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Computer System Validation
Computer System Validation for Compliance, Quality & Safety
Why is computer system validation important?
Computer system validation is particularly important in regulated industries such as pharmaceuticals, medical technology and biotechnology. Why is this the case? In these industries, computer systems used to manage critical data must be validated for compliance, quality and system security.
- Compliance: Comply with regulations and standards such as ISO 13485, FDA 21 CFR Part 11, GAMP 5, etc.
- Security: Ensure data protection and data security.
- Quality assurance: Deliver error-free and reliable results.
Fulfil functional requirements safely and reliably
By implementing Computer System Validation, you not only ensure that you comply with national and international guidelines, but also that you:
- have implemented reliable and secure processes,
- receive comprehensive, documented proof that your computer system reliably and completely fulfils the desired functional requirements, after having rectified any deviations identified in the validation.
Avoid software errors with an impact on human health:
As a result, software errors that may have an impact on human health and safety are avoided.
Identification and analysis of the requirements for your system. Conception of a suitable software validation strategy.
Assessing potential risks and implementing appropriate controls.
The use of risk assessments early in the software lifecycle helps to focus validation efforts on critical systems in terms of patient safety, product quality or data integrity and reduce the validation effort.
Creation of a customised validation plan in accordance with e.g. ISO 13485, which takes your specific needs into account.
When carrying out the validation, the intended purpose of the software plays a major role and defines the scope of the validation. The software category and the risk assessment also determine the validation effort and the functions that need to be validated in particular.
Execution of functional tests and verification of system functionalities, including test specification. The aim of the test specification is to create a basis for reproducible tests.
Creation of all necessary validation documents, such as validation plans, test reports, deviation reports.
After validation, a validation report is created and the results of the validation are documented. If the validation is successful, the software can be released.
Once the software has been released, it must be observed in operation and deviations must be recorded and analysed.
Advantages of computer system validation for your company
Computer system validation offers five key benefits for your organisation.
- Optimisation of data security:
Protection against data loss and unauthorised access. - Compliance security:
Adherence to all relevant regulations. - Reduction of risks:
Minimising errors and risks in the operation of computer systems. - Future-proofing:
Ensured functionality of systems during future audits or inspections. - Audit security:
Validation documents that comprehensively demonstrate the validation status of your computer system during audits and inspections.
Definition of computer system validation
Computer system validation is the systematic verification that a computer system works reliably and securely and that it continuously fulfils the required functions in accordance with official regulations (e.g. GMP, GxP). The aim is to ensure the quality and integrity of data that is generated, processed or stored by electronic systems.
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