Courses and Conferences on Computer Validation / Software Validation

Nowadays, IT systems are widely used in the pharmaceutical industry. Many technical processes are controlled and monitored by computers. Besides, many more processes couldn‘t actually be performed without IT systems: for example batch releasing in an SAP environment or managing automated warehouses.

In the pharmaceutical industry, such IT systems have to be validated. In Europe, Annex 11 of the EU GMP Guide has defined the requirements for computer validation. The text states: „A computerised system is a set of software and hardware components which together fulfil certain functionalities. The application should be validated; IT infrastructure should be qualified“

Furthermore, section 2 requires that IT developers in the pharmaceutical industry need to have appropriate qualifications. Responsibilities as well as access rights have to be defined. In addition to software suppliers and service providers, each company has to designate experts for the validation of computerised systems. They have to ensure data integrity and product quality through computer validation and risk management measures. The US–American FDA has defined additional and very extensive provisions regarding Electronic Signature and Electronic Records which are laid down in Part 11 of the Code of Federal Regulations.

Concept Heidelberg offers specific courses and conferences for the Computer Validation area. The following courses and conferences regularly take place:

  • Computer Validation: Introduction to Risk Management
  • The GAMP 5 Approach
  • Computer Validation Master Class
  • SAP Validation
  • Maintaining control of Operation for Computerized Systems

Read more here about the Computer Validation Manager Certification Programme.