Computer System Validation and Data Integrity

What is Data Integrity?

Data Integrity refers to a series of requisites that all kind of data – both paper based and electronic data – must be in compliance with. It stems from the ALCOA+ principles of integrity; in the Pharma environment, a data must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available through its life cycle. Maintaining the integrity of a data over time is a never-ending process involving different formats, rules, and standards.

Computer System Validation and Data Integrity

A tailored made GxP approach

Our team of CSV experts with consolidated experience in any environment, ranging from heavily structured Pharma companies to small biotech subsidiaries who are moving the first steps towards digitalization compliance, can help clients with a custom & tailored made approach to fulfilling GxP regulation and achieve FDA or Eudralex compliance for their Computerized Systems.

Master Data Support

A Data Integrity assessment as starting point

The first step could be to produce a Data Integrity Assessment – its scope and effort custom made for the needs of our clients, in which key factors are challenged, such as:

  • System access and security policies;
  • User group privileges and permissions;
  • Identification of criticality of electronic data;
  • Verification of intended use and business process.

All Computerized Systems can be challenged

We have direct experience with all Computerized Systems that could come into your mind at any time, of any department, of any GAMP Complexity category and anywhere on the ISA-95 pyramid – Production equipment such as filling machines, serialization software, PLC, SCADA, Network Infrastructure elements, high level ERPs, QC instruments like bioreactors, spectrophotometers, centralized balances software, sample management systems and many other.

Multi-disciplinary approach on Data

To provide for a comprehensive assessment, a multi-disciplinary approach is mandatory, embracing all activities on key equipment and interfacing with all users with responsibility towards the system. Our CSV experts will pass through documentation analysis, interviews and on-the-field inspections, getting involved with the IT environment and contextualizing the functionality of the system in its affected process and within the applicable regulatory framework.

KYDEA Group digital solution service

A support in Remediation Implementation

Any gaps identified in the Assessment phase must be acted upon for its remediation; with a vast, multi-faceted experience in the Pharma industry, our consultants can work with the client to find the best – the most sensible and efficient – solutions, which can be:

  • Specific modifications to software configurations;
  • Leverage from services offered by qualified IT Infrastructure;
  • Finding the best alternative module / solution on the market;
  • Planning and execution of CSV decommissioning projects.

A 360 degree support for CSV

The strong know-how matured in all kinds of Pharma companies in which our senior consultant worked on, allows us to provide for a 360 degree support for Computerized System Validation activities, such as:

  • Guiding our clients in defining requirements for systems or equipment and identifying the appropriate validation strategy;
  • Direct the project toward the best solution to satisfy intended use, regulatory requirement – with an eye on budget costs;
  • Plan, define, execute, maintain all CSV activities and deliverables for the implementation of new systems;
  • Direct support for first, second and third party Audits;
  • Get directly involved with the QA department for reviewing or directly drafting SOPs related to the management of Computerized Systems.