QFINITY · Updates
The latest from QFINITY and the field.
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
At a glance
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
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.
Implementation of a Field Service Management Solution based on Salesforce
To support its Field Service Management, a medical device manufacturer plans to implement a Salesforce-based software solution. The goal is primarily to collect information on key indicators. As part of this project, QFINITY∞ plays a supporting role, for example in analyzing the requirements, performing risk analyses, and ensuring GxP-compliant implementation of the system (Audit Trail, handwritten signatures on electronic devices). The project includes creating a GxP-compliant template for worldwide rollout (multi-site approach).