System validation & data integrity for regulated production environments

With our Data Integrity services, we ensure that your systems not only function correctly but also meet the highest regulatory requirements. From validation documentation to risk management, we provide clarity, security, and reliability in your data and operational processes.

System validation & data integrity for regulated production environments

With our Data Integrity services, we ensure that your systems not only function correctly but also meet the highest regulatory requirements. From validation documentation to risk management, we provide clarity, security, and reliability in your data and operational processes.

System validation & data integrity for regulated production environments

With our Data Integrity services, we ensure that your systems not only function correctly but also meet the highest regulatory requirements. From validation documentation to risk management, we provide clarity, security, and reliability in your data and operational processes.

Ensure audit-proof compliance

Structured, traceable documentation simplifies audits

Avoid Errors

Prevent unexpected system failures and data loss

Control Risks

Reduce dependency on external resources

Ensure audit-proof compliance

Structured, traceable documentation simplifies audits

Avoid errors

Prevent unexpected system failures and data loss

Control risks

Reduce dependency on external resources

Ensure audit-proof compliance

Structured, traceable documentation simplifies audits

Avoid Errors

Prevent unexpected system failures and data loss

Control Risks

Reduce dependency on external resources

Structured, auditable documents for full compliance and clear evidence

Validation documentation in accordance with GAMP 5 & 21 CFR Part 11

Creating validation documentation is time-consuming but essential. Incomplete or unstructured documents can lead to questions, delays in audits, and potentially even non-compliance.


We create precise and structured validation documentation that includes all relevant information about your systems and processes. Our documents comply with regulatory standards like GAMP 5 and 21 CFR Part 11, ensuring that they meet all audit and inspection requirements seamlessly.

Structured, auditable documents for full compliance and clear evidence

Validation documentation in accordance with GAMP 5 & 21 CFR Part 11

Creating validation documentation is time-consuming but essential. Incomplete or unstructured documents can lead to questions, delays in audits, and potentially even non-compliance.


We create precise and structured validation documentation that includes all relevant information about your systems and processes. Our documents comply with regulatory standards like GAMP 5 and 21 CFR Part 11, ensuring that they meet all audit and inspection requirements seamlessly.

Error-free audit documentation

Precise documentation minimizes questions and reduces audit duration

Fulfil regulatory requirements

Quick creation and easy traceability

Efficient document workflow

Standardized templates simplify creation and review

Time and cost savings

More efficient documentation processes save valuable resources

Validation documentation in accordance with GAMP 5 & 21 CFR Part 11

Structured, auditable documents for full compliance and clear evidence

Creating validation documentation is time-consuming but essential. Incomplete or unstructured documents can lead to questions, delays in audits, and potentially even non-compliance.


We create precise and structured validation documentation that includes all relevant information about your systems and processes. Our documents comply with regulatory standards like GAMP 5 and 21 CFR Part 11, ensuring that they meet all audit and inspection requirements seamlessly.

Error-free audit documentation

Precise documentation minimizes questions and reduces audit duration

Fulfil regulatory requirements

Quick creation and easy traceability

Efficient document workflow

Standardized templates simplify creation and review

Time and cost savings

More efficient documentation processes save valuable resources

Risk management & vulnerability analysis for IT & production systems

Systematic evaluation, targeted validation - for audit-proof and stable processes

In production and IT systems, unrecognized risks can lead to serious issues—from unexpected system failures to severe compliance breaches.


We conduct detailed risk analyses to identify vulnerabilities in processes and systems early on. Based on the results, we develop clear, actionable measures that minimize risks and ensure long-term compliance with regulatory requirements.


Our approach helps you avoid potential data loss, enhance operational safety, and make your processes more resilient to both external and internal disruptions. This creates a solid foundation for stable, future-proof operations.

Early risk detection

Vulnerabilities are identified and analyzed early before they can have critical impacts

Targeted risk minimisation

Tailored measures safeguard processes and minimize vulnerabilities

Increase long-term compliance

Rely on real-time information that improves your decision-making

More stable operating processes

Risks are controlled, preventing system failures and production stoppages

GxP training & compliance consulting for validated systems

Rule-compliant practical knowledge for secure processes and competent teams

Compliance with regulatory requirements and the safe handling of validated systems require specialized expertise.


Our hands-on training and individual consulting provide your team with the knowledge necessary to navigate these challenges with confidence. We demonstrate how to efficiently implement regulatory requirements and avoid common errors when working with systems.


This not only strengthens your company's internal capabilities but also helps increase the safety and reliability of your processes in the long term. Trained teams work more efficiently and ensure continuous compliance with all relevant standards.

Imparting practice-orientated knowledge

Teams learn how to implement regulatory requirements efficiently and safely

Reduce errors

Trained employees minimize user errors and enhance process stability

Rapid implementation of compliance

Acquired knowledge is directly applied in daily operations

Building long-term expertise

Your employees are well-prepared for future challenges

CSV & software validation in accordance with GAMP 5 and 21 CFR Part 11

Reliable function, verified compliance - validated systems for secure processes

Software applications and computer systems are the backbone of many business processes—and any instability can have serious consequences.


We test and validate your software applications and computer systems to ensure they function reliably and meet all regulatory requirements. Our validation processes cover all steps, from detailed analysis and extensive testing to final documentation.


The goal is to minimize potential errors, ensure data integrity, and maintain the stability of your systems. This lays the foundation for smooth operations and a future-proof IT landscape.

Stable system performance

Validated systems minimize downtime and ensure smooth operations

Ensure data integrity

Protection and reliability of sensitive data across all systems

Regulatory compliance

Systems are validated and tested according to GAMP 5 and 21 CFR Part 11

Adaptation to requirements

Validation processes are customized to fit your systems and workflows

Systematic evaluation, targeted validation - for audit-proof and stable processes

Risk management & vulnerability analysis for IT & production systems

In production and IT systems, unrecognized risks can lead to serious issues—from unexpected system failures to severe compliance breaches.


We conduct detailed risk analyses to identify vulnerabilities in processes and systems early on. Based on the results, we develop clear, actionable measures that minimize risks and ensure long-term compliance with regulatory requirements.


Our approach helps you avoid potential data loss, enhance operational safety, and make your processes more resilient to both external and internal disruptions. This creates a solid foundation for stable, future-proof operations.

Early risk detection

Vulnerabilities are identified and analyzed early before they can have critical impacts

Targeted risk minimisation

Tailored measures safeguard processes and minimize vulnerabilities

Langfristige Compliance steigern

Rely on real-time information that improves your decision-making

More stable operating processes

Risks are controlled, preventing system failures and production stoppages

Rule-compliant practical knowledge for secure processes and competent teams

GxP training & compliance consulting for validated systems

Compliance with regulatory requirements and the safe handling of validated systems require specialized expertise.


Our hands-on training and individual consulting provide your team with the knowledge necessary to navigate these challenges with confidence. We demonstrate how to efficiently implement regulatory requirements and avoid common errors when working with systems.


This not only strengthens your company's internal capabilities but also helps increase the safety and reliability of your processes in the long term. Trained teams work more efficiently and ensure continuous compliance with all relevant standards.

Imparting practice-orientated knowledge

Teams learn how to implement regulatory requirements efficiently and safely

Reduce errors

Trained employees minimize user errors and enhance process stability

Rapid implementation of compliance

Acquired knowledge is directly applied in daily operations

Building long-term expertise

Your employees are well-prepared for future challenges

Reliable function, verified compliance - validated systems for secure processes

CSV & software validation in accordance with GAMP 5 and 21 CFR Part 11

Software applications and computer systems are the backbone of many business processes—and any instability can have serious consequences.


We test and validate your software applications and computer systems to ensure they function reliably and meet all regulatory requirements. Our validation processes cover all steps, from detailed analysis and extensive testing to final documentation.


The goal is to minimize potential errors, ensure data integrity, and maintain the stability of your systems. This lays the foundation for smooth operations and a future-proof IT landscape.

Stable system performance

Validated systems minimize downtime and ensure smooth operations

Ensure data integrity

Protection and reliability of sensitive data across all systems

Regulatory compliance

Systems are validated and tested according to GAMP 5 and 21 CFR Part 11

Adaptation to requirements

Validation processes are customized to fit your systems and workflows

Precise documentation minimizes questions and reduces audit duration

Quick creation and easy traceability

Standardized templates simplify creation and review

More efficient documentation processes save valuable resources

Systematic evaluation, targeted validation - for audit-proof and stable processes

Risk management & vulnerability analysis for IT & production systems

In production and IT systems, unrecognized risks can lead to serious issues—from unexpected system failures to severe compliance breaches.


We conduct detailed risk analyses to identify vulnerabilities in processes and systems early on. Based on the results, we develop clear, actionable measures that minimize risks and ensure long-term compliance with regulatory requirements.


Our approach helps you avoid potential data loss, enhance operational safety, and make your processes more resilient to both external and internal disruptions. This creates a solid foundation for stable, future-proof operations.

Vulnerabilities are identified and analyzed early before they can have critical impacts

Tailored measures safeguard processes and minimize vulnerabilities

Rely on real-time information that improves your decision-making

Risks are controlled, preventing system failures and production stoppages

Rule-compliant practical knowledge for secure processes and competent teams

GxP training & compliance consulting for validated systems

Compliance with regulatory requirements and the safe handling of validated systems require specialized expertise.


Our hands-on training and individual consulting provide your team with the knowledge necessary to navigate these challenges with confidence. We demonstrate how to efficiently implement regulatory requirements and avoid common errors when working with systems.


This not only strengthens your company's internal capabilities but also helps increase the safety and reliability of your processes in the long term. Trained teams work more efficiently and ensure continuous compliance with all relevant standards.

Teams learn how to implement regulatory requirements efficiently and safely

Trained employees minimize user errors and enhance process stability

Acquired knowledge is directly applied in daily operations

Your employees are well-prepared for future challenges

Reliable function, verified compliance - validated systems for secure processes

CSV & software validation in accordance with GAMP 5 and 21 CFR Part 11

Software applications and computer systems are the backbone of many business processes—and any instability can have serious consequences.


We test and validate your software applications and computer systems to ensure they function reliably and meet all regulatory requirements. Our validation processes cover all steps, from detailed analysis and extensive testing to final documentation.


The goal is to minimize potential errors, ensure data integrity, and maintain the stability of your systems. This lays the foundation for smooth operations and a future-proof IT landscape.

Validated systems minimize downtime and ensure smooth operations

Protection and reliability of sensitive data across all systems

Systems are validated and tested according to GAMP 5 and 21 CFR Part 11

Validation processes are customized to fit your systems and workflows

Frequently Asked Questions (FAQs)

Do you have any additional questions about the Data Integrity services we haven’t addressed on this page? Check out our FAQ section for answers to the most common questions about our products and services from the portfolio. Or feel free to contact us directly.

  • Our latest audit showed that our validation documentation is incomplete. How do we avoid this in the future?

    With automated workflows and GAMP 5/21 CFR Part 11-compliant templates, we structure your documentation in a reliable audit-proof manner. Mock audits help identify gaps early, so you’re prepared for the next inspection.

  • We have a legacy system that’s not validated – but an upgrade isn’t possible right now. What should we do?

    We perform a retrospective validation using risk-based methods, without taking the system offline. We reconstruct missing documentation according to compliance standards, ensuring all regulatory requirements are met.

  • Our lab data is not fully traceable. How do we get it under control?

    Through digital logging, audit trails, and WORM storage, we ensure that every data change is fully traceable. Manual entries are minimized, and all raw data is stored immutably.

  • The FDA has flagged our electronic data storage. How do we ensure compliance?

    We validate existing systems for 21 CFR Part 11 and add electronic signatures, access controls, and tamper-proof audit trails to ensure every process change is audit-proof documented.

  • Our production suffers from unplanned downtime due to faulty software updates. How can we prevent this?

    We use a validated testing environment to test software changes before implementation. Change control processes document and evaluate each change, while rollback mechanisms immediately undo faulty updates.

  • How can I detect risks for data integrity violations early?

    Automated checks and AI-powered anomaly analysis identify implausible data patterns. Our risk scoring system evaluates changes and alerts you to potential violations.

  • Our production is growing, but our IT systems aren’t equipped for increased compliance demands. What can we do?

    We ensure that data integrity remains intact across a centralized, scalable compliance infrastructure. Our solutions are hybrid or cloud-based, enabling them to scale with your business.

  • Our employees make repeated errors in data entry. How can we reduce human errors?

    Electronic logs with real-time validation prevent incorrect entries. Automatic plausibility checks immediately detect discrepancies, and hands-on training enhances process safety.

  • We need to track all changes to production data, but our system doesn’t store it in an audit-proof way. What now?

    We integrate audit trails with automatic versioning into your existing system. Every change is audit-proof stored, ensuring data is always traceable.

  • How do we ensure our suppliers and partners comply with our data integrity standards?

    With Supplier Data Integrity Audits, we review external data flows. A central platform for supplier data ensures all compliance requirements are met, while automated checks detect deviations.

Focus on Smart Data

Discover how digital connectivity and intelligent data analytics optimize production processes. Our insights reveal how data-driven decisions enhance efficiency and how tailored software solutions unlock new possibilities.

Focus on Smart Data

Discover how digital connectivity and intelligent data analytics optimize production processes. Our insights reveal how data-driven decisions enhance efficiency and how tailored software solutions unlock new possibilities.

Focus on Smart Data

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In this article, we shed light on how companies can successfully implement paperless processes and the benefits that result.

Curious about more than automation?

A man in a yellow jacket and hard hat is holding a tablet.

Functional Security And Virtual Security: Two Complementary Aspects Of System Security

March 7, 2025
Functional security and virtual security are two important aspects of system security.
A man and a woman are looking at a tablet in a factory.

certeXo: More safety and efficiency through digital work approvals

March 5, 2025
certeXo digitizes the work approval process, serving as an important organizational safety measure for hazardous activities. The new solution enhances safety, transparency, and efficiency, while also saving a lot of paper.

Curious about more than automation?