Expertise.
Data Integrity Assurance.
Optimizing and ensuring data integrity in accordance with regulatory requirements.
In the long term?
Optimize your data processes to maximize efficiency and reliability.
Secure?
Ensure data integrity according to GxP standards and 21 CFR Part 11.
Compliant?
Maximum transparency and auditability thanks to traceable documentation.
Ensure the integrity of your data processes.
Data Integrity Assurance.
Our Data Integrity Assurance service supports you in complying with regulatory requirements and optimizes your data processes for maximum quality.
We review your existing data processes, identify vulnerabilities and implement optimized data integrity protocols to meet 21 CFR Part 11 and GxP standards. Our solutions ensure that your data processes remain auditable and reliable. Through targeted data process optimization, we ensure the consistency and availability of your data in all areas. In addition, we support you in implementing state-of-the-art monitoring tools to react to potential risks at an early stage and ensure compliance with regulatory requirements. Regular training ensures that your team is always up to date with the latest best practices.
Our services include:
- Regulatory Compliance & Data Integrity: Implementation of 21 CFR Part 11 and GxP compliant systems.
- Process optimization & monitoring: Optimization of existing data integrity processes and introduction of monitoring systems.
- Training & qualifications: Qualification of your employees to comply with regulatory requirements.
Our Data Integrity Assurance services.
Our services ensure that your data processes are continuously optimized and meet regulatory standards.
Regulatory compliance & data integrity.
- Implementation of 21 CFR Part 11 and GxP-compliant data integrity systems
- Validation of your computerized systems to ensure data quality
- Documentation and logging for auditability and compliance
Process optimization & monitoring.
- Analysis and optimization of existing data integrity processes
- Introduction of monitoring systems to ensure data consistency
- Continuous monitoring to minimize risk
Training & qualification.
- Training and workshops to ensure data integrity standards
- Qualification of your employees for compliance with regulatory requirements
- Introduction of best practices for data monitoring and quality assurance
Does your data correspond to ALCOA?
- Assess and evaluate risks
- Validate your system
- Avoid observations and enforcement actions
- Prevent impact on business operations
- Ensure that all data is compliant with the latest regulations
- Achieve growth and success
A Attributable
L Legible
C Contemporaneous
O Original
A Accurate
Successful projects in Data Integrity Assurance.
Our Data Integrity Assurance projects show how we support companies in securing their data integrity and meeting regulatory requirements.
Successfully ensuring data integrity in a pharmaceutical company
Optimization of data integrity in a medical technology company
Ensuring data integrity in an international biotech company
Challenge.
A pharmaceutical company had difficulties ensuring the consistency and reliability of its data during clinical trials.Measures.
- Implementation of a data integrity monitoring system for real-time detection of data deviations.
- Conducting regular audits to verify compliance with 21 CFR Part 11.
- Optimization of documentation processes and introduction of a digital data management platform.
Results.
- 40 % reduction of deviations in clinical data.
- Improved efficiency and data consistency in all study phases.
Success.
The company was able to improve the quality of its clinical trials and comply with regulatory requirements worldwide.
Optimize your data integrity before errors occur.
Our Data Integrity Assurance Service Portfolio.
Our Data Integrity Assurance portfolio provides you with comprehensive support in implementing, monitoring and ensuring data integrity in all your processes. Our specialized solutions ensure compliance, data quality and long-term reliability - tailored to the requirements of the life science industry.
Our experts carry out comprehensive validations of your computerized systems to ensure compliance with 21 CFR Part 11 and GxP standards. These validations guarantee that the data in your systems is consistent, unchanged and traceable at all times. You can find out more about the regulatory requirements in the FDA guidelines.
We help you to digitize and automate your data processes through the use of modern technologies. This reduces sources of error, enables continuous monitoring and improves the efficiency of your processes. Potential data problems can be identified and rectified at an early stage.
Our services include the implementation of systems to ensure data integrity in cloud environments. We ensure that your data complies with regulatory requirements even in modern cloud-based IT systems and is available and protected at all times. You can find more information in the ISO 27001 standards.
We work according to the ALCOA principles: Attributable, Legible, Contemporaneous, Original and Accurate. In addition, we extend these principles with ALCOA+, which includes further requirements such as Consistent, Enduring and Available. In this way, we ensure that the integrity of your data is guaranteed throughout its entire life cycle.
Our solutions enable you to proactively monitor your data processes in order to identify and minimize potential risks at an early stage. Automated checks and continuous monitoring ensure that your data quality remains high in the long term and complies with regulatory requirements.
We support you in preparing for audits by ensuring that your data processes and the associated documentation are audit-ready and complete. Our team will accompany you during regulatory inspections and ensure that your data meets the highest regulatory standards. Find out more in the EMA guidelines.
Avoid risks through proactive data monitoring.
Related topics to ensure data integrity.
These supplementary services help you to ensure the integrity and security of your data in all areas:
