IT Validation Master Planning

IT as such and the underlying complex software are complicated enough on their own, but their use in a GMP-regulated environment is a major challenge. Critical GMP processes and process steps are mapped, supported and controlled by a complex IT landscape today. An extremely disciplined, planned and professional approach to validation is required here in order to simultaneously meet the requirements of GMP rules and regulations, for instance regarding validity and data security. This is only possible when all sides – the operator, IT service provider and quality department – have the required knowledge and speak the same language. Building understanding, enhancing awareness, imparting knowledge.

gempex offers specific, tailor-made in-house training on all topics related to the validation of computer-aided systems. Concretely aligned with the customer’s current situation or the individual IT system and respective software. Performed by GMP IT experts with practical experience. 

From Theory to Practice: “IT Validation” Training Spectrum

The spectrum ranges from general basic training – focusing on terminology, regulatory requirements and process models – to specialised training for the validation of certain system types such as ERP systems or computer-aided production systems. Possible training topics include:

  • basics of IT validation
  • process model according to GAMP 5.0
  • validation of Excel spreadsheets
  • validation of an ERP system
  • and much more

In-house and Tailored to Individual Needs

gempex closely aligns training with customer needs. The content, duration, venue, previous knowledge and number of participants are coordinated in advance, the agenda is jointly developed. Around 10 participants is the recommended number, allowing leeway for more in-depth discussions and interactive exercises. If customers want to be trained in later performing the IT validation themselves, the concrete IT system or individual software and imparting practical knowledge are the focal points. Current problems from an ongoing project can be resolved with focus. If only a fundamental understanding is required, regulatory and interdisciplinary knowledge and methodology competence are imparted. Training provided by gempex always includes an element of consultancy:  approaches are jointly developed and initial basic concepts are discussed. This gives the customer a starting point directly following the training.

Expertise to the 3rd Power +1: GMP, IT, Project Work and Moderation

The instructor is an experienced senior consultant in the IT validation field. This is a clear advantage for the participants: training based on expert GMP knowledge with a direct, practical reference to IT. The gempex instructors are primarily involved in consultancy and the project business. They are both IT and GMP experts. As well as experienced trainers. Expertise to the 3rd power +1.

Benefits

  • complex GMP requirements comprehensibly explained in IT language 
  • in addition to a basic understanding, a clear roadmap is defined for the subsequent approach
  • production, IT and quality employees are all on the same page
  • training that is precisely tailored to individual needs
  • leeway for discussion and interactive exercises 
  • experienced moderators with GMP and IT expertise: know-how and expert knowledge
  • on site with the customer
  • certificates and training documents