The day that a pharmaceutical company or medical device manufacturer receives approval by the authorities for its medicinal product is typically a joyous one. However, the work to ensure a successful product launch is just beginning. The day after FDA approval is a busy one for medical affairs, pharmacovigilance, and sales reps, product supplies and logistic centers.
With a new product available for patients, pharmaceutical companies follow a complex framework of regulations and protocols to ensure the patients’ absolute safety with the newly approved product. At a time when innovative and complex biologic drugs and devices get in contact with patients, it is even more essential that pharmaceutical corporations, manufactures and healthcare providers follow regulations correctly.
The increasing complexity and continuous changes in the regulatory environment push organizations to seek a more holistic and highly integrated approach to their audit management processes. Auditing is a vital function within a pharmaceutical company.
To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management in GxP environments. The CAPA process is a commonly used tool to achieve operational excellence by identifying and mitigating non-conformances and deviations, both internally and externally.
Change management is specifically designed to evaluate, redesign, and implement new business processes, where processes are defined in standard operating procedures (SOPs). A well implemented change management rewards the company with improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture.
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 (GCP) and Process Deviation Management.
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 typically identify substances such as small molecules, peptides, or relevant RNAi that can lead into development candidates for future medicines.
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 are growing rapidly. Image annotation is an effective way for content-based image retrieval.
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 productivity.
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, and any other new computer-tomographic (CT) technologies create vast amount of data. When researchers start to collaborate over distances with imaging centers, using diagnostic services over internet connections, the bandwidth and computation power easily exceeds the capabilities in remote areas.
Regulatory agencies conduct routine inspections during active studies. In this case, documentation must be available and complete, ensuring that the study was conducted following the protocol using the principles of Good Clinical Practices (GCP).
Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.
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 Good Laboratory Practices regulations. RAW DATA in laboratories occur in various fluctuating formats and versions in a large amount of laboratory devices, LIMS and quality management systems.
Post implementation training services relate often to process changes. With arivis training services implementations are ready for success. The neuronOS Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations.
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.
arivis 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. arivis 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.