COMPUTERIZED SYSTEM VALIDATION

Product description

Since 2000 Adeodata is specialized in the computerized systems of the pharmaceutical industry: from validation to Data Integrity assessment and remediation of systems in the range from simple PLCs on board of production equipment or laboratory equipment, up to more complex systems, such as management systems (ERP, MES LIMS, document management systems ...). Doing this, it is necessary to analyze the organizational processes (the context in which the system is used) and to identify critical functions for GxP purposes, in order to focus the validation activities making the effort sustainable.
The inspectors' requests evolve according to new regulations or guidelines (as for Data Integrity) and the validation documentation must be constantly updated.

OUR COMPETENCE AND EXPERIENCE

Right here Adeodata makes the difference. In fact, the experience, the continuous updating and the competence of our consultants guarantee an approach that is always in line with the regulatory requirements. This is why Adeodata has put these factors at the center of its quality system and invests 5% of its turnover in:
  • studying of the regulations (and related updates) by the dedicated staff (Subject Matter Expert - SME) which participates in the national and international work groups that issue and maintain the guidelines (these include the Good Practice Guides of GAMP and ISPE);
  • updating the internal standards, also for the new systems that have been validated;
  • training of all its consultants on these standards (on average from 5 to 15 days / year of training and support, respectively for senior consultants and new hires).
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COMPUTERIZED SYSTEM VALIDATION

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