Pharmaceutical and Medical device companies rely heavily on computer and IT systems to manage their operations. Regulators such as the US FDA, MHRA and TGA require appropriate controls in the management of these systems to ensure that the data generated for making decisions that impact product quality can be trusted.
SeerPharma has deep expertise in auditing and assessing GxP-IT systems and applications, and routinely requested to conduct audits against:
Regulations and Standards
- FDA 21 CFR Part 11
- PIC/S Annex 11
- ISO 62304 – Software Lifecycle development
- ISO 90003
Contact us to learn more about our GxP-IT auditing services, or click the below button to learn about our range of GxP auditing services.
