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Shaping the regulated quality of tomorrow.
Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
Latest articles
Audit of the GCP Safety Processes and the underlying computerized systems of a small/midsize CRO
A small-to-midsize CRO contracts QFINITY∞ to conduct an audit of the safety processes and the underlying computerized systems. The audit included an assessment of the validation status of the pharmacovigilance software in use at the CRO.
Approach to the Qualification of IT infrastructure
As part of centralizing its IT services, a pharmaceutical manufacturer has contracted QFINITY to support the implementation of an approach for qualifying the IT infrastructure. QFINITY∞ provides coaching through client workshops to build the basic knowledge that serves as a foundation for its ongoing support.
Data Integrity – Workshop and Gap Analysis
An API manufacturer wants to conduct a data integrity analysis in preparation for an FDA audit planned in the medium term. QFINITY∞ is training the client in the basics of GxP, CSV and data integrity and is analyzing the systems (automation, laboratory and IT) in order to derive an action plan to ensure conformity with requirements.