Portfolio & Projects Archive - Qudits AG

Regulatory assessment for a biocidal product

Qudits — Thu, 16 Feb 2023 10:09:05 +0000

The biocidal applicability and hereafter requirements as well as costs and timelines for the registration of an innovative antimicrobial biocidal product are investigated, the registration options are evaluated and visualized into a clear basis for decision-making regarding further use and distribution in the EU and Switzerland for the management. In addition to the project management, we are responsible for evaluating the active ingredient identity and clarifying the regulatory status, summarizing the national registration requirements in Switzerland and the EU, and developing strategic recommendations for action.

Der Beitrag Regulatory assessment for a biocidal product erschien zuerst auf Qudits AG.

Digitalization of a new law

Qudits — Thu, 26 Jan 2023 14:47:33 +0000

Creation of the basis for digital application up to release/rejection by a new commission. Associated processes as well as a scalable, individual system solution are developed in an agile manner and inserted into the existing IT architecture of the Canton in accordance with the requirements of a records system. HERMES 5.1 is applied efficiently and special attention is devoted to the needs of the individual stakeholders.

Der Beitrag Digitalization of a new law erschien zuerst auf Qudits AG.

Modern mobile office concepts

Qudits — Thu, 26 Jan 2023 14:30:05 +0000

With the expiry of the lease of one location, all activities in the region are to be consolidated at one innovation hub and modern workplaces are to be created. Project management and coordination of the timely relocation of around 500 workstations, including the introduction of a modern mobile office concept and the infrastructure for a desk sharing booking system that enables flexible working in the office and at home.

Der Beitrag Modern mobile office concepts erschien zuerst auf Qudits AG.

Migration and validation of a critical database

Qudits — Wed, 30 Nov 2022 12:54:26 +0000

The regulatory-critical database of a pharmaceutical company is migrated from Oracle 11 to MSSQL, tested and validated according to GAMP5. By introducing efficient project structures, the deadline of only two months can be met without interrupting business processes.

Der Beitrag Migration and validation of a critical database erschien zuerst auf Qudits AG.

Introduction of a canton-wide monitoring system

Qudits — Wed, 30 Nov 2022 12:50:20 +0000

Harmonization through the introduction of central and continuous end-to-end monitoring of a cantonal administration reduces the complexity of interfaces and responsibilities. By replacing the existing individual solutions, license savings can also be generated. What's special: The combination of HERMES and SCRUM ensures an efficient project structure and handles all activities in simplified sprints.

Der Beitrag Introduction of a canton-wide monitoring system erschien zuerst auf Qudits AG.

Validation of Digitalized Regulatory Affairs Processes

Qudits — Wed, 30 Nov 2022 12:45:59 +0000

Automation of regulatory affairs business processes through the introduction of rule-based workflows. The implementation and validation of a digital platform solution (SaaS) enhances the management of electronic submissions and regulatory documents. This streamlines the compilation, publication, approval and management of regulatory activities in the lifecycle of pharmaceutical products. With this approach we enable and ensure that legacy systems are replaced, and data is migrated correctly and completely in a timely manner to maintain GxP compliance.

Der Beitrag Validation of Digitalized Regulatory Affairs Processes erschien zuerst auf Qudits AG.

Cause/effect in the context of location promotion

Qudits — Wed, 30 Nov 2022 12:38:49 +0000

Developing a cause/effect chain that maps the complex interrelationships and challenges in the overall macroeconomic context through workshops with representatives from the various divisions of a cantonal location promotion department. A specially designed dashboard with measurable KPIs serves the continuous monitoring of the identified success factors, objectives and influencing variables.

Der Beitrag Cause/effect in the context of location promotion erschien zuerst auf Qudits AG.

Validation of a regulatory critical application

Qudits — Wed, 30 Nov 2022 12:35:24 +0000

Successfully updated and validated a pharmaceutical company's regulatory critical application within a tight timeframe. Established efficient structures, closely tracked all activities, and quickly resolved challenges to ensure compliance without prolonged business process disruptions.

Der Beitrag Validation of a regulatory critical application erschien zuerst auf Qudits AG.

Data migration after divestment

Qudits — Thu, 16 Dec 2021 13:41:38 +0000

In the course of the divestment of a corporate unit, the data of nine locations is migrated from the existing intranet solution to MS SharePoint, including critical data covered by the Chemical Weapons Convention. This enables online collaboration and - thanks to clean-up and restructuring - increases data quality. Efficient migration planning means daily operations are not impacted.

Der Beitrag Data migration after divestment erschien zuerst auf Qudits AG.

Project excellence in quality control

Qudits — Mon, 11 Oct 2021 13:14:19 +0000

Introduction and harmonization of agile portfolio, project and resource management for the successful management of all at times complex initiatives and projects in the lab environment. The central project control processes increase transparency in planning and sustainably support the corporate strategy and associated growth targets.

Der Beitrag Project excellence in quality control erschien zuerst auf Qudits AG.