SERVICE

CSV audit

Use our validation experience to your advantage

Ensuring compliance in GxP areas

Reliably fulfill regulatory requirements for CSV

Due to technological progress, increasingly complex systems are being used in the life science industry, especially in GxP-relevant areas where patient safety, data integrity and product quality are the focus. As these systems are subject to strict regulatory requirements and official controls, the independent implementation of all audit requirements poses major challenges for many companies.

With our CSV audit, you can ensure that your computer systems meet all the necessary regulatory requirements.

Did you already know?

FDA and EMA inspections show that compliance deviations are frequently found in the validation and operation of computerized systems in the pharmaceutical and medical device industries.

Typical findings:

  • Missing audit trails → Data integrity risk

  • Insufficient testing

  • Weak change control processes

  • Gaps in user rights and electronic signatures

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Our services

We plan, implement and document audits in a regulated environment (GMP, GCP, GLP). We distinguish between

IT system audits

GxP-relevant system with aspects of infrastructure, data integrity, security, backup, user rights

CSV Process Audits

Validation framework of computerized systems over the entire life cycle

The audit is based on the EU GMP guidelines Annex 11 and GAMP 5. The audit content is based on the GxP-relevant requirements and includes, among other things
Risk management
Validation of computerized systems (CSV)
Data integrity (ALCOA+)
Audit trail and electronic signatures
Supplier qualification
IT security and backup
Incident management and change control
Archiving and business continuity
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Risk management comprises the identification, analysis, assessment and control of risks. The aim is to identify threats at an early stage, derive effective measures to mitigate them and continuously monitor their effectiveness. This enables organizations to operate securely, efficiently and compliantly.
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The validation of computerized systems (CSV) is the documented proof that an IT system reliably and reproducibly fulfills its intended purpose and complies with all relevant regulatory requirements.
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Data integrity (ALCOA+) refers to ensuring that data is recorded, stored and managed completely, consistently, accurately, traceably and reliably throughout its entire lifecycle.
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An audit trail seamlessly records all changes to data, while electronic signatures ensure their authenticity, integrity and accountability.
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The qualification of suppliers ensures that external service providers and suppliers use processes and systems that are suitable for the regulated company. This includes the assessment, documentation and regular review of their suitability.
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Sensitive data and systems must be protected against unauthorized access. In addition, backup strategies must be implemented for recovery in the event of data loss or system failures.
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This structured process is used to record, analyze and rectify incidents and process deviations on the one hand and to implement changes to systems in a controlled manner on the other. This makes it possible to minimize risks to compliance and data integrity.
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This requirement ensures that GxP-relevant data and documents are stored securely in the long term and that measures to maintain critical business processes in the event of emergencies or failures are carefully planned.

Validation and qualification for the highest quality and regulatory compliance

Discover proven methods, guidelines and best practices to ensure that your systems, processes and products meet the highest quality standards. Together we optimize your quality assurance strategies.

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Validation and qualification

Our expertise, your added value

Good reasons for our CSV audit

  When everyone involved - from management to the authorities - trusts the IT system, a common foundation for quality and compliance is created.

Robert Neumann | Management Consultant Life Science

About Robert Neumann
Robert Neumann

Why Syncwork?

We do things differently

During a CSV audit, we put your computer system validation processes and documentation through their paces. This requires expertise and years of experience in the regulated environment. You can rely on our consultants to have an in-depth understanding of IT systems and expertise in validation. They draw on proven procedures and specific templates for the audit.

In addition, our audit includes meaningful recommendations for action. This allows you to take the next steps immediately and minimize risks. The modular structure of the audit makes the process flexible and scalable, which is why it is also suitable for SMEs that want to gradually achieve transparency, compliance and efficiency. This gives you a practical, comprehensible audit with actionable results.

Contact us today to find out more about our customized audit offering.

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Robert Neumann

Franklinstraße 26a
10587 Berlin

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