Enterprise management systems as the basis for GxP compliance.
In Pharm. Ind. 79 (2017), Dr. Stefan Schaaf (Q-FINITY Qualitätsmanagement) describes why GxP compliance does not rest on the management manual but on the processes: an enterprise management system integrates quality, governance, risk and strategy into a control loop - instead of producing documentation for the auditor.
GxP compliance begins with the process, not the manual.
The article argues that many still equate quality with documenting - when compliance is really a system, an operational instrument. The backdrop is a shift among regulators: European authorities and the FDA are aligning pharma and medtech topics, and ISO 9001:2015 makes process orientation and risk-based thinking mandatory - the once-obligatory management manual gives way to the "documented information" that arises directly from the process.
The key points at a glance.
From the management manual to a living system.
The article takes a sober look at the status quo: many companies run parallel worlds - audits, CAPA and complaints in separate systems, finance-oriented control functions such as the internal control system or internal audit alongside quality management. What is missing is integration. This is exactly where the enterprise management system comes in: the purpose comes from the process and its intended use, not from the IT system - the system merely supplies the data foundation, while organizational responsibility rests with the process. That holds beyond GxP-relevant systems too, for instance for business-critical systems under SOX or GDPdU.
Written from quality management practice.
Dr. Stefan Schaaf (Q-FINITY Qualitätsmanagement, Dillingen) wrote the article, combining the management-system and GxP perspectives - an outlook that shapes QFINITY's work to this day. The article appeared in Pharm. Ind. 79, No. 12, pp. 1644-1650 (2017) at ECV Editio Cantor Verlag, Aulendorf, as an updated version from "IT-Trends im GxP-Umfeld" (ed. by Concept Heidelberg, 2015); copyright and full text rest with the publisher.
From thesis to practice.
Quality as a working system.
We work with you to determine whether your processes, metrics and risk assessments can sustain an integrated management system - GxP-compliant and effective in operation, not merely documented. Free initial consultation, about 30 minutes.
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