ANSA is a proud leader in data integrity consultation and implementation. We take a systematic approach in working with your established company’s compliance program to assess legacy and current validated enterprise software systems, laboratory software, and manufacturing equipment applications. Our goal is to discover integral fundamental gaps within your program or system validation and remediate them without delay. We follow the most up to date current regulatory compliance standards following 21 CFR Part 11 and Annex 11 guidelines.
ANSA Compliance supports laboratories with the following work:
Data integrity assessments include system security verification, electronic record protection verification, electronic signatures, system procedures, corporate procedures, metadata protection verification, backup and recovery, and user profile verification.
Data management security solutions and remediation.
Data workflow remediation, including IT structure organization.
Data Integrity Remediation Expertise – This process includes evaluation of the current state of systems, system data integrity assessments, evaluation of site processes, quality control process evaluation, re-qualification of instrumentation, upgrades if required, system periodic review process.
Evaluation of backup systems and applications.