From day one,
agile compliance
that empowers
your team!
Information Technology infrastructure qualification
The Information technology infrastructure qualification is an assurance that a Computerized System is validated in regulated companies. One time in compliance with the regulatory system, the validate status is supported for standard documents and activities that involve the Quality Assurance
Furthermore, ensure the validate status of a Computerized System minimize the time and costs needed to validate an application, ensure a high level of data integrity in GxP data manipulation and insert good practices in I.T., ensuring performance in accordance with international rules of a trusted network.
Infrastructure Qualification by GAMP5®
The advantages of GAMP5® methodology
The GAMP5® used as a methodology in infrastructure qualification gives advantages as standard documentation, minimum or no one duplicate information documentation and qualification activities.
The infrastructure qualification involves steps from planning to final reports, including Qualification Planning and Performance Qualification.
Planning
Definition of actions to qualify the IT infrastructure.
The planning step involves a general vision and project details, to identify the responsibility for each I.T. professional and the documents that will be created to prove the validated infrastructure status.
At this moment is defined an approach strategy by risks, including management and occurrences mitigation that results in high and medium level, and which are the orientations of regulating authorities for this qualification type. The planning step also includes tests and future procedures.
I.Q., O.Q. and P.Q. steps
Time to qualify the Installation, Operation, and Performance.
The Install, Operation and Qualification steps of I.T. Infrastructure start from hardware compounds specifications to possible occurrences that could appear, taking a view of infrastructure working.
Cloud I.T. Infrastructure
Infrastructure qualification for Cloud Computing based systems
An I.T. virtual infrastructure in regulated companies, for critical applications use needs to qualify. After setting up risks scenarios the work goes ahead with an analysis of availability, security and data integrity.
The supplier analysis helps assure procedures like backups and database disaster recovery. Besides that, there are certifications that assure the quality and infrastructure capacity to replicate energy and supply process, data security and service quality.
Equipment and Utilities Qualification
Computerized Systems Validation
Data Integrity
VLMS - Validation Lifecycle Management System
GAMP5® is a guide that has its intellectual rights reserved by ISPE™. Available for purchase at ispe.org