Knowledge management in computerised systems validation at GMP facilities: a qualitative interview study with...

Working methods grounded in knowledge management add structure and recurring value creation to organisational processes. For GMP facilities, knowledge management (KM) around the validation of computerised systems could unlock existing knowledge potential and reduce dependence on external consultants, yet the topic is barely addressed in the scientific literature.

To determine which aspects of knowledge management specialists consider suitable for the application and validation of computerised systems, and which aspects have been used since their implementation.

An exploratory qualitative design was applied. Nine semi-structured, guideline-based specialist interviews were conducted in Austrian public-sector GMP pharmacies and tissue banks. Interviews were subsequently analysed by structured qualitative content analysis, using Probst et al. as the deductive framework and inductively derived subcategories.

Statements were coded across all eight building blocks, with the densest coding in knowledge distribution. Documentation, conferences, continuing education and specialist literature formed the backbone of knowledge acquisition. Leadership behaviour, a blame-free culture and flat hierarchies were the decisive enablers of transfer of knowledge. Staff turnover was the principal source of knowledge loss. Knowledge-management aspects were known and partly implemented in every facility, but explicit knowledge goals and their assessment were largely absent.

Knowledge management for CSV is operationalised only to a low degree in the investigated facilities, mainly because of limited public-sector resources, the difficult quantification of benefits and the absence of a holistic organisational commitment. Five recommendations for action are proposed as an empirical concretisation of known methods enriched by newly identified aspects.