During the years, Sisthema has gained a significant experience in the organization and execution of audits in different fields: pharmaceutical (API, finished products, excipients, packaging), medical devices, cosmetic and food.
Using a network of highly qualified auditors, some of which on site, Sisthema is able to perform audits all over the world according to the main regulations and the specific needs of the customer.
Indeed, the customer is involved in the preparation of the audits by completing specific forms to help the auditor to prepare the inspection according to its needs.
Sisthema’s strength is the possibility to perform Shared Audits: audits in which the inspector represents different customers.
This means a double advantage: the suppliers can save time, since they receive fewer inspections at their plants; the customers can save money, since the costs are divided.
Sisthema guarantees its support also in the post-audit activities, by following the customer’s approval of the report, asking to the auditor for an integration, if necessary, and for the evaluation of the CAPA plan proposed by the suppliers in response to the deviations.
Sisthema gives also the possibility to its customers to purchase existing audit reports, upon agreement of the suppliers and the initial customers involved.
Indeed, in case a supplier is not very cooperative, the purchase of an audit report can be a good alternative.
This procedure is widespread, although carefully controlled.
In case of a first contact or if requested by the customer, Sisthema is available to schedule meetings or conference calls to make an even more careful and proactive evaluation of the activities to be done.