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For a server-client system for controlling and data recording of laser diffraction devices, cube one GmbH set up the server and clients according to customer-specific requirements.
Our services also included defining and implementing network segmentation and its firewall rules. Additionally, a USB dongle was used in the server rack, as the used software was installed on a virtual server and required access to a USB license dongle.
Due to a required nomenclature of filenames generated through a manual process during a GMP measurement, a method had to be found to consistently adhere to file naming conventions.
To realize this, the requirements for the validation routine were evaluated and ensured through a validated PowerShell script.
Due to the further processing of measurement data stored on a network share, a script had to be developed.
Based on file attributes, automatic sorting is automated through a PowerShell script during the copying process.
After validation of the script, its use in the GMP environment was also cleared.
To secure regulatory-relevant data collected in GMP laboratories in the pharmaceutical environment, our customers employ a qualified backup solution.
In preparation for the backup process, we developed various batch scripts that are triggered event-based or time-controlled.
For use in the GMP environment, the scripts were documented and validated.
A customer from the beverage industry wanted to implement a comprehensive network across their factory buildings.
By using fiber optic technology, channel bundling, and segmentation through VLANs, we were able to achieve a stable and fast connection between the buildings.
To ensure that our customer’s system can be serviced with all current functionalities, we took over project management for the migration to the cloud.
To successfully implement the project, regular coordination with the IT department of our customer and the software manufacturer was required.
Project management in software development is a critical discipline that serves to effectively plan, organize, and control software projects.
For an alternative process in pharmaceutical production, two additional weighing robot systems, consisting of standalone scales and instrumentation PCs, were qualified.
For a data integrity-compliant process, the weighing data is transferred to a validated Excel sheet, which is provided on a terminal server and features an audit trail function.
Permanent data storage is ensured by an integrated SQL server.
For our customer from the pharmaceutical industry, we qualified a weighing robot for use in the GMP environment.
The qualification included the creation of qualification documents IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification). Additionally, measurement reports were developed and validated based on a validated Excel file.
The focus of the qualification was the development of solutions for closing data integrity gaps. By developing and implementing a user concept and configuring file system permissions, all data integrity gaps could be closed.
cube one GmbH supported a Swiss pharmaceutical supplier for leak testing machines in plant documentation FDS (Functional Design Specification), HDS (Hardware Design Specification), as well as the creation of qualification documents RA (Risk Assessment), TA (Trace Ability), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) for use in the pharmaceutical industry.
We accompanied the execution of FATs (Factory Acceptance Tests) with international customers.
In the field of pharmaceutical veterinary medicine, a mixing equipment was used that homogenizes under vacuum.
cube one GmbH organized, accompanied, and documented the FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). For use in the pharmaceutical environment, the qualification documents RA (Risk Assessment), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) were developed and compiled.
The qualification and error management were also carried out by us.
For our customer from the pharmaceutical industry, we qualified a tablet press using the retrospective approach.
For a pharmaceutical supplier manufacturing filter cloths using a long-screen machine, cube one GmbH validated PLC modules/blocks and conducted actuator/sensor loop checks to qualify the control system.
For a pharmaceutical supplier, we supervised the FAT (Factory Acceptance Test) and SAT (Site Acceptance Test), as well as the on-site qualification at the end customer.
From compiling the plant documentation to the qualification completion report, we have supported numerous successful projects with national and international pharmaceutical customers.
A profile projector is used to measure dimensions of non-transparent components through optical measurement: diameters, radii, distances between points and lines on the component, e.g., Extended Finger Flange, rubber stoppers.
Our initial task was to ensure the system’s conformity with the requirements of 21 CFR Part 11 for ERES (Electronic Record, Electronic Signature) was implemented.
During the qualification (device category CAT III: Raw data and test results are stored and can be edited), the manufacturer’s IQ, OQ, and PQ and customer-specific requirements were examined.
A fracture strength tester is used for testing the hardness, length/diameter, width, thickness, as well as weight/mass of tablets and capsules.
The Electrocardiogram (ECG) is used to record and analyze ECG signals from dogs or minipigs. To ensure data integrity in the GLP environment, the complex software modules that were part of the qualification process were thoroughly examined by our experienced computer scientists.
Subsequently, the components were configured according to customer requirements.
During the qualification process, the manufacturer’s IQ/OQ and customer-specific requirements were verified. This included checking Data Integrity requirements as well as conducting a complete analysis on the test subject.
The Colony Counting System captures and quantifies DNA damages that exist in the form of gene mutations (point mutations, insertions, or deletions).
In addition to ensuring 21 CFR Part 11 compliance with regard to data integrity, another task was to connect the equipment to a server (computer system).
To be able to use the equipment in a GLP-compliant manner, the qualification process involved checking both the connection to the computer system and the equipment’s function according to customer requirements.
With a flow cytometer, for example, fixed blood cells are incubated with various fluorescence-labeled antibodies or fluorescent dyes and subsequently detected or measured using lasers (micronucleus test).
The device is used in the GLP environment for measuring and analyzing toxicological tests. Initially, a Data Integrity assessment was conducted to identify gaps, which were then closed with the help of our computer scientists. This included writing scripts that were validated during the qualification process to eliminate deficiencies in the audit trail.
Another task was to connect the Linux-based device to a Windows PC and transfer all relevant data (calibration, measurements, audit trail) to a separate archive system.
A gel documentation system serves to document fluorescence-labeled DNA and RNA in agarose gels.
Our initial task consisted of a Data Integrity GAP analysis and ensuring 21 CFR Part 11 compliance. The identified Data Integrity gaps were resolved by our experienced computer scientists, allowing subsequent qualification for operation in the GxP environment.
During the qualification, the manufacturer’s Installation Qualification/Operational Qualification (IQ/OQ), training for users and administrators, and customer-specific requirements were examined.
The Real-Time PCR LightCycler is used for quantitative and qualitative determination of nucleic acids
A polarimeter is used to determine the optical rotation angle for GMP-compliant and non-GMP-compliant analyses of pharmaceutical raw materials, auxiliary substances, and active ingredients.
Using the Comet Assay (Single Cell Gel Electrophoresis), primary DNA effects such as DNA single-strand breaks, double-strand breaks, and alkali-labile sites can be detected.
In addition to ensuring 21 CFR Part 11 compliance with regard to data integrity, another task was to connect the equipment to a server (computer system).
To be able to use the equipment in a GLP-compliant manner, the qualification process involved checking both the connection to the computer system and the equipment’s function according to customer requirements.
A Slide Scanner is used to create digital Whole Slide Images (WSIs) of histological slides.
These serve as a reference within GLP studies. During the qualification process, both data integrity aspects and the customer’s general equipment requirements were reviewed.
An insulation system is employed for the purification of nucleic acids as a preparatory step for subsequent analysis via Real-Time PCR.
For one of our customers, project managers from cube one GmbH took over project management for the global introduction of a data backup tool for laboratory equipment across various corporate departments.
For each project, the target was defined in terms of how many laboratory equipment units were to be connected to the data backup tool. Together with the project team, the rollout process was planned as an agile project.
This required particularly flexible action and close communication with the primary users of the equipment to prevent delays in the rollout, as laboratory devices could typically only be locked down for a short time during connection.
For the GMP laboratory area of a customer, a tool was needed for automated label printing. The project was implemented using Excel VBA programming.
An input mask serves for data entry and selection of label templates. The tool fills the templates with the entered data and automatically submits the print job.
For an engineering firm, we developed project planning software for project planning and billing. The software was developed with .NET and stores the data in a Microsoft SQL database.
The planning and conception of data integration between the inventory management system and the project planning software was also part of our service portfolio.
Our customer, who supplies pharmaceutical companies, used an Access database for production-accompanying documentation of distribution.
Due to the numerous users, the Access database reached its limit of simultaneous accesses. As a solution, cube one GmbH outsourced the data from the Access database to an SQL server and now uses the Access database only as a frontend. A significant speed advantage was achieved, and the SQL database enabled the connection to the control system.
Data migration and its documentation were also part of the project, which cube one GmbH successfully finalized.
For a customer, a Python pipeline was developed that automatically retrieves data from a network share on a daily basis, converts it, and makes it available for the Shiftconnector Dashboard.
This interface ensures continuous updating of shift data in the Shiftconnector Dashboard. This provides the customer with a better overview of shifts, contributing to improved efficiency and accuracy of shift planning and management.
The project involved automating a decentralized backup solution for a Linux server using a Bash script.
The task was to decentrally secure all containers and VMs used in the Proxmox virtualization system.
For this purpose, a NAS was time-based activated via Wake-on-LAN (WoL).
Subsequently, the backup of containers and VMs was performed. The backup NAS was then shut down via SSH.
A pharmaceutical supplier used a database for batch-related documentation of its products and needed software that inserts quality-relevant data from the process control system into the database.
Our scope of services included the development of the data wrapper, tag preparation on the PLC (Programmable Logic Controller), and software validation. The software was programmed in .NET/SQL.
Our customer from the internet marketing industry needed verification of International Bank Account Numbers (IBAN) for their validity in billing via SEPA direct debit mandate.
The programming implementation was realized in PHP7 and according to the checksum calculation specifications of the European Central Bank (ECB) and German Federal Bank.
For our customer, we developed a laboratory automation solution to migrate reports based on file name extraction.
This was accomplished using RegEx on a common network path utilizing Windows PowerShell.
For a pharmaceutical supplier, we supported a programming team in automating a production facility.
The facility is controlled via an S7 PLC and was programmed using the S7 programming language.
Our tasks included creating technical functional descriptions, programming step sequences in S7 Graph, programming data blocks and function blocks, as well as creating and dynamizing plant images for visualization with WinCC Flexible.
Our customer from the pharmaceutical industry needed a tool for scanning medication box barcodes and subsequently converting them for easy data transfer to SAP.
The entire process should be traceable and comply with regulatory requirements regarding data integrity.
For implementation, cube one GmbH developed a validated Excel sheet using VBA, which is provided on a Citrix/terminal server and features an audit trail.
The customer’s existing system was migrated from a pure MS Access solution to an SQL Server backend with an MS Access frontend.
The migration was carried out to increase the system’s performance, scalability, and interoperability capabilities.
The migration included transferring the data from the old backend to the SQL Server, as well as adapting the VBA code of the MS Access frontend.
Für unseren Kunden entwickelten wir eine App, welche in einem Microsoft Teams Kanal ausgeführt werden kann.
Diese PowerApp dient zur Übersicht sowie zur Verwaltung von Excel Spreadsheets und deren Metadaten.
The customer’s existing system was migrated from a pure MS Excel solution to an SQL Server backend with an MS Excel frontend.
The majority of the frontend is realized through a Windows Form to ensure a practical and intuitive operation.
By implementing this change, the system’s performance and scalability could be increased. Additionally, parallel usage by multiple users was enabled.
For implementation, data migration to the SQL Server and adaptation of the VBA code in the MS Excel frontend were necessary.
For contract management between a pharmaceutical manufacturer and its service providers, cube one GmbH developed software that was to be embedded into existing infrastructures.
An Access database served as the frontend system with data storage on a SharePoint server. This ensured simultaneous access by multiple users.
The contracts between the customer and its service providers are automatically generated by the software.
We developed an elegant solution for a customer to optimize the management of PDF documents: These were consolidated and integrated into an electronic laboratory notebook (ELN) (using an API, via a graphical user interface and Python).
For our customers, we configured Flows for Microsoft Power Automate in combination with Microsoft Power Apps and the entire Microsoft Suite.
This enables efficient design and automation of work processes.
Creation of over 400 change requests due to equipment relocation from various departments to a central building.
The customer used a customized software for recording production data.
Due to the delivery of electric motors to pharmaceutical end customers, it became necessary to validate the system and the process.
In this project, the software and the process were described and evaluated in a risk analysis (FMEA). The creation of IQ/OQ test plans was also carried out by cube one GmbH.
Our customer uses Excel spreadsheets for standardized calculations in the GxP environment. To ensure controlled versioning and operation in a validated environment, we provide the Excel sheets on a Citrix platform.
A validated Excel template always serves as the basis for new Excel sheets. The template covers functions such as hiding menus, sheet protection, password protection, and structural protection.
Even permanent data storage using an SQL database is possible. With comprehensive solutions such as an audit trail function, we have succeeded in using Excel sheets in the GMP environment in a compliant manner and in accordance with current data integrity requirements.
For monitoring retention rooms in the pharmaceutical environment, data loggers were used for permanent recording and monitoring of room temperature and relative humidity.
The installation, functional, and performance qualifications were created and documented. Error corrections were also coordinated and monitored by cube one GmbH.
For a data migration, our customer needed to export large volumes of data from an old system and import them into a new system.
In this process, cube one GmbH analyzed the potential pitfalls that could occur during the migration and created a CSV import guide for our international pharmaceutical customer, which served as the basis for validation planning and ultimately its implementation.
Pitfalls included, for example, leading zeros, currencies, date formats, and symbols.
A disposition Access database contained a user interface and the raw data. For availability and performance reasons, the raw data was outsourced to an SQL database and linked with the Access user interface.
The data migration and access restriction were documented and tested in the software validation.
Through corresponding modules, the software is coupled with the evaluation software of the equipment.
For data acquisition and reporting in the pharmaceutical sector, our customer uses the software ARIS and IBM Cognos.
Our team creates and maintains the software validation for individual system customizations, software updates, data migrations, mobile apps (applications), queries, and reports.
As project managers and IT administrators, we accompanied the establishment of a knowledge database for our customers in research.
This serves to visualize and filter by medications and diseases and enables the integration of scientific studies.
The database is thus part of the basis for new research projects.
An engineering firm was searching for a new inventory management system.
Our task was first to conduct an inventory of the existing system and define the requirements for the new inventory management system.
After market research, 3 suppliers were commissioned to provide test instances. Following the presentations and a consolidation phase, the selected inventory management system was installed at the client’s site and the data migrated.
Subsequently, the processes were adapted to the new software.
For a pharmaceutical supplier, an existing Access database, which maps the distribution of the manufacturing process, was to be migrated to an SQL server.
Additionally, the new application should store data from the process control system. Besides project planning, the coordination of 5 employees was also part of our services.
Our customer from the pharmaceutical industry initiated a project to review their systems regarding data integrity requirements and simultaneously requalify them.
Our task was to develop a data integrity questionnaire and conduct gap assessments on the devices.
After the gaps were closed, the systems could be requalified. Close collaboration with the specialist departments in the laboratory constantly required smooth communication, project planning, and coordination.
Our customer uses a server-client system for controlling and data recording of laser diffraction devices and thermal analyses.
The servers were to be upgraded from Windows 2012 to Windows 2016 and the clients from Windows 7 to Windows 10. In addition to server administration, cube one GmbH took over project management.
This included time, cost, and resource planning, milestone definition, and project controlling.
Our customer uses the ARIS software in the Pharmacovigilance department, which serves to monitor the safety of a finished pharmaceutical product.
In the project, a version update, data migration, individual customizations, and an IBM Cognos Data Warehouse were validated.
In addition to the development and execution of approximately 1,250 test cases, cube one GmbH took over the planning and management of a test team of 10 employees.
As project managers, we led the global rollout of a new data backup tool for our customer.
The tool serves to secure and migrate GxP-relevant data for long-term and protected storage.
As project managers, we were the interface between the individual corporate departments of our customer and ensured a smooth process during the connection of individual devices to the data backup tool.
Here, it was particularly crucial to mediate and strengthen communication channels between IT and the laboratories to successfully advance the projects.
As project managers, we worked with a customer in the pharmaceutical industry on a project to reprogram a GxP application.
In the project, all important functions of the old application first had to be identified and coordinated between IT and the laboratory to ensure successful programming based on the electronic notebook.
The existing thermal analysis devices of a customer from the pharmaceutical industry were to be integrated into a client-server solution due to Data Integrity requirements. As project managers, validators, and IT administrators, we comprehensively accompanied this process.
This included a Data Integrity Gap Assessment with the software manufacturer as well as the creation of validation documentation.
Our customer’s dissolution systems were to be converted to a client-server solution to improve data integrity.
Initially, our task was to engage in detailed discussions with various software manufacturers to evaluate different software solutions. Various criteria were established based on which a convincing software could subsequently be selected.
As part of the project, the implementation of this software solution was also accompanied at a pilot location. A global rollout of the client-server software will follow in the long term.
As project managers, we accompanied a proof of concept project in which our customers in the pharmaceutical industry developed a new evaluation method for NMR data.
In this project, the analysis of measurement data was to be made more efficient using new mathematical methods.
The accelerated analysis enables researchers to improve the planning of their laboratory workflows.
To improve data integrity, our customer’s FTIR systems were to be converted to a client-server solution. Through collaboration between IT and laboratories, a manufacturer could be selected after several evaluations.
As IT project management, we thoroughly examined the software solution. The system implementation was carried out locally as part of a pilot project, in which we were involved in planning and management.
For our customer in the pharmaceutical industry, we were responsible for project management during a migration project that involved transitioning the entire electronic laboratory notebook to a cloud solution.
Here, it was crucial that the customer’s internal IT department worked closely with the laboratory notebook software manufacturer to plan detailed coordination for the migration and go live in the cloud by the end of the project.
Due to new Data Integrity requirements, our customer in the pharmaceutical industry has already replaced existing particle size measurement systems. As project managers, validators, and IT administrators, we set up and validated a holistic client-server solution.
This allows multiple measurement systems to be integrated into the infrastructure. And the customer now has the opportunity to access and analyze data independently of location.
For our customer in the pharmaceutical industry, an API (Active Pharmaceutical Ingredient) plant was to be relocated.
For the relocation, our tasks included comparing P&I (Piping and Instrumentation) plans and creating PLT (Process Control Technology) lists, as well as developing EMSR (Electrical, Measurement, Control, and Regulation Technology) lists and creating the technical specification document.
Our customer expressed the desire for a new global LIMS system, for which we provided supporting market analysis.
In this process, we worked together with the customer to develop requirements and criteria, narrow down the market, and ultimately select a manufacturer.
This was tested and evaluated in a pilot phase.
To improve data integrity, it was necessary to replace an analysis method that had been established for years.
A client-server solution has proven to be a modern standard. In our role as IT project management, we ensured that the manufacturer’s software solution could be integrated into our customer’s data landscape and supported the implementation at a pilot location.
Particularly interesting about this solution was the multitude of interfaces to other systems, which required better planning for a peripheral field of view.