In the regulated environment of the life sciences (pharmaceutical and medical technology), computer systems that have an influence on product quality, patient safety or data integrity must be validated according to strict national and international legal requirements and kept in a valid state throughout the entire system life cycle.
Regulatory requirements include EU directives and national drug laws as well as the quality management standard DIN EN ISO 13485 and the requirements of the US Food and Drug Administration (FDA). For pharmaceutical companies, the regulations from 21 CFR Part 11 and EU GMP Annex 11 are also relevant. In most cases, the software validation itself is carried out according to the industry standard GAMP 5.
DHC has more than 20 years of experience in the validation of the most diverse complex computerized systems.
These include ERP systems (SAP, Oracle, Microsoft Dynamics), document management systems (DMS), laboratory information and management systems (LIMS), IT systems in the clinical sector / clinical trial management systems, pharmacovigilance systems, customer developments, spreadsheets and cloud-based systems.
With the experience gained from a large number of successful software validation projects, we have developed over the years a cost-effective and scalable method for the validation of computer systems. The DHC Best Practice Method is a framework consisting of a process model, work instructions (SOPs), templates, training materials and tools (DHC Validation Framework). It covers the entire system lifecycle – from initial implementation, through the operational phase, to decommissioning and data archiving. We are constantly expanding our methodology to include solutions for new regulatory and technological challenges (e.g. machine learning or artificial intelligence)