Quality & Compliance Archive - Qudits AG

Software as a Medical Device (Digital Health)

Qudits — Wed, 29 Mar 2023 09:51:12 +0000

We analyze and evaluate the regulatory requirements for registering a medical device software as a German digital health application (DiGA) using the fast track approach established by the BfArM. This includes performing an MDD-to-MDR gap analysis on technical documentation and determining binding delivery conditions that take into account important factors such as data protection, information security, clinical safety, functionality, and quality. This will help gain a competitive advantage in accessing the medical market.

Der Beitrag Software as a Medical Device (Digital Health) erschien zuerst auf 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.

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.

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.

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.

Introduction of LifeSphere RIMS

Qudits — Mon, 11 Oct 2021 13:11:32 +0000

Introduction of an end-to-end Regulatory Information Management in the cloud (LifeSphere RIMS), migration of data via 5 interfaces as well as definition and training of associated processes with the goal of creating a source that unifies all data and creates a complete overview of the status of all documentation. More efficient structures and solving the challenges of previous applications provide a higher quality in data management. Efficient project planning with a test matrix to track all ongoing activities and a total of 875+ test steps ensured that resources were used sparingly.

Der Beitrag Introduction of LifeSphere RIMS erschien zuerst auf Qudits AG.

Digitization of manufacturing processes

Qudits — Fri, 17 Apr 2020 16:29:29 +0000

The introduction of the Veeva Vault solution creates a digital, harmonized, and agile end-to-end manufacturing process that can be seamlessly integrated into the existing system landscape. This simplifies processes on a global scale and reduces operating costs by 20%.

Der Beitrag Digitization of manufacturing processes erschien zuerst auf Qudits AG.

Portfolio management for GxP-relevant applications

admin — Mon, 17 Feb 2020 06:56:20 +0000

The introduction and global rollout of a customized, cloud-based portfolio management system for all GxP-relevant applications improves data quality and thus decision-making. Approval workflows ensure that the validated status is maintained.

Der Beitrag Portfolio management for GxP-relevant applications erschien zuerst auf Qudits AG.