Implementing solutions requires of partners to walk the road
Born in 2001, Adeodata aims to be a partner in defining methodologies, guidelines, procedures and activities for the Computerized System Validation, following GAMP 5 and PIC/S 011 guidelines.
Adeodata provide consulting services to several Life Science companies of utmost importance in the Italian, Swiss and international market, working in the pharmaceutical, APIs (Active Pharmaceutical Ingredients) and medical devices fields.
Adeodata core business areas are:
- Computerized Systems life cycle: Validation Plan, URS, suppliers audit (for systems and/or services), risk analysis, drafting and execution of test protocols (IQ/OQ/PQ), Validation Report for:
- Production (ERP, MES, SCADA, PLC, maintenance management SW)
- Serialization (Track & Trace – End to End)
- Labs (LIMS, CDMS, HPLC, IT infrastructures, EDMS)
- Clinical research and pharmacovigilance (including clinical databases and Remote Data Capture systems)
- Data Integrity Assurance in compliance with GxP, EU Annex 11, FDA 21CFR part 11, ICH Q7, including Remedial activities and Data Governance
- Plant, utilities, equipment and systems qualification
- Instruments calibration (also using paperless CMS)
- Specialized training
Starting from 2011, we boast an ISO 9001 certified quality management system, upgraded to the new 2015 revision in November 2017.
Adeodata Offices addresses
Operational and administrative site: Via Cavour, 2 – 22074 Lomazzo (CO) c/o ComoNExT S.c.p.A.
Registered office: Via Carducci, 32 – 20123 Milano
Operational site in Parma: Piazzale Arturo Balestrieri, 31A – 43123 Parma
Phone number +39 02 96720933
Via Calgari 2 – 6900 Lugano
Phone number +41 91 9803318