Client
A leading OTC manufacturer
Industry
Life science
Business goal
Ensure compliance with GMP standards in a pharmaceutical factory through proper management of deviations, customer complaints, and internal audits.
How we helped
- Prepared a business analysis.
- Prepared a functional specification of the solution.
- Developed the solution.
- Tested the solution internally and conducted an acceptance test with the client.
- Deployed the solution in the cloud using MS Azure.
- Prepared instructions and trained users.
- Prepared validation documentation according to GMP requirements.
Business outcome
- Ensured quality: all deviations from product standards are carefully tracked and handled to prevent more serious quality issues.
- Quality monitored: internal audits make it possible to detect problems and take appropriate corrective actions.
- Ensured GMP standards are met: the system monitors compliance with good manufacturing practices in the pharmaceutical factory.