COMPUTER SYSTEM VALIDATION & DATA INTEGRITY
We provide compliance to 21CFR Part 11 / EU Annex 11 regulated life science companies IT systems, by providing CSV and Data Integrity services.
Data Integrity and CSV Program Implementation
- Audits, Assessments and Remediations to ensure compliance to EU, US GMP and other regulations, in addition to ALCOA+ principles
CSV Program Implementation
- Implementation of CSV Programs for sites; Site CSV VMP, CSV SOPs/Forms/Templates Development of standardized CSV SOPs for computer validation, network infrastructure, user management and security, administration, ERES and data integrity, disaster recovery, maintenance, change control, vendor management & auditing. Development of standardized validation templates and lifecycle documents including VP, RTM, URS, FS, DS, DQ, IQOPQ, Final reports adhering to current compliance, guidelines and risk-management practices. Provide and implement risk-based tools to guide and focus validation efforts including transition from CSV to CSA.
CSV System Supported
- Lab Informatics (LIMS, Trackwise, Elisa, Empower, LabX, OpenLab, Etc…) Validation of Cloud-Based, COTS, SaaS, PaaS, IaaS, and Custom Applications Examples of Software include: ERP, eQMS, Adverse Event
