Our Projects in Practice

The requirements for the validation routine were evaluated and ensured by a validated PowerShell script. The script was fully documented and validated for GMP use.

Scope of services: network segmentation, definition of firewall rules, and use of a USB dongle in the server rack for the USB licence of a virtually installed software.

After validation of the script, deployment in the GMP environment was unobstructed. Full documentation and validation in accordance with GMP requirements.

Full assumption of project leadership for the migration to the cloud, ensuring all current system functionalities remain available.

By using fibre optic technology, link aggregation, and VLAN segmentation, we achieved a stable and fast connection between the buildings.

To prepare the backup process, we developed various batch scripts that are launched either event- or time-controlled. Documented and validated for GMP deployment.

Planning, organisation and control of the entire project in accordance with GxP requirements through to complete qualification and release for regulated use.

Weighing data is transferred to a validated Excel sheet on a terminal server (audit trail function). Permanent data storage ensured via a connected SQL server.

Creation of all qualification documents and validated measurement reports. The user concept and file system permissions fully closed all data integrity gaps.

Complete equipment documentation and qualification for the pharmaceutical industry. Accompanied FATs with international customers at the machine manufacturer's site.

Development of all qualification documents and execution of qualification and fault management by cube one GmbH.

Ensuring 21 CFR Part 11 compliance and connecting the equipment to a server. GLP-compliant verification of connectivity and functionality according to customer requirements.

For a pharmaceutical supplier manufacturing filter cloths, PLC modules were validated and loop checks performed to qualify the control system.

Complete retrospective qualification to current GMP standard, including all required qualification documents.

Ensuring 21 CFR Part 11 compliance and verification of the manufacturer's IQ, OQ and PQ as well as customer-specific requirements (device category CAT III).

Numerous successfully completed projects with national and international pharmaceutical customers from documentation to completion report.

Thorough testing of the complex software modules by our IT specialists. Configuration, IQ/OQ verification and complete analysis on the test subject.

Ensuring 21 CFR Part 11 compliance and server connectivity. GLP-compliant verification of connection and device functionality according to customer requirements.

Gap assessment, development and validation of scripts to remedy audit trail deficiencies. Linux device connected to Windows PC with automatic transfer to an archive system.

Closure of data integrity gaps by our IT specialists, followed by GxP qualification with IQ/OQ testing, user training and customer-specific requirements.

Verification of data integrity aspects and general customer requirements. Complete qualification documentation for regulated GLP operation.

Complete qualification documentation and execution for regulated laboratory operation in accordance with current GxP requirements.

Qualification of the measurement system in accordance with current GMP requirements, including complete documentation for regulated pharmaceutical use.

Complete qualification documentation and execution for use in pharmaceutical analytics in accordance with current GMP requirements.

Complete GxP qualification for use in pharmaceutical or biotechnological analysis, including all required qualification documents.

Flexible action and close coordination with key users prevented delays, as laboratory instruments could usually only be taken offline for brief periods during connection work.

Input mask for data entry and template selection. The tool automatically populates label templates with the entered data and submits the print job.

Development in .NET with SQL database and design of the data connection between the ERP system and the project planning application.

Access database now serves only as a frontend. The SQL database enabled control system connectivity. Data migration and documentation successfully finalised.

SharePoint server ensures simultaneous multi-user access. Contracts between customer and service providers are automatically generated by the software.

Continuous updating of shift data in the dashboard. Improved overview of shifts for more efficient planning and management for the customer.

Scope: data wrapper development, tag preparation on the PLC and software validation. Programming in .NET/SQL.

Implementation of the check digit calculation according to ECB and Bundesbank specifications in PHP7 for an internet marketing customer.

Development of a laboratory automation solution with Windows PowerShell and RegEx for automated report migration to the shared network path.

Creation of technical functional specifications, programming in S7 Graph and creation/animation of plant screens for WinCC Flexible for a pharmaceutical supplier.

GxP-compliant tool with fully traceable data storage, data-integrity-compliant standard and audit trail function on the Citrix/terminal server.

Elegant solution for optimising PDF document management: consolidation and ELN integration via API through a graphical user interface in Python.

The app can be run directly in a Microsoft Teams channel and serves as a central overview and management tool for Excel spreadsheets and metadata.

Time-based NAS activation via WoL, backup of all containers and VMs, followed by automatic shutdown of the backup NAS via SSH: fully automated.

Data migration to the SQL server, adaptation of VBA code and Windows Forms frontend for intuitive operation. Significant performance and scalability improvements.

Transfer from the old backend to the SQL server and adaptation of the VBA code in the MS Access frontend. Improved performance, scalability and interoperability.

Configuration and implementation of Power Automate Flows for customers to automate and efficiently manage work processes in the Office 365 environment.

Complete change control management for the relocation of laboratory equipment, including GxP-compliant documentation of all change requests.

Description and evaluation of software and process in an FMEA. Creation of IQ/OQ test plans for GxP-compliant validation of the system.

Validated Excel template with sheet protection, password protection and structure protection. Audit trail function enables GMP-compliant, data-integrity-standard-compliant operation.

Creation and documented execution of installation, functional and performance qualification. Coordination and monitoring of defect resolution.

Identified pitfalls (leading zeros, currency formats, date formats, special characters) documented in the CSV import guide. Foundation for validation planning and execution.

Migration of raw data to a SQL database for performance reasons. Documented testing of data migration and access restrictions in the software validation.

The server-based software handles all administrative evaluation tasks. Via software modules, it is coupled to the equipment's evaluation software.

Dedicated team for individual customisations, software updates, data migrations, mobile apps, queries and reports in the pharmaceutical environment.

For the plant relocation: reconciliation of P&I (piping and instrumentation) diagrams, creation of PLT and EMSR lists, and preparation of the user requirements specification.

From inventory analysis of the existing system and market research with presentations through to installation, data migration and process adaptation for the new system.

Migration to SQL server, integration of process control system data and complete project planning and coordination of a project team of 5 employees.

Development of a data integrity questionnaire, gap assessments, closure of gaps and final requalification in close collaboration with the specialist laboratories.

Time, cost and resource planning, milestone definition and project controlling in parallel with server administration by cube one GmbH.

Validation of version update, data migration, individual customisations and IBM Cognos data warehouse. Development, execution and management of ~1,250 test cases.

Project management for the global rollout. Establishing communication channels between IT and laboratories as the key factor for a smooth project progression.

Identification of all key functions of the legacy application and coordination between IT and laboratory for a successful reprogramming based on the electronic notebook.

Data integrity gap assessment at the software manufacturer and creation of complete validation documentation. End-to-end project support in three roles.

Detailed vendor discussions, criteria definition and software selection. Support for the pilot implementation with planning for a long-term global rollout.

As project manager, we accompanied a PoC project to develop a new NMR data evaluation method. Accelerated analysis improves laboratory planning for researchers.

Collaboration between IT and laboratories for vendor selection. Thorough testing of the software solution and pilot implementation under our planning and leadership.

Setup and validation of the end-to-end client-server solution. Location-independent data access and analysis for the customer as the final outcome.

Coordination of all detailed migration discussions between the customer's internal IT and the software manufacturer for the final cloud launch.

Ensuring system integration and support during pilot implementation. The large number of interfaces required particularly careful planning.