Regulatory compliance in the life sciences industry is a state of being in accordance with these prescribed rules and guidelines. There are standards which are set forth by different regulatory bodies on both a national and international level.
The arivis5D Compliance functionalities are facing these challenges and how they are developing over the next years. As the number and complexity of regulatory requirements has increased significantly in recent years, and this trend will continue in the near future. With arivis5D we like to ensure a stable Framework for you daily routine based on a reliable compliance risk architecture. Navigate you compliance as easy as your morning coffee.
With the arivis5D Cloud, based on Microsoft Azure, you will get full cloud security and built-in security tools for advanced threat detection as an alternative to on Premise Solutions. arivis5D will allow you to pay on an as-needed basis and scale up your business easily. Your data will be stored offsite and you are able to collaborate e with Partners an customers easily. Based on the arivis configurations you can start immediately with you applications. The arivis5D Cloud Solutions secure your cloud infrastructure without hardware maintenance costs. Provide visibility and consistent security in your hybrid cloud and multi-cloud environments, supported by comprehensive security controls and integration with existing development and production tools.
If your company or institute decides to keep data on premises because of data security reasons arivis offers various on Premise Solutions. So if you decide to store data located within your in-house servers and use our license models, arivis will help you to maintain your on-premise environments professionally. Our Support will help you with your hardware, software and reduce the risk of a security breach.
Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10.
A variety of agile software development methods and practices have been around for more then twenty years. Following the "agile manifesto" the highest priority in this approach is to satisfy the customer through early and continuous delivery of valuable software. The agile development life cycle embraces changing requirements, even late in development. Agile processes harness change for the sake of the customer’s competitive advantage. Time to market is paramount for research and drug and medical device development.
Displays real 3D image data in Virtual Reality with arivis VR software extensions. Utilize patent pending direct volume rendering techniques with no need to convert data or make surface models. The integrated collaboration module enables users to experience their images in an immersive environment together and work collaboratively around the world on the same dataset to explore data. With arivis VisionVR you can directly use your hands to move, rotate, scale, and shape your digital image data. Freed from being tethered to a mouse, like on a desktop computer and with depth perception equivalent to the real world, a person’s hands are unencumbered to simply reach into the data.
Display real 3D image data in Virtual Reality with arivis VR software extensions. Utilize patent pending direct volume rendering techniques with no need to convert data or make surface models. The integrated collaboration module enables users to experience their images in an immersive environment together and work collaboratively around the world on the same dataset to explore data. With arivis VisionVR you can directly use your hands to move, rotate, scale, and shape your digital image data. Freed from being tethered to a mouse, like on a desktop computer and with depth perception equivalent to the real world, a person’s hands are unencumbered to simply reach into the data.
Given immense pressure on Pharma-, Biotech- and Medical Device markets, Life Scientists must develop innovative new drugs without friction, each with a considerable advantage. Corporations and sponsors face an unprecedented need for speed, consistency, and compliance.
The 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 arivis 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 arivis 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 arivis you are committed to integrity with contract testing laboratories.
Institutions in this industry offer academic and professional courses and confer baccalaureate or graduate degrees. In the US major institutions include public university systems in states such as California, New York, and Texas, and private universities such as New York University, Duke, Harvard, and Johns Hopkins. arivis cultivates long term partnerships in academic research.
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.