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COMPUTERIZED SYSTEM VALIDATION


We are 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).

 We don't improvise in this field; some of us have been working on it since 1992. While it is relatively easy to reuse a simple system validation protocol, however:

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

 

Paperless validation
Adeodata has designed and developed its own method of paperless validation of computerized systems. The method does not require special software to manage validation documentation, just a simple tool.
With paperless validation, computerized systems can be validated completely digitally, without the need to manually compile protocols and tests and without the need to print them out on paper for signing and archiving.

 

 

Competence and experience

This is precisely where Adeodata makes the difference: experience, continuous training and expertise of our consultants ensure an approach is always in line with regulatory requirements.
We put these factors at the center, and each year we invest 5% of turnover in:

  • study of regulations and updates by GxP Compliance Experts, who participate in national and international working groups dedicated to issuing and updating guidelines (such as ISPE's GAMPs);
  • updating of internal standards and procedures, including against newly validated systems;
  • training and refresher training for all consultants (5-15 days/year of training for all consultants and 3 months of on-the-job coaching/training for newly hired consultants).

 

Reference regulations

  • Eudralex Vol.4 - EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 11 - Computerized Systems (2011)
  • FDA, 21 CFR Part 11 - Electronic Record & Electronic Signatures (1997) + new official FDA interpretation (2003)
  • ASTM E2500, Standard guidance for specification, design and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment (2013)
  • Data integrity: MHRA guidelines (2015-18), WHO (2016), PIC/S (3rd draft 2018), FDA (2018), GAMP (2016-18)

 

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.
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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