We create all documents necessary for the computer system validation for you or together with you. From the validation plan to the validation report. We have been providing this service to our customers for twenty years - our documents have been used in countless audits. Computer system validation aka CSV enhances the reliability of system, resulting in fewer errors and less risk to process and data integrity.
It is intended to reduce long-term system and project costs by minimizing the cost of maintenance and rework. To achieve such long-term goals, it is necessary to implement processes.
CSV is a critical tool to assure quality of computer system performance. IQ OQ PQ or Installation Qualification, Operational Qualification and Performance Qualification are 3 independent and documented procedures used together to check and test that a mechanical, piping or software system is:
During implementations, biomedion helps customers establish a focused validation methodology that facilitates the adoption of software upgrades while maintaining quality and addressing risk. As a standard part of practice, biomedion supports customers with planning, managing, testing, and preparing for validation. biomedion regularly hosts customer audits upon request.
Test scripts defined in DevOps to cover platform and solution configuration
Automated testing execution for all product updates (regression)
Automatic IQ/OQ execution output deliverables provided
PQ test scripts provided for customer execution
Comprehensive Imaging Science solution for research and production imaging processes. Process support that covers the whole workflow from imaging to conclusions. Improve and integrate image production, data ingestion/archiving, storage, access, analysis strategy, QA/QC, computation at scale, review of results, and implementation of custom algorithms and AI.
Quality Management System with features to secure and control data & documents. Collaborative platform for regulated content, processes and end-to-end compliance along the complete life sciences life cycle. Powerful and intuitive navigation, enhanced user experience, dynamic content management and search features. Connecting quality teams globally.
Trial Master File solution to securely review and audit TMF documentation. Digital process support with form-based workflow for the complete (pre-) clinical document processes. Visualize real-time completeness based on study, country and site indicators. Apply filters and different dimensions, view metadata to intuitively navigate through complex eTMF filings
Document and project management solution for life science. Tools for operations and oversight teams to prepare and review documents and records for the completion and successful submissions and correspondence. User centric collaboration, automation and quality workflows featuring the life cycle of documents and dossiers from authoring to (re-) submission.
BM-Watcher is a 21 CFR Part 11 raw data management solution for the pharmaceutical industry. It integrates with nearly all types of laboratory instruments. It is able to provide data integrity features even for legacy systems. BM-Watcher is an agent that is able to monitor the file storage of a laboratory device.
Complete document management, training management, CAPA, deviations, change control - all in one tool.
BM-Watcher is a 21 CFR Part 11 raw data management solution for the pharmaceutical industry. It integrates with nearly all types of laboratory instruments. It is able to provide data integrity features even for legacy systems.
Modular software toolkit for extracting results from scientific images. Adjusts to hardware for maximum power and smooth interactivity on image datasets of unlimited size. Brings diverse tools into one environment and enables users to connect them into productive workflows. Highly interactive for optimization and quality at every step. Extendible directly via Python and connectable to other applications via libraries.
Display real image data in Virtual Reality by utilizing patent pending direct volume rendering techniques with no need to convert data or make surface models. Directly use your hands to move, rotate, scale, and shape your digital image data. Interactively proofread, edit, track or segment multi-dimensional images from nearly any source instrument.
A nucleus of computational activity and collaboration at scale. VisionHub enables design and execution of large-scale experiments that produce results from images, whether datasets are already stored or are actively being produced. Mass quantities of Imagery are onboarded and processed by a virtual team of computational workers. Smartly utilize processing cores in servers or workstations with the maximum speeds possible.
We offer a variety of different services to help our customers with many aspects of the drug development process and document organization.
Full support for building and improving your organization’s imaging competency. We help you improve any part of the process from acquisition to image management.
Process design and improvement for screening that runs with optimal efficiency. We can integrate AI and ML into your imaging science workflows or help you implement them as effective process steps within other imaging infrastructures.
Extraction of results from images of any kind. We use our years of experience in image computing to help you get the best results as quickly as possible.