Pharmaceutical manufacturing requires compliance with GxP (Good Manufacturing/Laboratory/Clinical Practices) regulations. Software systems managing drug batches, recipe parameters, and clinical trial records must be validated to ensure data integrity.
We help pharmaceutical companies validate software systems in compliance with FDA 21 CFR Part 11 and EU Annex 11. We set up cryptographic signatures, immutable audit logs, and version control procedures.
"Data integrity and audit trails are critical for GxP validation in pharmaceutical systems."
This enables companies to transition from legacy setups to modern systems while maintaining compliance with international validation standards.