Digital systems are now critical to GMP operations, making data integrity and compliance essential throughout the facility lifecycle. At Gonvert, we help organizations establish robust digital compliance frameworks that ensure electronic records, computerized systems, and automated processes meet regulatory expectations while supporting operational efficiency.

Our experts apply industry best practices, including ALCOA+ principles, GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11 requirements, to create sustainable compliance strategies. From system selection and implementation to validation, governance, and ongoing lifecycle management, we ensure that data remains accurate, complete, secure, and readily available for inspection.

Working closely with Quality, IT, Engineering, Automation, and Operations teams, we integrate compliance into digital transformation initiatives without creating unnecessary administrative burden.

The result is a compliant digital environment that strengthens data reliability, improves audit readiness, reduces regulatory risk, and supports confident decision-making.

Key Areas of Data Integrity & Digital Compliance Expertise:

  • Data Integrity Assessments – evaluating compliance against ALCOA+ principles and regulatory expectations
  • Annex 11 & 21 CFR Part 11 Compliance – ensuring computerized systems meet global requirements
  • Computerized System Validation (CSV) – risk-based validation aligned with GAMP 5 methodologies
  • Audit Trail Review & Management – establishing effective monitoring and investigation processes
  • Electronic Records & Electronic Signatures – implementing compliant digital workflows
  • Access Control & User Management – strengthening security, accountability, and traceability
  • Data Governance & Lifecycle Management – maintaining data quality throughout system operation
  • Digital Inspection Readiness – preparing systems, documentation, and personnel for regulatory audits
  • Change Control & Periodic Review – sustaining compliance throughout the system lifecycle
  • Quality Risk Management for Digital Systems – focusing controls on critical GMP-impacting functions