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Audit

To guarantee the quality of a software, it is an essential requirement to verify that the software vendor works with a certain level of quality, especially in the case of development of customized products. Consequently, the audit  of the provider gives evidence of the methodology used by the supplier, and whether it will allow proper monitoring of the software lifecycle.

 

According to the GAMP Guide, "Regulated companies should consider the formal assessment of their providers of GxP relevant systems and services". See Appendix M2.

 

Another audit service offered by Asfalia is the audit to the customer's computer systems departments to evaluate compliance of its own internal policies.

 

Also, openness to international markets entails audits and inspections by foreign authorities. Asfalia provides audits for evaluation of compliance with the GxP's and American regulations 21 CFR Parts 11, 810, 812 and 820 and preparation of future inspections of these entities.

 

In all these cases, the audit reports are a useful tool for the customer when selecting a supplier, or as part of a plan of corrective actions and improvements. Asfalia collaborates with the client during the planning and management of the incidences detected during the audit, and the corresponding corrective actions and their follow-up.