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