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Computer system validation: Efficient and safe validation in pharma, medical technology and biochemistry

Computer system validation (CSV) is a crucial step in ensuring compliance in regulated industries such as pharma, biochemistry and medical technology. Find out everything you need to know here.

Table of Content

What is Computer System Validation?

Computer system validation (CSV) ensures that computer systems in regulated industries such as pharmaceuticals, biochemistry and medical technology operate reliably and in compliance with the law. It ensures that all data is processed correctly and securely and helps to avoid risks to product quality and patient safety. Tests and documentation prove that the systems function perfectly. This ensures that computerized systems work correctly and safely according to their intended use.

Why is computer system validation important?

Computer system validation is important because it ensures that systems are reliable and error-free, which is crucial in regulated industries such as pharmaceutical and medical technology. Without validation, undetected errors or data loss could occur, jeopardizing product quality, patient safety and regulatory compliance. It therefore not only protects companies from legal and financial risks, but also people’s health.

Important regulations

Depending on your industry, there are different regulations that you must observe. Here is an overview of the most important ones:

FDA 21 CFR Part 11 (USA)

Relevant for: Pharma, medical technology, biochemistry

This regulation governs how companies must handle electronic records and electronic signatures. It ensures that data is authentic, unalterable and traceable, particularly in the production, testing and documentation of medicinal products, medical devices and biochemical processes.

EU-GMP Annex 11 (Europe)

Relevant for: Pharma, medical technology, biochemistry

Annex 11 describes the requirements for computerized systems used in pharmaceutical manufacturing and medical devices in the EU. It ensures that these systems are validated and that data is stored correctly to ensure compliance with GMP guidelines.

GAMP (Good Automated Manufacturing Practice)

Relevant for: Pharma, medical technology, biochemistry

GAMP provides guidelines for the validation of computer-aided systems in the production of automated processes. It recommends a risk-based approach that focuses on critical systems and processes and thus reduces the validation effort. GAMP is used in all three industries to ensure efficient and compliant production.

ISO 13485

Relevant for: Medical technology

This standard regulates quality management systems for the manufacture of medical devices. It requires the validation of computerized systems used for product development, manufacturing and quality control of medical devices to ensure the safety and effectiveness of the products.</span

GxP-Regulations– GMP, GCP, GLP

Relevant for: Pharma, Biochemistry

GxP comprises various good practice guidelines (Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice) that ensure that products and processes in the pharmaceutical and biochemical industry meet the highest quality standards. CSV is essential to ensure compliance with these standards.

ICH Q7 (GMP for active substances)

Relevant for: Pharma

This guideline of the International Conference on Harmonization (ICH) regulates good manufacturing practice for active pharmaceutical ingredients. It requires the validation of computerized systems used in the manufacture and quality control of active pharmaceutical ingredients to ensure product quality.

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Procedure and phases of the CSV

A computer system validation usually runs in 8 phases:

1. Planning phase

In this phase, a validation plan is drawn up that defines the objectives, responsibilities, schedules and systems to be validated. A risk analysis is carried out to identify the critical functions of the system.

2. Definition of requirements (URS)

The User Requirements Specification (URS) is defined to determine which functions and services the system must fulfill.

3. Design qualification (DQ)

Verification and documentation that the system design meets the requirements and is technically correct.

4. Installation qualification (IQ)

Verification that the system has been properly installed and that all components have been correctly implemented.

5. Operational qualification (OQ)

Testing of the system to ensure that it works according to specifications and that all specified functions are performed correctly.

6. Performance qualification (PQ)

Checking the system performance under real operating conditions to ensure that the system meets the requirements in daily use.

7. Report and release

Final documentation of the results of all tests and qualifications. After successful testing, the system is released for operation.

8. Change control and maintenance

After validation, all changes to the system are monitored and documented by a change management system to ensure ongoing conformity.

Advantages of computer system validation

Even though computer system validation can be a nuisance, it offers a number of important advantages:
  • Ensuring compliance
    CSV ensures that companies meet legal and regulatory requirements (e.g. FDA, EU GMP). This protects against penalties, recalls or production stoppages that could result from non-compliance.
  • Data integrity and security
    Computer system validation ensures that all data captured, stored and processed in the system is correct, complete and secure. This reduces the risk of data manipulation and ensures the reliability of processes.
  • Traceability and documentation
    Computer system validation ensures complete documentation of all processes and system changes. This transparency is not only important for audits and inspections, but also for internal quality management.
  • Protecting patient safety and product quality
    Particularly in the pharmaceutical and medical technology industry, CSV plays a key role in ensuring patient safety by making sure that all systems associated with the manufacture of medicines or medical devices work flawlessly and safely.

Methods for computer system validation

There are various methods for computer system validation. We briefly present the most popular methods here:

V-model (validation method)

The V-model is a widely used method in computer system validation. It represents a sequential validation in which each phase of the development process (e.g. specifications, design) is checked by a corresponding test phase (e.g. system tests, acceptance tests). This ensures that each requirement is tested and validated.

Risk-based approach

With this approach, validation activities are concentrated on the most critical system functions and risks. By conducting a risk analysis, resources can be focused on the areas with the highest risk to product quality and compliance, making the validation effort more efficient.

Agile method (flexible validation approach)

Die agile Methode bringt frischen Wind in die Computersystemvalidierung und eröffnet eine flexible Alternative zum traditionellen, linearen Ansatz. Im Unterschied zu starren Validierungsprozessen setzt die agile Methode auf iterative Entwicklung und ständige Anpassung. Das bedeutet, dass Anforderungen und Validierungsmaßnahmen regelmäßig überprüft und angepasst werden – perfekt für dynamische Projektumgebungen. So können Änderungen zeitnah integriert und durch kontinuierliche Tests jederzeit abgesichert werden. Mit dieser Methode wird die Validierung lebendig und bleibt flexibel, ohne Kompromisse bei Compliance oder Qualität.

GAMP 5 (Good Automated Manufacturing Practice)

GAMP 5 provides a risk-based, practical guide for the validation of computerized systems in automated manufacturing. It promotes an approach that focuses on critical systems and recommends the adaptation of validation requirements based on the risk potential of a system.

Typical errors and challenges with CSV

Over the last 15 years, we have implemented hundreds of CSV projects. In the process, we have noticed typical errors and challenges. These are typical:

Inadequate project management without planning

CSV requires thorough planning, including the definition of responsibilities, timelines and detailed system requirements. Often the validation process is started without a clear strategy or insufficient resources, leading to delays and inefficiencies.

Unclear or incomplete requirements documentation (URS)

It is crucial that all requirements for the system are clearly defined and documented so that they can serve as a basis for testing and validation. If the User Requirement Specifications (URS) are incomplete or unclear, it will be difficult to successfully complete the validation process.

Excessive focus on documentation instead of actual testing

Validation must be proven by actual system tests, not just by extensive documentation. Documentation should support the testing process, not replace it. Some organizations focus too much on creating documents to meet regulatory requirements, neglecting to perform comprehensive, real-world testing.

Lack of risk analysis

A risk-based approach is crucial in order to focus validation on critical system functions and avoid unnecessary tests. Without a risk analysis, too much effort is often placed on non-critical areas. A thorough risk assessment is often neglected to identify critical areas and utilize resources efficiently.

Our services

Do you only want external advice? Or the all-round carefree package? Or just someone to manage your project and steer it in the right direction? No matter what it is. We have the right service for you!

Consulting and Coaching

Our consulting and coaching services support you in making your CSV processes more efficient and secure – without operational intervention. We offer education, training and management consulting to help you better understand CSV and implement it yourself. With our guidance, checklists and targeted support, you can improve your internal processes so that your team is optimally prepared for validation.

Complete implementation

We offer a comprehensive service in which we take over the entire validation process from planning to successful implementation. Whether planning, preparing validation documentation or carrying out the necessary tests – we manage the entire project so that you can concentrate on your core business. Our experience ensures a smooth and efficient validation that meets all regulatory requirements.

Project and integration management

Our experts take over the complete project and integration management for your CSV project. With clear milestone planning, precise tracking and management of all activities, we ensure that your project runs according to plan and that all requirements are met on time. We offer you structured and transparent project management to ensure that every detail of your validation project is implemented in the best possible way.

Test- and Defect-Management

We dothe test and defect management of your project by defining a customized test strategy tailored to the specific requirements of your system. By controlling and monitoring test progress and efficiently managing corrections, we ensure that all tests are successfully completed and potential defects are quickly resolved to ensure the quality and reliability of your systems.

More customer testimonials

Elisabeth Kohm

Leiterin Qualitätsmanagement und Qualitätssicherung, HMS Analytical Software

Daniel scales processes precisely to company-specific characteristics and accompanies each project with a positive and motivating manner.
Andreas Etges

Business Project Leader – Boehringer Ingelheim

A guarantee for success and outstanding performance in highly regulated projects.
Markus Schwarz

Project Manager – Transformation Program – Boehringer Ingelheim

With extensive knowledge and project experience, the central point of contact for all validation issues.
Jens Fuellbier

Head of GBS Governance, Enable. & Strategy – Boehringer Ingelheim

Daniel brings the highest added value through his expertise and commitment to validation and compliance.
Michiel Wannet

Senior Principal, Infosys Consulting

Daniel transforms complex challenges into clear, practical solutions and inspires the highest quality.
Heidelinde Hecher

Quality Operation Specialists Computer Systems and Document Management, Boehringer Ingelheim

A patient expert who goes beyond expectations and successfully completes even the most complex projects.
Boris Skoflic

Senior Consultant

A committed team player who leads every project to success with in-depth knowledge and expertise.
Patryk Rutkowski

Tollgate Review Lead, Novartis

A team leader who turns individuals into a cooperative and successful team.
Maywand Atrafi

Director, Envocon B.V.

An excellent validation manager with extensive GxP knowledge and a positive, helpful attitude.
Tony Baker

CFO Takeda

A validation manager who impresses with enthusiasm and outstanding expertise and meets the highest standards.

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