Tool for automated statistical check of control limits
The service is requested as part of the project “Tool for automated statistical check of control limits”. The project is started for the team data processing within the group Center of Competence Statistics in the unit Quality BioPharma Operations.
The CPV team's main task is to fulfill regulatory requirements within Continued Process Verification (CPV), where in regular periods product-specific quality and production process of biopharmaceutical products is statistically analysed, discussed and documented.
Therefore, data of defined quality relevant attributes, which are analyzed during the production process, are checked against statistical limits. If those limits are exceeded, reasons for those abnormalities are to be found and actions initiated, if required. Of high importance is the correct and data driven definition of the limits, which are calculated statistically based on historic data.
Due to changes or improvements within the process, uncritical changes in the process data can occur over time. As a result, the limits need to be checked regularly against current data and adapted, if necessary.
This check of limits is currently established as a new requirement for the described overall CPV process. A statistical algorithm for this regular check of control limits has already been developed by statisticians within a module in the programming language GNU R. The statistical module will be provided to the contractor at the beginning of the project.
The project is to develop a tool that makes the statistical module usefully available according to pre-defined user requirements, while integrating it within the overall CPV process.
An interface shall be established between the statistical module and the new tool. The results of the statistical analysis shall be saved in a MS SQL data base.
A user interface shall be established for the users to manage the data evaluation, to present and select raw data, to display the results and graphics as well as to compare the current evaluation with historical evaluations.
The required raw data for the project will be provided via data entities at the beginning of the project.
A software that is based on Visual C#, is already available and established in the team. It supports the described CPV process with its integrated functionalities and is used intensively in daily work of the team. The new tool within this project shall be compatible with it.
The contractor receives relevant access, contacts, inputs for the tool and detailed URs at the beginning of the project. Finalization and functionalities of the tool are verified by BI before release.
The scope of services includes the following tasks, which are independently performed by the external contractor:
- Development of a program module (tool)
o Independent development of functionalities and user interfaces
o According to pre-defined user requirements (URs), which will be provided to the contractor at the beginning of the project
- Interface Configuration
o Possibility to integrate tool in existing CPV software (Visual C# project)
- Start of tool in CPV software
- Data delivery from CPV software via data entity
- Quitting of tool from CPV software
o Integration of existing statistical module (GNU R) into tool
- Start of statistical module
- Data delivery from tool to statistical module (from data entity)
- Surveillance of the statistical module while calculation
- Takeover of calculated results and graphics from statistical module
- Quitting of statistical module
- Minor adaptions in statistical module are necessary
o Save results of statistical module in MS SQL data base
- Structured saving of results and graphics from statistical module and further data in MS SQL data base
- Read saved data from MS SQL data base
- Integration of user interfaces for implementation of defined functionalities
- Display and select raw data from statistical module
- Entry of data relevant for calculation by user
- Control of analysis via statistical module
- Display of results and graphics from statistical module
- User-driven save of results in MS SQL data base
- User-driven reading of results from MS SQL data base
- Comparison of results from current analyses and historic analyses
- Catch errors in programming and display messages on errors and information
- Error in program sequence of tool
- Error in program sequence of statistical module
o Plausibility checks for user-driven data entry by user
- Documentation (subject to approval by BI)
o Automated and repeatable development tests need to be performed and documented
o Code needs to be documented comprehensibly
o A system documentation needs to be created
o A user manual needs to be created
o Documentation in English or German
o No GMP-relevant documentation needs to be created
- 4 hours workshop at the beginning of the project
o Introduction CPV process
o Introduction of project
o Introduction of existing CPV software and documentation
o Handover of GNU R statistical module to the contractor
o Handover of interfaces to the contractor (data, data base)
o Questions and clarifications
- Bi-weekly 1 hour project team meetings
o Presentation of work progress
o Upcoming questions and problems
o Delivery of test versions / prototypes from the contractor, if available
- First prototype latest after 1 month
o Definition of test tasks for the users
- 4 hours workshop at the end of the project
o Presentation of final tool
o Questions and clarifications
o Handover of final tool (subject to approval by BI)
o Handover of final documentation (subject to approval by BI)
The performance of the contractor has the goal to develop an independent and completed program module (tool) for the automated check of existing control limits of quality relevant attributes in the biopharmaceutical production process, which meets the pre-defined user requirements (URs) and the following criteria:
- The tool shall be implemented as an independent DLL (Dynamic Link Library)
- The tool shall be possible to integrate into already available and established CPV software (Start and using module from CPV software possible)
- Programming language and environment for the tool in scope of this project is Visual C# (Visual Studio 2017, .Net Framework 4.X)
o Programming language and environment for existing statistical algorithm is Visual GNU R, Version 4.0.5