Ensuring Data Reliability with Data Integrity
When data is unreliable, it becomes impossible to make data-driven decisions. Our team will help you define a data integrity policy and build a GAP assessment for your data.
We’ll work closely to define source data for every system, ensuring that your data meets regulatory expectations and supports your IP.
| Data Integrity | Early Stage | Pre-clinical | Clinical | Registration | Market |
|---|---|---|---|---|---|
| Gap Assessment Perform an extensive gap assessment of the various computerized systems, with focus on data integrity capabilities |  | | | | |
| Procedures Establishing data integrity procedures, to ensure implementation of data integrity principals | | | | | |
| Data Solutions Specializing in finding simple and effective solutions, that are tailored to the client’s need, according to the stage of development Perform data integrity audits | | | | |
Data Integrity Audits to Safeguard Compliance
ADRES conducts thorough audits to ensure your data systems are aligned with 21 CFR Part 11, EU Annex 11, and global data integrity frameworks (MHRA, WHO, PIC/S). We focus on:
- Company Adherence to Data Integrity Principles.
- Staff Training & Cultural Awareness.
- Computerized Systems Validation (CSV).
These audits reduce risks related to data manipulation, traceability, or noncompliance, critical for inspections and submissions. Reach out to evaluate and improve your data integrity controls.
