Estrategias de cumplimiento y preparación de inspecciones

The pharmaceutical and fine chemicals industry delegates the control of most of the processes to a number of computerised systems. As a consequence, these systems have become critical components for ensuring compliance of GxP regulations.

Health Authorities worldwide have significantly increased the pressure over them and their hosted data. As a recent example, the expectations on Data Integrity for electronic data have experienced a dramatic increase with respect to the procedures and requirements applied in the last ten or 15 years since the latest guidances on the application of 21CFR part 11 or the latest version of EU GMP Annex 11.This higher pressure produced  a significant increase of the amount of observations in regulatory inspections, related to computerised systems, with special relevance in the topics related with data integrity.  These observations may result in serious problems with Health Authorities, with severe consequences for the company financial results and public reputation.

In this situation, the regulated industry is being forced to increase the technical and regulatory approach of their computerised systems validation and management practices, as otherwise they may not fulfil the expectations of current inspections

TDV is a worldwide known consultancy company who has been recognized as a leading actor in computerised systems validation. TDV always performs these activities with a high technical and quality level, conscious of the regulations and current practices in the pharmaceutical industry and permanently considering the real needs of the customers. These values have allowed generating state-of-the-art documentation, fulfilling the requirements of the inspectors of worldwide Health Authorities and multiple customer circumstances.

In order to achieve the aforementioned quality level, TDV has a workforce formed by international consultants that have extensive knowledge of all the common types and brands of computerised systems commonly used in the pharmaceutical industry. TDV, sensible to the flexibility required by their customers, adopts in each case the role that better fits with the specific need of the customer: from full involvement projects where a minimum customer effort is required to a consultancy role for the key project activities, allowing an accurate budget.

But the experience of TDV goes beyond the validation of computerised systems. TDV is also able to provide the following key services for the regulated industry:

  • Data Integrity assessment and action plans
  • Decommissioning of computerized systems
  • Quality Management System for IT departments
  • Quality Management System for software developers
  • Qualification of IT infrastructure

For further information about Computer System Validation, please contact:

Sergi Arcas
sarcas@tdvct.com