Software Validation

Many different software systems are used in today’s life science industry in order to support and control processes and process steps. But software systems used to perform GMP-related tasks are subject to mandatory validation according to 21 CFR Part 11 or Annex 11. A challenge that can be overcome! From ERP systems to document management systems (DMS), laboratory information management systems (LIMS) or others: gempex provides support for all forms of software validation. In addition to a GAMP-compliant approach, the focus here is on three key aspects: comprehensibility, pragmatism and transparency.

From consultancy to a full implementation with project coordination – gempex is flexible in providing the support the customer needs. The result are clearly comprehensible, efficient and inspection-ready solutions.

Comprehensibility – Bringing Together the Process Owner, IT Specialists and Quality Assurance

Software validation in a GMP-regulated environment is an interdisciplinary task. Here the process owner, IT specialists and quality assurance have to work together closely – a key success factor in projects. This requires a uniform understanding of the subject matter and issues. For instancs, when IT risks or solution concepts are discussed, changes to the GMP rules and regulations mentioned or process technology details described, this must be comprehensible for all participants. With their triple qualification in IT, quality management and production processes, gempex consultants are ideal project partners here. They present even complex issues in a form that is comprehensible for all professional groups. They are “interpreters”.

Pragmatism – Risk-based Approach, Clear and Structured Procedure

A structured and pragmatic approach is especially important for a topic as complex as software validation. For gempex this means the clear alignment of all activities with the three higher-level goals of patient safety, product quality and data integrity – without losing sight of cost effectiveness. This is achieved through a strict risk-based approach: only system modules that perform tasks or map processes critical to quality have to be validated and are subject to further evaluation in the course of risk analyses. Measured validation according to criticality.  

The required activities are clearly planned, responsibilities are established and the individual steps in the validation plan are carried out. This also provides a traceable basis for inspections.        

Transparency and Efficient Project Execution in One

Transparency in software validation projects is assured by gempex from the outset. Even complex problems are broken down into clearly comprehensible steps and calculable work packages, starting with offer preparation. Since these projects normally involve cooperation between the customer, system supplier and gempex, who does what and when for validation is clarified with the customer in advance. Meaningful responsibilities are defined and costs are kept down. On request project management is also handled by gempex.


  • combined IT and GMP expertise
  • calculable, clearly comprehensible work packages
  • additional resources
  • delivery of templates for validation documents
  • independent perspective of GMP experts
  • validation documents that meet legal requirements
  • inspection readiness