seQure validates regulated systems in a cost-effective, efficient and fully compliant manner for both the GMP, GVP and GCP environment. We are made up of a team of expert consultants who can provide consultative support for maintenance, revision and verification activities regarding the validation status of applications.

To optimize the validation process, seQure applies an approach based on pragmatic risk and efficacy assessment in order to focus on the more critical areas of validation.

seQure’s consultancy approach is related to the maintenance of computer systems with the goal of supporting companies in guaranteeing that systems are maintained in accordance with regulatory requirements, secure and adequate for the needs of end users. This is done through a documented process that ensures a system continuously functions as intended.

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Consultancy for computer system maintenance include:

  • Periodic Compliance Review of computerized systems and IT infrastructure
  • Management, review and approval of change requests (Change Control)
  • Internal Audits
  • Continuous training for end users
  • Remote technical support for issues related to computer system management