Solutions.
Data Integrity Assurance.
Secure your data processes and ensure compliance with international standards.
Long term.
Optimize your data processes to maximize efficiency and reliability.
Secure.
Ensuring data integrity in accordance with GxP standards and 21 CFR Part 11.
Conform.
Traceable documentation and monitoring for maximum transparency and auditability.
Secure your data integrity and ensure compliance.
Optimization of your data integrity processes for compliance and quality.
Our services help you to meet regulatory requirements and ensure the quality of your data processes.
Our services include reviewing your existing data processes, identifying potential vulnerabilities and implementing optimized data integrity protocols. We support you in implementing 21 CFR Part 11 and GxP standards to ensure compliance with international regulations. With our audits and risk analyses, you can ensure that your data is consistent, reliable and available at all times. Our approach enables you to standardize processes and ensure data integrity in all areas of your organization. In addition, we provide training and qualification for your employees to ensure that data integrity best practices are implemented on a permanent basis.
Our Data Integrity Assurance services.
We offer customized solutions to ensure data integrity in all your company's processes.
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
Case Studies.
Our case studies in Data Integrity Assurance for Life Sciences.
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.
An international biotechnology company faced the challenge of harmonizing data integrity across multiple sites to meet the requirements of global markets.
Measures.
- Implementation of a global data integrity audit
- Development and implementation of a standardized data integrity system.
- SKontinuous training to ensure compliance with regulatory requirements
Results.
- 40% faster data validation processes
- Harmonization of data management systems at all production sites
- Improving data consistency and auditability in several international markets
Success.
The company was able to harmonize its data management systems globally and ensure regulatory compliance.
Optimize your data processes and ensure compliance with the highest regulatory standards.
Data Integrity Assurance - Tailor-made solutions for your data processes.
Our service portfolio supports you in implementing, monitoring and ensuring data integrity in all your processes.
- Implementation of data integrity systems in accordance with 21 CFR Part 11 and GxP
- Audit preparation and ensuring data compliance
- Process monitoring and continuous data integrity check
- Training your employees to comply with regulatory requirements
- Optimization of data processes to ensure data consistency and availability
Entourage is looking for life science experts.
Become part of our team.
