SOFTWARE / Computer System Validation (CSV)

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 25 years of experience in the validation of a wide variety of complex computer-based systems at SMEs as well as international corporations.

These include ERP systems (SAP, Microsoft Dynamics, Oracle,…), 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 (IT Compliance 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)

We analyse the GxP requirements relevant to you and specify the necessary measures pragmatically based on risk analyses. DHC is characterised not only by its excellent knowledge of computer systems, but especially by its know-how in project and process management as well as its sound industry experience in the life sciences (especially pharmaceuticals) and medical technology.

DHC offers a uniform, methodical, process-oriented and risk-based validation approach. We are guided by the V-model according to the current version of GAMP, the ISO standards and requirements of the FDA (especially 21 CFR Part 11) and the European authorities (especially EU GMP Guide Annex 11). Our approach is tailored to the needs of our customers and fulfils all criteria for a cost and benefit optimised approach. In addition, we take into account the integration into an existing quality management system.

DHC’s portfolio of software validation services  is based on a maturity model for the validation of computer systems: services are offered to support strategic planning and methodological design, to professionally carry out software validation and to permanently ensure the valid state of relevant computer systems.

The service offer consists of standardised “consulting packages” pre-defined in their respective scope of services; it also includes flexibly scalable services for the implementation of validation projects and for needs-based support in company-internal validation projects. The focus is on efficiency in implementation and the sustainability of the results achieved.