Computer system validation: Efficient and safe validation in pharma, medical technology and biochemistry
Table of Content
What is Computer System Validation?
Why is computer system validation important?
Important regulations
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.
A selection of our satisfied customers
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
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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
V-model (validation method)
Risk-based approach
Agile method (flexible validation approach)
GAMP 5 (Good Automated Manufacturing Practice)
Typical errors and challenges with CSV
Inadequate project management without planning
Unclear or incomplete requirements documentation (URS)
Excessive focus on documentation instead of actual testing
Lack of risk analysis
Our services
Consulting and Coaching
Complete implementation
Project and integration management
Test- and Defect-Management
More customer testimonials
Elisabeth Kohm
Leiterin Qualitätsmanagement und Qualitätssicherung, HMS Analytical Software
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