Increasing complexity and continuous changes in the regulatory environment push organizations to seek a more holistic and highly integrated approach ...
High-content screening (HCS), also known as high-content analysis (HCA) or cellomics, is a method that is used in early development stages and drug discovery to ...
Change management is specifically designed to evaluate, redesign, and implement new business processes, where processes are defined in standard operating procedures ...
To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of of quality management ...
Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures ...
Post implementation training services relate often to process changes. With arivis training services implementations are ready for success. The neuronOS Learning Management System ...
With the development of diagnostic imaging devices, large amounts of digital high-res and 3D images are generated every day. The requirements of effective indexing and searching image ...
The last few years have seen tremendous consolidation in both the pharmaceutical and contract research industries. The impact among pharma companies has created a heightened demand for ...
Imaging data in diagnostics and research is growing at an unprecedented rate, coming from all kinds of sources. The con-focal and high-resolution microscopy, artificial intelligence ...
A clear understanding of how RAW DATA is defined, recorded, and retained in the laboratory record is essential when it comes to compliance with the GLP regulations ...
The management of deviations is not just a GMP concept, it spans the entire product life-cycle, including Good Laboratory Practices (GLP) and Good Clinical Practices ...
To comply with regulatory government policies, clinical research organizations need to keep records of essential documents that are stored in the trial master files (TMF). The TMF allows independent auditors and regulatory authorities to monitor and evaluate the quality of the data produced by a clinical study.
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When there´s no room for error, you must be able to readily access TMF files ...
Read MoreWhy Data Quality and Integrity should be at the heart of your Quality System ...
Read MoreHow an OS in life sciences can drastically decrease inspection preparation time ...
Read MoreThe amount of raw data has increased year by year in drug research and development. New technologies and simply the available storage have created mountains of unstructured data...
Read MoreCreate more value along the life science processes. neuronOS® offers several ready-to-go applications to increase quality, reduce regulatory and financial risks and to leverage innovation and speed.
Read MoreDo you have questions about how to manage your data since the release of the new OECD guidelines?
Read MoreThe broad concept of “biotechnology” or also known as "BioTech" encompasses a wide range of procedures. The global market for the biotechnology market is primarily driven by technologies like DNA sequencing, nano-biotechnology, tissue engineering and regeneration, cell-based assay, PCR technology, and others. Explore the flexible solutions for emerging BioTech
The pharmaceutical industry develops drugs or devices to diagnose, cure, treat or prevent diseases. Pharmaceutical companies produce both generic and branded drugs. Pharmaceutical drugs are subjected to various laws and regulations that deal with patenting, testing, safety, efficacy and marketing. Pharmaceutical drugs are intended for human or veterinary use presented in their finished dosage form. Learn more about the Process excellence of biomedion in Big Pharma.
A contract research organization (CRO) is a company that offers services to the pharmaceutical and biotechnology industries. These companies partner with various companies and organize and conduct clinical trials to test the new molecule before obtaining approval. Contract manufacturing organizations (CMO) offer manufacturing services, with volume capabilities ranging from small amounts for preclinical R&D to larger volumes necessary for clinical trial purposes and commercialization. See how biomedion enables functional service provision with CROs.
A contract manufacturing organization (CMO) is an organization that serves the pharmaceutical industry and provides clients with comprehensive services, from drug development to manufacturing. Outsourcing to a CMO allows the pharmaceutical clients to expand their technical resources, without increased overhead. Arivis offers solid solutions for contract manufacturing.
Third-Party Laboratories for GLP Testing, contract testing laboratories. Pharmaceutical manufacturers contract out any quality control testing, will need a licensed laboratory, certified as a GMP or GLP. The GLP laboratories are designed to protect scientific data integrity, and to provide the EPA or FDA with a clear and auditable record of open-ended research studies. With a biomedion you are committed to integrity with contract testing laboratories.
Microscopes have enabled researchers to conduct in-depth academic and exploratory research. The biomedical research and engineering sector is driving innovation by microscopy techniques to produce better and more informative images of cellular functions, including internal images of cells.
