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Computerized System Validation (CSV)


We can support you in all the activities concerning the Computerized Systems Life Cycle, in compliance with the relevant guidelines (GAMP,…):

  • Definition of the Process and of the User Requirement Specification (URS)
  • Supplier audit
  • Risk Analysis
  • Evaluation of the supplier development activities: FS, SDS, HDS, SAP BBP
  • Editing and execution of validations protocols (IQ, OQ, PQ)
  • Editing of the Validation Report with potential remedial actions
  • Editing of procedures to maintain the Validation Status: Access Management, Configuration Check, Periodic Tests, Backup and Restore, Disaster Recovery
  • Periodic Review
  • Training (as part of the Computerized Systems  Validation Process)

Adeodata performed several projects of creation and validation of systems such as: ERP, MES, LIMS, EDMS, lab equipments, clinical data management, IT infrastructures, PLC, SCADA, DCS, HVAC, BdMS.

A GMP compliant validation means QUALITY and it’s an opportunity for the Customer to increase and enhance since the staff can analyse, deeply understand and even optimise the company processes.

This results in an added value for the company and the whole production system.

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

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