Is your company in the medical or pharmaceutical sectors? Do you need to evaluate the impact of your computer systems and validate those that impact critical processes?

The medical/pharmaceutical sector is a highly regulated sector with a specific problem: all computer systems must be evaluated and those that impact critical processes, product quality or patient security must be validated.

The objective of validating a computer system is to demonstrate that it has been installed, configured and is being used for the purpose for which it was specifically designed. It is estimated that the cost of validating a computer system represents at least 30% of the system’s time and cost. Any savings or enhancement in the validation process therefore has a high economic impact.

This validation is carried out in accordance with the recommendations of professional sector organizations, such as the GAMP Forum  (currently integrated in the ISPE, International Society for Pharmaceutical Engineering), which publishes a guide to help sector suppliers to build systems that fulfill European and North American regulations and sector companies to define the validation process that they must follow to verify it. (The latest published version of this guide is that of 5 January 2008).

Visure’s IRQA for Medical and Pharmaceutical Sector provides full support to automated system validation activities, in accordance with the GAMP 5 guide.

IRQA for the Medical and Pharmaceutical Sector

IRQA for Medical and Pharmaceutical Sector offers a comprehensive solution for validating automated systems in the medical/pharmaceutical sector.

IRQA for Medical and Pharmaceutical Sector allows you to considerably reduce validation times and costs while improving the quality and control of the deliverables produced during the validation process. It also helps to standardize and disseminate good practices within an organization.

IRQA for Medical and Pharmaceutical Sector gives support to:

• Medical/pharmaceutical sector companies which must validate those computer systems that impact critical processes and maintain the validated state thereof.
• Manufacturers of systems or instruments for the medical/pharmaceutical sector which must demonstrate that the system has been developed in accordance with a controlled development process and is suitable for being validated.
• Companies or professionals that offer computer system validation consulting services.

IRQA for Medical and Pharmaceutical Sector solves the following problems:

• IRQA for Medical and Pharmaceutical Sector allows you to comprehensively manage the system validation process by defining requirements, specifications, tests and risks, in addition to the necessary traceability between all of them.
• IRQA for Medical and Pharmaceutical Sector allows you to manage the main concepts managed in a validation project, including:
  
  • User requirements (URS)
  • Functional specifications (FS)
  • Design specifications (DS)
  • Traceability matrix URS-FS and URS-DS
  • Risk factors associated to FS or URS (bottom-up risk analysis)
  • System risk factors (top-down risk analysis)
  • IQ test catalogue
  • OQ test catalogue
  • PQ test catalogue PQ
  • Traceability of OQ/PQ to URS/FS tests.
  • Etc.
• The IRQA for the Medical and Pharmaceutical Sector solution allows you to define templates and automatically generate several of the documents that must be generated during the validation project. In this manner, validation costs and times are considerably reduced and the quality and traceability of changes in the deliverables are increased.
• IRQA for Medical and Pharmaceutical Sector is totally flexible, adapting to the specific validation process of each organization through the definition of a personalized meta-model. For example:
  
  • New requirements categories can easily be defined (functional, non-functional, regulatory), each with its specific attributes.
  • New concepts used in each organization or process can be defined, with their attributes and characteristics.
• The IRQA for the Medical and Pharmaceutical Sector solution supports bottom-up risk analysis, allowing you to define attributes for each system function (FS) or user requirements (URS), in such a manner that the key factors for determining the risk of each function can be identified (e.g.: complexity, impact, detection facility, failure probability, etc.), in addition to the resulting risk factor.
• The IRQA for Medical and Pharmaceutical Sector solution supports top-down risk analysis, allowing you obtain the main risks identified in the system, in addition to the attributes considered relevant and actions for eliminating or mitigating these risks.
• The IRQA for Medical and Pharmaceutical Sector solution allows you to define and manage traceability matrices between any pair of elements managed in the system.
• The system allows you to efficiently and intuitively manage the following matrices:
  
  • URS-FS matrix - Traceability matrix for tracing user requirements to functional specifications.
  • FS-TEST OQ/PQ matrix - Traceability matrix between tests (OQ/PQ) and system functions.
  • URS-TEST OQ/PQ matrix - It is the combination of the preceding matrices and allows you to trace user requirements to the different tests performed during validation (test coverage analysis).
  • Etc.
• The IRQA for Medical and Pharmaceutical Sector solution allows you to import and export requirements from Word and Excel by simply clicking a button, indicating the requirements that have been modified or added.
• The IRQA for Medical and Pharmaceutical Sector solution allows you to manage the traceability and impact analysis of the changes.
• The IRQA for Medical and Pharmaceutical Sector solution allows you to reuse requirements, validation procedures and requirements specification services in different projects using IRQA’s advanced reusable components functionality.

Additionally…

The IRQA for the Medical and Pharmaceutical Sector solution can also be used in the medical/pharmaceutical sector as a Requirements Definition and Management tool for building systems, as the IRQA tool itself fulfils current sector regulations.

In 2009, IRQA 4 successfully passed a validation process based on Standard IEC 62304 (Medical device software – Software lifecycle processes), in an important European medical sector company, where IRQA is being used to manage requirements and traceability with tests.