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, whereas compliance is really becoming 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, with audits, CAPA and complaints in separate systems, and finance-oriented control functions such as the internal control system or internal audit running 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 that is GxP-compliant and effective in operation rather than merely documented. Free initial consultation, about 30 minutes.
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