Computer system validation simply explained

Computer system validation plays an important role for the pharmaceutical and medical technology sectors as GxP-regulated industries. It ensures that computerized systems function properly in production, research and quality assurance. This includes, for example:
Pharmaceutical and medical device companies must ensure that drugs and medical devices are safe and have the desired effect. Software validation ensures that software used in the manufacture, analysis and documentation of products functions correctly.

Medical devices and pharmaceuticals are sensitive, strictly regulated industries. Computer system validation helps companies in these sectors to reliably meet the strict requirements.

By checking correct processes, computer system validation prevents serious consequences such as production downtime, regulatory penalties or false effects.

21 CFR Part 11

The regulation 21 CFR Part 11 is defined by the Food and Drug Administration, FDA, and specifies the requirements that apply to electronic records and electronic signatures. This includes computer system validation, as it is responsible for the creation, processing and storage of electronic records.

EU GMP guidelines

The EU GMP guideline defines standards according to which medicinal products are manufactured in the European Union. Annex 11 of the guideline defines the requirements for computer system validation.

ISO 13485

ISO 13485 defines the requirements that a quality management system for the production of medical devices and pharmaceuticals must fulfill. This also includes computer system validation.

ISO 27001

ISO/IEC 27001 specifies requirements for information security systems. It is important for data security in computer systems.

The main objectives of computer system validation are:

1. To meet the regulatory requirements of the pharmaceutical and medical technology industry.
2. Ensure product safety and quality.
3. Ensure data integrity and data security in the computer system.
4. Identify and minimize risks to avoid malfunctions.
5. Ensure operational safety to avoid production interruptions and downtime.
6. Document validation activities to ensure traceability.
7. Strengthen confidence in the performance and reliability of computerized systems.

Qualification provides documented proof that systems, production facilities and premises are suitable for fulfilling the defined purpose.

Process validation, on the other hand, is responsible for proving that processes and procedures are suitable for this purpose. It is therefore a process validation.

Comprehensive risk management plays an essential role in computer system validation. It identifies and assesses potential risks that may affect patient safety and product quality via computerized systems. By identifying and mitigating risks, an acceptable level of risk is established.

Risk management generally involves the following steps:

1. Identify risks
2. Evaluate and classify risks
3. Develop strategies to minimize risks
4. Integrate risk management into the test phase
5. Document risks and measures
6. Monitoring the current status and updating the measures

The life cycle approach assumes that computer system validation is a continuous process that extends over the entire life cycle of a computer system. It consists of the following phases:

1. Planning and specification
   In the planning and specification phase, the system requirements are defined and the validation plan is drawn up.
2. Implementation
   In the implementation phase, the intended system is installed and configured.
3. Testing
   In the test phase, the implemented solution is put to the test and perfected.
4. Process validation
   Now the computer system validation measures are carried out until successful completion and go-live.
5. Maintenance
   Once the system is in use, it is regularly checked and maintained.
6. Decommissioning
   In the final phase of the life cycle approach, the system is decommissioned in a safe and orderly manner. This can also include archiving the data or migrating to a new system.

Computer system validation is complex and presents numerous challenges. Some examples are:

• The systems are very complex and include various interfaces and databases.
• Technologies are developing rapidly, so the requirements for computer system validation are constantly changing. This requires a great deal of flexibility.
• Computer system validation can be time-consuming and expensive.
• The administrative burden of documentation and careful organization of records takes up resources.
• Change control measures require the utmost care.
• Data security and data protection must be taken into account in all steps and checks.

More on the challenges and stumbling blocks in the process validation of computer systems

To meet these challenges, companies are turning to best practices, such as

• Risk-based approaches that focus on the critical aspects of the system.
• comprehensive validation documentation that includes validation plans, protocols, test reports, proofs of change, etc,
• comprehensive change control that safely guides through adaptations,
• staff training so that people involved know the procedures and guidelines for dealing with computer system validation.

Yaveon covers all these areas with validation consulting. Experience and know-how accompany customers through the entire process of computer system validation right up to the secure system. In doing so, we rely on the principles of the proven V-model. Our solutions are also developed in accordance with GAMP 5.