Data Integrity and Remediation
Validation gaps and data breaches are among the most serious threats pharmaceutical laboratories and manufacturers can face.
Innovation begins with reliable data.
That’s why ANSA is committed to owning our clients’ data integrity — and solving problems before they start.
The future is built on database integrity.
ANSA is a proud leader in data integrity consultation and implementation.
Our methodical approach is designed to work with your company’s existing compliance program or create compliant processes from the ground up. We assess legacy systems, currently-validated enterprise software systems, laboratory software, and manufacturing equipment applications with the goal of uncovering gaps within your program or system validation and remediating them without delay.
Support for Laboratories
ANSA partners with GMP/GLP (Good Manufacturing/Laboratory Practice) facilities to ensure their methods yield reliable, replicable results.
We provide Data Integrity Assessments, including:
- System Security Verification
- Electronic Record Protection Verification
- System Procedures
- Corporate Procedures
- Metadata Protection Verification
- Backup and Recovery
- User Profile Verification
- Identifying Gaps and Outdated Validation Processes
Our Data Support Services also include:
- Data Management Security Solutions and Remediation
- Data Workflow Remediation and IT Structure Organization
- Evaluation of Backup Systems and Applications
- Migration from Paper Records to Electronic Records
- Data Migration Verification
Our expertise in Data Integrity Remediation includes:
- 21 CFR Part 11 Regulatory Requirements
- System Data Integrity Assessments
- Evaluation of Site Processes
- Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) and ALCOA+ Data Integrity Framework
- Electronic Records and Electronic Signatures
- EU Annex 11 European Regulations
- Corrective and Preventive Actions (CAPA)
- Quality Control Process Evaluation
- Re-qualification of Instrumentation
- Periodic System Review
- Audit Trails
Database Integrity for a Rapidly Changing World
Identifying potential gaps and staying in compliance is a full-time job.
ANSA’s expertise keeps us up to date on the most current 21 The Code of Federal Regulations (CFR) Part 11, European Union (EU) Annex 11, and the contemporary requirements of all other relevant regulatory agencies. We stay laser-focused on your database integrity so you can get back to business.