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BM-Flow

 

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.

 

21-CFR-part-11icon-auditicon-compliance

 

  • Document creation and editing
  • Document verification and approval
  • Document protection and monitoring
  • Print control and print functions
  • Appendices and references
  • Overview and search functions
  • Training Management
  • Process Designer
  • Form Designer
  • Process Control
  • Search and Reporting
  • Web client
  • Archiving

Fully Integrated Solution

BM-Flow-Mockup
BM-Flow

Quality Management System

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.

 

BM-Flow-screenshot

 

BM-Flow

Controlled Document Management

arivis BM-Flow offers a manageable solution for every company size, which proves itself in operational use and at the same time fulfils the requirements of the local and international regulatory authorities.
arivis BM-Flow supports the complete approval process of a document from the first draft to publication. Users can create and edit drafts with Microsoft Office products or other tools. The documents are then automatically converted into PDF format, which authors, reviewers and approvers sign using electronic signatures. The use of the PDF standard guarantees the long-term availability of the generated files
  • Digital Signatures (no third-party tools required!)
  • Controlled Printing
  • Integrates seamlessly with training management module
  • Long-term archive
BM-Flow

Training Management

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.
  • No synchronization with document management module required - always in sync!
  • Training types and type of training verification configurable
  • Training packages simplify induction of new employees
BM-Flow

QA-Workflow

arivis BM-Flow allows you to design your own workflows with the help of a process designer. This enables the definition of own process steps (“states”) and from there steps and roles.
In addition, it is possible to define which users must give their consent so that the next state can take place or which sub-processes (“child processes”) are started automatically during a state. When a user is assigned a task, he becomes the task manager and the task becomes visible to him. The task manager enters his results in the electronic form.
Depending on the configuration, the main task cannot be completed until all sub tasks have been completed. In a CAPA process, for example, measures can be determined and assigned to task owners. The entire process is documented electronically. For this purpose, an audit trail is provided in which all user entries are visible and all statuses of the process are comprehensibly documented.
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.
  • Graphical form designer
  • Graphical workflow designer
  • Graphical report designer
  • Integrates easily with other systems, i.e. for generating choice lists

Who is using BM-Flow?

Typical customers are in the range between 50 and 1000 users. Among our customers are:

  • Pharmaceutical companies (especially CMOs)
  • Biotech companies
  • GLP laboratories
  • CROs

BM-Flow integrates very easily in existing IT environments, i.e. with SAP, Microsoft Dynamics NAV, LIMS or ELN.

Related Processes

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Audit Management

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.

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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. 

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Change Control

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. 

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Deviations Management

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.

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High Content Screening

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. 

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Image Annotation

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. 

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CRO Collaboration

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. 

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Remote Image Analysis

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. 

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Inspection Management

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).

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SOP Management

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.

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Raw Data Management

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. 

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Training Management

Post implementation training services relate often to process changes. With arivis training services implementations are ready for success. The arivis5D Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations. 

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eTMF and Archiving
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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