1 year ago

Successful validation in regulated sectors

  • Text
  • Validation
  • Software
  • Requirements
  • Regulated
  • Sectors
  • Auvesy
  • Functions
  • Qualification
  • Specifications
  • Copyright

Successful validation in regulated sectors needs to be considered. For example, a network whose bandwidth is too small can severely impair the functions of different systems. If the location of the system in question is situated in a production environment, it will need to be checked in order to determine (1) if there is sufficient memory available and (2) whether the system might be impaired by other components of the same system. While some manufacturers check the basic system requirements during the IQ phase, for others further test steps are necessary. These producers first need for the system to be correctly installed in order to be able to test the basic functions described in the URS successfully. These basic functions are validated using a series of test steps which are based on the general functions described in the URS. The IQ is thus, for some customers, documented proof that a system is compliant with the requirements set out in the URS, and, for others, it is also a basic requirement that assures that the basic requirements for installing a system are fulfilled. The system is checked to make sure that the hardware and software requirements are fulfilled and to confirm that the installation package is available in full. This different approach to viewing the scope of the IQ also brings the scope of the OQ into question. The OQ always concludes with testing the specific functions of a system. The system not only needs to be successfully installed at the designated site, it also needs to fulfil the specific requirements which are set out in the URS. Where the scope of the OQ begins is where opinions begin to differ. One viewpoint is the above viewpoint, which maintains that OQ begins with testing the basic functions of the system. The other viewpoint is that OQ begins with testing the specific functions set out in the URS. Once the OQ has been successfully concluded, the facility is qualified and normal operations can commence. From this point onwards, a regular Performance Qualification will ensure that the facility continues to fulfil the additional requirements set out in the URS. Example of the validation process for a data management system In order to illustrate how the validation process of a software system could be carried out, we will take a look at the data management system versiondog. versiondog is a change management solution for industrial automation. The system can be used to document and create backups of data taken from, among others, PLCs, robots, frequency converters, conveyers, drives, and HMI terminals. It provides one reliable and consistent data backup strategy for rapid disaster recovery. Companies working in regulated sectors, who manufacture in accordance with the GMP criteria set out by the FDA, not only need a backup and recovery strategy for their devices and software programs, but they also need to ensure that all production processes are regularly documented. In order for a data management system for automation to be permitted to operate in GMP regulated sectors, it not only needs to fulfil these requirements but must also be validated in accordance with the validation process displayed in the image below. Fig. 1: Validation process for GMP regulated sectors Copyright AUVESY GmbH · Fichtenstrasse 38 B · 76829 Landau in der Pfalz Date: 04.06.2018 Page 4 of 5

Successful validation in regulated sectors Key to the creation of a complete URS is the combination of the expertise of the operator—with respect to the production environments and product objectives—and the knowledge of the software provider. The creation of the FRA of the system is also achieved in cooperation. This course of action offers a complete and omission-free risk assessment. In the same way, identified potential sources of risk can be quickly reduced. The documentation developed during the course of this cooperation provides the right test steps with which the IQ, and later on the OQ, can be carried out. The close cooperation between the operator and the software provider during the validation process doesn't just have a qualitative benefit, it also helps to (1) conserve human resources at the operating company and (2) to drastically reduce the amount of time that would otherwise be needed in order to complete the process. As shown above, this optimised approach of carrying out system validation gives you the possibility to quickly and regularly carry out a Performance Qualification. In addition, the process of installing updates of new and improved software versions can be carried out quickly and resource-efficiently in cooperation with the developers of the software solution. Info box: AUVESY GmbH is the software producer behind versiondog, the world's leading version control & data management system for automated production. The versiondog software helps support the needs of customers in GMP regulated sectors during the validation process, especially when it comes to helping them fulfil the requirements placed upon their facilities and systems. Due to the complexity of such facilities and the growing number of software solutions, the demand for assistance in implementing a qualification process has increased sharply. First-hand experience has shown the immense benefit to customers when a software producer—in addition to their research and development activities—is also able to act as a service provider and contribute their product-specific expertise during the course of the qualification process. Authors: Dr. Thorsten Sögding Director Customer Services AUVESY GmbH Georg Seiß M.A. Business Development AUVESY GmbH Copyright AUVESY GmbH · Fichtenstrasse 38 B · 76829 Landau in der Pfalz Date: 04.06.2018 Page 5 of 5

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