Switzerland +41 91 980 33 18 - info@adeodata.eu / Italy +39 02 967 209 33 - info@adeodata.eu Company Consultancy Product Careers TRAINING The fruitful collaboration with Quality Systems, a company that deals with training and consulting for the pharmaceutical sector, has allowed us to provide, among other services, GxP training in the form of in-house courses and seminars related to: quality system, medical device , logistics, production, microbiological QC laboratory, Auditor... We are convinced that specialist training and staff training are a decisive factor for the competitiveness and growth of any company. ALL QUALITY SYSTEMS SERVICES GxP workshops In-house courses (Quality Systems is able to assist you in the process of obtaining funding from inter-professional funds). Consultancy Quality Systems has developed a series of services dedicated to GMP compliance to support companies in solving the most complex problems, such as: GMP risk assessment Reorganization of the Quality System processes Drafting and revision of documentation and reports, SOP, VMP, PQR/PAR Due diligence Outside resourcing Cleaning validation Documentation translation Drafting of registration dossiers in CTD format Drafting of technical dossiers for MD Audit/Mock Inspections (in preparation for authority inspections) Stay tuned! Follow us on Linkedin I authorize the processing of my personal data Adeodata S.r.l. Via E. Mattei, 2 — 22070 Bregnano (CO) Registered office: Via Carducci, 32 — 20123 Milano VAT Nr. 05617310965 REA 1834791 Milano PEC adeodata@pec.it Adeodata SA Via Calgari, 2 — CH 6900 Lugano IDI CHE-112.203.579 Cookies policy | Privacy policy © 2019 Adeodata. All rights reserved. Designed and developed by Carrara Communication

Switzerland +41 91 980 33 18 - info@adeodata.eu / Italy +39 02 967 209 33 - info@adeodata.eu Company Consultancy Product Careers IT COMPLIANCE FOR CLINICAL TRIALS AND CROS Monday 25 January 2021 In recent years, more and more companies have requested compliance assessments and validation of computerized systems used in clinical trials. Requests have increased especially following the "Notice to sponsors on validation and qualification of computerized systems used in clinical trial" issued by the EMA on 7 April 2020. Since 2008 we have been providing IT compliance support to clinical departments of pharmaceutical companies and directly to CROs. Here you can find the projects we have successfully conducted in the GCP field, as well as the regulatory references and guidelines on which we rely to set up the activities. Ask for a consultancy < Back Stay tuned! Follow us on Linkedin I authorize the processing of my personal data Adeodata S.r.l. Via E. Mattei, 2 — 22070 Bregnano (CO) Registered office: Via Carducci, 32 — 20123 Milano VAT Nr. 05617310965 REA 1834791 Milano PEC adeodata@pec.it Adeodata SA Via Calgari, 2 — CH 6900 Lugano IDI CHE-112.203.579 Cookies policy | Privacy policy © 2019 Adeodata. All rights reserved. Designed and developed by Carrara Communication