Our laboratory software for use in regulated environments
Both compliant and flexible
In the pharmaceutical and medical technology industry, which is regulated by special legal requirements, strict demands are placed on the quality assurance and documentation of projects and realisations. A great deal of effort is put into ensuring consistent, high quality in the pharmaceutical manufacturing process. Without the so-called computerised systems, this would no longer be possible today.
Our diaLIMS supports you in complying with the GxP quality rules:
Stability, processing speed, data integrity, traceability
Feature overview
- Stability controls
- Warehouse management
- Documentation modules (SOPs, DMS, protocols)
- Electronic signatures
- (Validation) project management
- Change management & activities
- Audit trail & audit trail review
- Comprehensive authorisation concept
- Release management
- DIN EN ISO 17025 compliant test reports
Validation
In addition to the functional requirements for a computerised system, the validation of the system through a validation project is also mandatory.
A system is always validated in the environment in which it is used and only for processes that directly affect the pharmaceutical manufacturing process.
Take advantage of our expertise and our services to minimise the validation effort.
Software category S4 for your laboratory system
In GAMP 5, software is divided into four categories.
Our diaLIMS can be classified as category 4 - configurable standard software.
What does this mean for you?
- Design and functional specifications are simplified by the need for a simplified configuration specification.
- Separate module or element tests are no longer necessary.
- Documented code review only for individually programmed extensions.
Comprehensive quality assurance
Our system is subject to strict quality control.
Our quality assurance department works daily to identify errors before they reach a customer environment.
You also benefit from our test plans and test protocols for your own validation documentation. Large parts of the standard functionalities are also tested daily using automated unit tests in order to identify errors even more quickly.
Further documentation
In addition to the test plans and test protocols already mentioned, other validation documents can also be created or jointly developed during the course of the project, such as
- Installation documentation (IQ)
- Training documents
- Process test plans & process documentation
- User Requirement Specification (URS)
Data integrity
Data integrity is one of the most central issues when it comes to computerised systems. For us, it is a matter of course to ensure integrity throughout the entire data life cycle.
We adhere to the data integrity criteria according to ALCOA+.
Read more about how you can comply with the principles of data integrity according to ALCOA+ with diaLIMS.
Would you like to find out more about our solutions for the regulated environment and other topics in diaLIMS?
Send us an enquiry using our contact form and our customer service team will get in touch with you shortly.
We would be happy to visit you at your premises and present our software solution for your company.
A remote presentation is also possible without any problems.