CVal - Qualification and Validation in digital Age
Requirements and legal guidelines
In recent years the challenges for pharmaceutical companies increased progressively due to regulatory requirements. New guidelines for quality assurance have been established e.g. the GMP guideline (Good Manufacturing Practice) – Annex 15: Qualification and Validation. Furthermore, the Guidance for Industry, published bythe FDA (Food and Drug Administration of the United States of America), confronts pharmaceutical companies with increasing standards for process validation.
Therefore, predominantly paper-based documents and data should be adapted to be consistent with the increasing and complex requirements for plant qualification and process validation.
State of the art
As a consequence of the changing guidelines, the necessity of digital qualification and validation processes increases. The current prevalent approach of digitalisation of plant qualification and process validation within pharmaceutical companies comprises the creation, completion and modifications of data within various software and archiving systems. The effects of this procedure are redundant and non-as built data, as well as the susceptibility to errors due to the application of various systems and interfaces, inadequate control mechanisms and high-maintenance
data management. As a logical consequence the assurance of data integrity, quality, consistency and currency is impeded.a
The software CVal, developed by J&K and based on the Siemens software COMOS, offers innovative solutions for digital qualification and validation.
CVal will enable companies to perform all qualification and validation processes electronically in a single application.
All relevant data can be reviewed, approved and directly linked to plant equipment. CVal poses an independent solution within COMOS and facilitates the representation of a digital Q&V twin. Due to the virtual representation of data, plants and processes, a consistent object-based connection of the individual process steps is accomplished.
The application offers the possibility to implement processes with the aid of elaborated migration concepts and import/export functions and thereby generates additional interdivisional values for the customer.
CVal combines through specific system functions the following modules under consideration of the current GMP requirements:
- Project specific modules:
- Representation and maintenance
- User Administration of real structures
- Data Management
- Migration of Data
- Specific system function:
- Specification Management
- Traceability Management
- Risk Management
- Change Management
- Test Management
- Documentation Phase Management
- Deviation Management
- Project Phase Management
To perfectly link the data it is recommended to realize an interfaces between COMOS/CVal and SAP.
With CVal qualification and validation activities can be implemented more effectively and the software offers consistent traceability. In addition, data consistency is increased and expanded over the whole process. The data integrity is ensured through control mechanisms. Due to the implementation of a single application, redundant data, interfaces, malfunctions and error-rates of the system are reduced and thus an enhanced data quality is achieved. Further, the comparability of the efficiency and quality of equal plants and sites is enabled via benchmarking. Additionally, processing of integral Key Performance Indicators (KPIs) is enabled.
CVal offers together with COMOS features, which can be rolled out via modules. Hence, J&K provides in cooperation with Siemens a suitable software integration procedure, which allows companies to generate real compositions, to migrate data and to qualify and validate their plants and processes digitally in a central object-based application.
Benefit from our 25-year-lasting Q&V experience combined with over 10 years of engineering/COMOS know how.