Expertise.
21 CFR Part 11 and data integrity.
Implement reliable e-records and signatures for maximum data integrity in the pharmaceutical and biotechnology environment.
Secure?
Are electronic records and signatures reliably protected and protected against manipulation?
Compliant?
Do your processes meet all FDA requirements in accordance with 21 CFR Part 11 for the use of digital systems?
Fit for the future?
Are your validation and documentation methods already adapted to the latest regulatory requirements?
21 CFR Part 11 and data integrity.
Electronic records & FDA requirements.
Compliance with 21 CFR Part 11 is essential for pharmaceutical and biotechnology companies to validate electronic records and electronic signatures. We support you in ensuring the integrity of your data, preventing tampering and reliably fulfilling FDA requirements.
Our services include system validation to implement and validate e-records and e-signature systems in accordance with FDA requirements to prevent data manipulation. We carry out risk assessments and GAP analyses to identify potential weaknesses in existing processes and initiate targeted improvement measures.
We also offer support in the area of data integrity and compliance by setting up a structured quality management system that complies with all data integrity and recording requirements. We support internal and external audits by preparing comprehensive validation and compliance documentation.
Secure your process data with our 21 CFR Part 11 expertise.
21 CFR Part 11 and data integrity - Efficient FDA compliance.
Our solutions ensure that you meet all FDA requirements for electronic records and signatures - from implementation to continuous process optimization.
Validation strategy and documentation.
- Development of a risk-based validation strategy for digital systems.
- Preparation of all necessary validation documents and SOPs.
- Verification of compliance with regulatory requirements.
Electronic signatures and access rights.
- Introduction of clear guidelines for secure e-signatures and access authorizations.
- Definition of responsibilities and control mechanisms.
- Integration into existing IT structures and workflows.
Data integrity and audit trail.
- Introduction of an e-record system in the pharmaceutical industry
- Monitoring and checking of access and change logs.
- Regular assessment of data integrity and derivation of preventive measures.
Practical examples: Successful implementation of 21 CFR Part 11.
Compliance with 21 CFR Part 11 is critical for companies in regulated industries such as pharmaceuticals and biotechnology to ensure the integrity of electronic records and signatures.
Introduction of an implant system
Data integrity in the biotech sector
Software validation for clinical studies
Challenge.
Migration from paper-based records to a digital system while complying with FDA regulations.Measures.
- Implementation of an electronic document management system (EDMS) with validated workflows and access rules.
Results.
- Time savings through automated approval processes and proof of data integrity for FDA audits.
Success.
Successful inspection by the FDA and accelerated market launch of new products.Ensure the compliance of your electronic records.
Our 21 CFR Part 11 service for maximum data integrity.
With our solutions, we guarantee the secure, legally compliant and seamless capture of your electronic data and signatures.
We design and validate your digital systems to ensure that electronic records and signatures meet the requirements of 21 CFR Part 11. In doing so, we ensure the correct proof of all changes and approvals and guarantee the integrity of the recorded data. In addition, we implement secure, computer-generated and time-stamped audit trails that fully document all changes, deletions and modifications.
Through targeted risk assessment and comprehensive GAP analyses, we identify systematic weaknesses in existing processes. We develop strategies to minimize risks and support you in sustainably maximizing data quality. In doing so, we take into account the implementation of access controls and user authorizations to ensure that only authorized persons have access to the systems.
We assist you with internal and external audits, prepare the necessary documentation and ensure sustainable compliance in accordance with 21 CFR Part 11, ensuring complete traceability and documented integrity of all electronic data. We also support you in the introduction and management of electronic signatures to ensure that they are forgery-proof and can be assigned to the relevant persons.
To ensure secure use and compliance with regulations, we offer training for your employees. This includes the use of electronic systems, the correct use of e-signatures and the importance of data integrity. We document the training measures comprehensively to ensure that they can be verified during audits.
Ensure your data integrity and FDA compliance.
Related content: Compliance and data integrity in regulated industries.
To ensure compliance with 21 CFR Part 11, comprehensive approaches to data integrity and system validation are essential.