QFINITY · Projects · Project News
A look inside our project work.
An overview of the projects QFINITY takes on for its clients - a look at how we work and at the projects we have already delivered in the GxP-regulated environment.
Current projects
INTRODUCTION OF A PARTICLE MONITORING SYSTEM IN A PHARMACEUTICAL PRODUCTION FACILITY
A pharmaceutical manufacturer implemented a computerized particle monitoring system within a tight production window. QFINITY analyzed the manufacturer’s and SAT documentation and derived a highly efficient documentation approach that enabled implementation and release on time and in regulatory compliance.
The project
QFINITY supported a pharmaceutical manufacturer in implementing and validating a computerized particle monitoring system.
The project covered processes and services for validation planning and execution. It also covered coordinating and following up on documentation activities at both the pharmaceutical company and the manufacturer of the particle monitoring system. The pharmaceutical company could only implement the system in production within a limited time frame. This called for an approach that would fit that window and still ensure conformity with all regulations. It required a detailed analysis of the system manufacturer’s documentation, including site acceptance testing. Based on this analysis, QFINITY defined a highly efficient documentation approach for implementing and releasing the system within the specified time frame.
The goal
This project aimed to comprehensively introduce and validate a particle monitoring system at a pharmaceutical manufacturer. A key priority was ensuring that the system’s installation and validation met the pharmaceutical industry’s strict requirements and complied with all relevant regulations. The new system would enable continuous monitoring and analysis of particle contamination to ensure product quality and safe production processes. Implementation took place within a clearly defined timeframe to maintain operational continuity and meet the planned milestones.
The project helped secure the highest quality standards, minimize risks, and increase efficiency in pharmaceutical production.
Still have questions about validating a particle monitoring system?
What are the critical success factors when implementing a PMS within the given timeframe?
What initial obstacles must be expected in such a project?
Do you need help with a similar project? Then please contact us using our contact form. You can find more information about our services under Service. Feel free to take a look there.
INTRODUCTION OF A DOCUMENT MANAGEMENT SYSTEM (DMS)
A company replaced its paper-based and outdated document processes with a central document management system. QFINITY took on both project and validation lead – from requirements-based system selection through a validated prototype to the phased replacement of the legacy system.
The project
This project centers on introducing a document management system (DMS). QFINITY takes on the combined role of project manager and validation manager.
With QFINITY’s support, the company ran a system selection that covered the requirements of all areas (company-wide) and included them in the selection process (user acceptance). The basis was a company-wide specification sheet created beforehand. A clearly structured evaluation scheme led to the decision for a service provider (Oct. 2023), and the project was set up for a phased implementation. The aim was to reduce approval times and set up a collaboration platform with centralized access to all documents in the company – including validation, electronic signatures, full-text search, workflow support, and the option of adding further solutions in the long term.
In phase 1, a prototype for a specific set of documents (development documentation) was introduced and went live in August 2024.
The project is currently in phase 2, replacing the old DMS, which primarily covered SOPs and their read-and-understood confirmations. The new system now also handles template management and special topics around read-and-understood confirmations.
After the planned go-live in 2025, further document types will be introduced step by step.
The goal
The project to introduce a new document management system (DMS) aims to completely replace and modernize all paper-based and simple electronically managed documents. This includes migrating documents from the existing intranet, an outdated SOP management system, and the previous read-and-understood system. The project will introduce a central, modern DMS that significantly improves how documents are managed, traced, and updated.
The goal is a standardized, user-friendly platform that simplifies access to documents, automates processes, and ensures compliance with regulatory requirements. The new system will also store documents in an audit-proof manner and make work more efficient by reducing paper-based workflows and optimizing electronic document processes. Introducing the DMS will improve the transparency, consistency, and availability of documents, leading to higher productivity and better adherence to compliance requirements.
Any questions about introducing a document management system?
What challenges can arise when introducing a document management system?
Do you need help with a similar project? Then please contact us using our contact form. You can find more information about our services under Service. Feel free to take a look there.