arivis BM-Flow is a 21 CFR Part 11, GxP and ISO 13485 compliant document management system for the pharmaceutical and medical device industry. Since modules for CAPA/deviations and training management are deeply integrated, it is a tool for all document management tasks in QA, manufacturing as well as in the laboratory. In addition to our industry-specific modules, we can also rely on a multitude of tried and tested modules for generic document management purposes.
arivis BM-Flow supplements its BM-Windream system with functions for document control (for example SOPs, batch records, test plans, validation documents and many more) and the management of typical quality management processes (for example deviations, Out-Of-Specification, complaints and others). Thanks to the high degree of integration possible with BM-Flow, you always have an overview of all processes and their interrelationships.
The content of a training course can be selected from a list of BM-Flow module “Managed Documents” or from any other content. One or more training groups can be assigned to each training content. Training needs are generated for the users in these training groups for certain events, e.g. for the approval of a document, for reaching an adjustable deadline, or for the approval of a subsequent version. In addition, training requirements are also generated when new users join a training group. It is also possible to create training needs manually to enable spontaneous training. At least one training manager is assigned to each training group. All training managers can view the training needs of their training area and plan their training accordingly. It is possible to bundle several course contents in one course.
The individual training participants then receive the training contents in the form of self-training or classroom training (presence training). Both types of training are documented using electronic signatures. Alternatively, classroom students can also sign on paper on a printable training certificate. The trainer then signs electronically for the presence of these signatures. It can be configured in the system that the owners of certain roles (e.g. the author and reviewer of a document) are implicitly regarded as trained.
This type of training is displayed in the system accordingly, and no training requirements are generated for the corresponding users. In addition, there may be versions of a document that are not relevant for training. For these versions, successfully trained users of the previous version are also regarded as trained.
At the end of the training, the trainer evaluates the success of each participant’s training. Unsuccessful participants are not documented, but release the demand again until all trainees have been successfully trained.
Of course, an audit trail is kept of all changes made to a training course. Furthermore, it is possible to generate almost any report on the training courses, training contents and individual training statuses.
A special feature is the integration of the electronic signature: this not only allows information of a specific state, but also all information in planned sub-processes. Thus, for example, the member of a QA group can sign a deviation report including all planned activities.
Typical customers are in the range between 50 and 1000 users. Among our customers are:
BM-Flow integrates very easily in existing IT environments, i.e.:
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.