Excellence in the various Quality processes is paramount throughout the whole life sciences industry. Medicinal products and devices, which have the potential to drastically change lives, must be developed with frictionless quality systems in place, to ensure controlled documentation and end-to-end compliance at any time. Quality assurance as such is a pretty broad concept. It covers all aspects of your process that can have an impact on patient outcomes.
The risk of not implementing comprehensive quality systems is well documented. The numerous yearly findings of authorities like FDA or EMA can still be devastating to a company with poor performance in quality.
Such findings can lead to substantial costs related to corrective measures, remediation and blocking of sites and product. Companies can face external costs like regulatory action, massive reputational damage, and a loss of market share.
US-based pharmaceutical organizations should work to assess and understand the following regulatory requirements from the Food and Drug Administration (FDA), including clinical requirements:
If your marketing ambitions post-approval include Europe, you should strongly consider aligning your quality system to ICH Q10 earlier in your development.
Constantly verify the consistency of existing processes and whether existing specifications are appropriate and adequate.
GxP - the implementation of quality principles for raw materials, the manufacturing process, packaging, transportation, and storage.
Besides the obvious process excellence, a proper product the quality-driven culture remains a main factor to achieve quality.
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 nowadays CAPA Management
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.
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.
Properly designed Standard Operating Procedures include step-by-step instructions as well as the following:
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 pays back into improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture.
Post implementation training services often relateto process changes. With biomedion 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.
As a common mechanism to discriminate events based on their relevance and to objectively categorize them, concentrating resources and efforts in good quality investigations of the root causes of relevant deviations.
Audits, safety inspections, engineering surveys, and quality checks are common in life sciences. While they add overheads, they are necessary to keep organizations in business.
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.