ISO 80002-2 Computer System Validation Without Slowing Your Innovation

Keep Your Digitalization and Automation on Track

Implementing ISO 80002-2 does not have to slow down your digitalization or automation journey. We help organizations adopt this standard in a way that:

Supports innovation, not blocks it
Simplifies compliance instead of adding complexity
Keeps your company modern, agile, and audit-ready

“Compliance should never be the enemy of innovation. With the right approach, it becomes your accelerator.”

Practical Software Validation That Accelerates Your Digital Journey

Many companies hesitate to introduce new computer systems or automation technology because of doubts.

Questions often arise:

How do we prove compliance with ISO 13485 or ISO 80002-2?
Will we fail during an audit if our software is not validated?
Isn’t validation too complex, time-consuming, and expensive?

Typical situations we see:

Organizations hesitate before even starting digitalization projects.
Teams face audit findings because existing tools are not validated.
Great ideas for automation or software solutions get abandoned.

We know these challenges well; balancing compliance and innovation is never easy. But we will help you to keep compliance strong while letting innovation move forward.

“Concerns about validation should never stop you from improving your quality management system.”

System Validation Made Simple, Efficient and Compliant

We understand the doubts about computer system validation; we have seen them many times in medical device companies.

But here’s the good news:

Validation can be efficient and practical.
With the right methodology, it won’t slow you down.
Done properly, it even brings clear business benefits.

Our approach ensures that:

Your software validation passes internal and external audits
The process is optimized, focusing only on what really matters
You gain confidence and clarity instead of an additional burden

“We transform computer system validation from a painful obligation into a tool that strengthens your organization.”

How to Approach Computer System Validation (CSV)

Clear Guidance for Your Validation Journey

When it comes to computer system validation (CSV), many organizations ask the same questions:

Do we really need to validate this software?
How deep should the validation go?
What are the right steps to follow?

We will guide you through all such questions and give you clear advice on how to proceed. For years, we have supported medical device companies in digitalizing quality management systems, regulatory workflows, and technical documentation tools. For us, CSV is not theory, it is part of our daily work.

“Validation should be structured, practical, and focused, not overwhelming.”

Step 1: Simple Rules for Getting Started

We help you implement clear and easy rules so that any team can evaluate whether:

A tool or software falls under ISO 13485 or 21 CFR Part 11 validation requirements
The validation effort needs to be lightweight or more extensive
The validation scope is aligned with real regulatory expectations

Step 2: Building Practical Procedures and Records

Validation is only as strong as its documentation. We help you:

Establish documented procedures for computer system validation
Create a set of records to demonstrate compliance
Optimize existing processes that may be too complex or time-consuming

Step 3: Conducting Risk-Based Validation

Validation should focus on what matters most. Together we:

Define the scope of validation — what the system does and why it matters
Apply risk analysis to highlight the most critical features and failure points
Define requirements that reflect both compliance and business needs
Develop test plans and test cases to prove the requirements are met
Execute validation activities and collect evidence in structured reports

Step 4: Maintenance and Change Management

Validation does not stop once the system goes live. We guide you through:

Planning maintenance and monitoring activities
Defining change control processes so updates don’t compromise compliance
Managing system use across multiple departments without conflicts

Step 5: End-of-Life and System Retirement

When a system reaches its end, we support you with:

Defining retirement strategies
Preserving data integrity and compliance evidence
Ensuring no impact on connected processes or departments

“From planning to retirement, validation is a lifecycle, and we make sure every phase is covered.”

Computer System Validation in a Connected Regulatory World

Where CSV Is More Than Just Compliance

In today’s digital era, computer system validation is not only about proving that software works as intended. It also connects to:

Cybersecurity and information security
Data privacy and GDPR compliance
AI-based and AI-augmented quality management systems
Cloud-based tools and connected process control systems

“Validation can be your foundation for secure, reliable, and trusted digital transformation.”

Our holistic approach ensures your validation strategy also addresses these dimensions, protecting your organization against data breaches, vulnerabilities, and reputational damage.

Multiple Facets, One Strategy

Computer system validation has many faces. Depending on the system, environment, and use case, the validation strategy may differ.

We help you choose the right path by integrating requirements from overlapping standards and regulations, such as:

ISO 42001 – Artificial intelligence management systems, ensuring responsible use of AI in medical device environments
ISO 81001-5-1 – Cybersecurity framework for IT systems lifecycle, covering threats and vulnerabilities
GAMP 5 – Good Automated Manufacturing Practice for software in GMP-regulated environments
ISO 27001 – Information security management for on-premise and cloud systems
21 CFR Part 11 – Requirements for electronic records and electronic signatures in FDA-regulated environments

More Than Validation: Safeguarding Your Organization

With our expertise, you gain more than just regulatory compliance.

We help you:

Protect sensitive data and ensure GDPR compliance
Prevent unexpected AI system behavior that could disrupt operations
Maintain business continuity even under regulatory pressure
Safeguard your company’s reputation and financial stability

“Our validation strategies integrate the best practices of multiple standards to deliver compliance, security, and business resilience.”