindly trusting a vendor because they have a "GAMP 5 Certified" sticker (hint: there is no such thing as a GAMP 5 certificate for software).
Weak Change Control: Making "emergency fixes" to the production environment without documenting them. This is the fastest way to get a Warning Letter.
Failing to Apply Critical Thinking: Following a template blindly without asking, "Does this actually make sense for our process?"
Frequently Asked Questions about GAMP 5 Checklists
How do I determine if my system needs a full or reduced GAMP 5 checklist?
The decision is based on two factors: System Complexity (GAMP Category) and Regulatory Impact (Risk). A Category 3 system with low impact (e.g., a training record logger) requires a reduced checklist—mostly URS and a basic OQ. A Category 4 system with high impact (e.g., an ERP system managing batch releases) requires a full, rigorous checklist including URS, FS, Risk Assessment, TM, IQ, OQ, and PQ.
What are the biggest changes in the GAMP 5 2nd Edition for 2024?
The biggest shift is the emphasis on Computer Software Assurance (CSA) and the integration of modern tech. It encourages the use of automated testing tools and "unscripted testing" for low-risk scenarios. It also provides much-needed guidance on how to handle AI/ML, Blockchain, and Cloud Service Providers. The focus has moved from "creating documents for auditors" to "ensuring the system is fit for use."
How does GAMP 5 address 21 CFR Part 11 and ALCOA+ principles?
GAMP 5 is the "how-to" guide for meeting the "what" of 21 CFR Part 11. It provides the framework for implementing the technical controls required for Data Integrity. By following the GAMP lifecycle, you ensure your records are ALCOA+: Attributable, Legible, Contemporaneous, Original, and Accurate (plus Complete, Consistent, Enduring, and Available).
Conclusion
Navigating a gamp 5 checklist doesn't have to be a nightmare of endless paperwork and missed deadlines. By focusing on risk, leveraging your suppliers, and embracing the modern CSA approach, you can build a validation program that is both defensible and efficient.
At Valkit.ai, we live and breathe this stuff. Our AI-powered digital validation platform is designed to take the heavy lifting out of GAMP 5 compliance. We help pharmaceutical, biotech, and medical device companies reduce their validation costs by up to 80% and turn weeks of manual documentation into hours of automated assurance.
Whether you need to clone a validation set for a new site or use smart automations to maintain your validated state, we have the tools to help you stay compliant without the headache. Don't wait for an auditor to find the gaps in your program.
Ready to automate your GAMP 5 compliance? Visit us at https://valkit.ai and let’s get your systems audit-ready today.
