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Historically we have specialized in the validation of computerized systems for the pharmaceutical industry, from those on board production and laboratory equipment, to those supporting the management of operations, document flows and all business processes (MES/EBR, EDMS/QMS, ERP).

There is no sudden improvisation in this sector. If, in fact, it is relatively easy to re-use a simple system validation protocol, however:

    • in the case of more complex systems it becomes necessary to analyze the organizational processes, to identify the critical functions for GxP purposes and consequently to limit the validation (in terms of deliverables and tests), making the effort sustainable;
    • inspectors' requests evolve according to the new regulations or guidelines (as happened for Data Integrity) and the validation documentation must be constantly updated.

Excursus of historical reference regulations:

    • 1992: issue of Annex 11 Computerized Systems at European GMPs;
    • 1997: introduction by the FDA of the 21 CFR Part 11 Electronic Record & Electronic Signatures and the new official FDA interpretation of 2003;
    • 2007: issue of ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment reconfirmed in 2013;
    • 2011: issue of the new version of Annex 11 at the European GMPs.
    • from 2014: renewed attention to Data Integrity by the inspectors, in particular for electronic recordings, with the issuance of numerous guidelines including MHRA (2015-18), WHO (2016), PIC / S (3rd draft 2018), FDA (2018), GAMP (2016-18).

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 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:

    • study of regulations (and related updates) by dedicated staff (Subject Matter Expert - SME) which participates in national and international work groups that issue and maintain the guidelines. These include the Good Practice Guides of GAMP and ISPE;
    • updating of internal standards, also in the face of new validated systems;
    • training and updating of all its consultants (on average from 5 to 15 days / year of training for all consultants and about 3 months of coaching / training on the job for new hires).

List of activities in detail:

  • Definition of process flow and requirements (URS)
  • Supplier Audit
  • Drafting of Validation Plans
  • Risk Analysis
  • Evaluation of supplier development activities: FS, SDS, HDS, SAP BBP
  • Drafting and execution of validation protocols (IQ, OQ and PQ)
  • Drafting of the final Validation Report and Matrix of Traceability of the requirements
  • Drafting of procedures for maintaining the validation status: access management, configuration control, periodic checks, data saving and recovery, system unavailability (Disaster Recovery)
  • Periodic Review services
  • Staff training (as part of the computerized systems validation process)
  • System assessment
  • Infrastructure qualification
Adeodata S.r.l.
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