Shifting from a paper-based and spreadsheet-heavy document management system to a dedicated digital automated solution might seem to be a formidable task, but the integration of an automated DMS can be achieved in no more than 72 hours.
Orcanos DMS has been designed to reduce the time spent onboarding end users in an automated document lifecycle.
Time is often of the essence in the quality process, and the e-DMS covers all aspects of document control. The system ticks all the required boxes, from initiation to approval, distribution and eventual obsolescence.
In keeping with the increased reliance on a digital workflow, Orcanos DMS is compliant with the U.S. FDA’s 21 CFR Part 11 requirements for electronic records and signature.
With document control an important part of the quality journey, the system has the following features:
Approved documents are stored and published in the PDF format. Orcanos DMS will generate a cover letter and apply a watermark to each page. This action makes it more difficult for original documents to be copied or used without permission.
When a new version of a required document is created, the automated system sets the previous version to Obsolete. A new watermark is added to the latest version, which enables end users to both keep track of the current document and ensure that obsolete versions are not printed, saved or copied.
Orcanos Document Control Software system is a vital part of the process. Integration means that companies can now import their entire file system into a central repository with just one click.
Quality-related documents that have been stored on spreadsheets may run into the hundreds, but the system is built to handle the heavy lifting. Once the documents are imported, end users can start working on these resources immediately.
All company stakeholders, whether that is Research and Development, Quality Assurance, Returns Authorization or general management should have minimal barriers to effective Document Control.
Our system combines required elements into a one-stop shop for documents via an integrated Design Control process and a Quality Management System. This single repository gives end users digital access to approved or current documents, CAPA, Change Control, Risk Management, Requirements Managements and a host of other factors that can impact the product lifecycle.
Orcanos DMS is the automated gatekeeper for document revision and ongoing changes. Manual revisions can be time-consuming and accidental errors can slip through the cracks.
The system removes that concern, handling approvals, obsolete documents and effective dates in a single workflow. In addition, relevant project stakeholders will be alerted when any revisions have been made within the DMS.
Dashboards are now the de facto means of accessing and controlling the digital information that we need to execute or analyze a project effectively and efficiently.
Orcanos Document Control Analytics Engine allows companies and end users to build multiple dashboards and panels within the system. This feature enables stakeholders to increase transparency at every stage of the product lifecycle.
After working with the Orcanos team on optimizing our development process, we often get them involved strategically, when we are about to start a new project, or when we assemble a new team. Our experience taught us that it is better to start on the right foot than try to fix things later.
Orcanos Medical ALM Solution provides a platform to easily deal with complexities entailed in capturing and managing product requirements (system, software, hardware, mechanical, etc), risk management and traceability in a highly regulated environment.
Traceability from the cradle to the grave is the key to quality in our development of the most advanced Oncotherapy. Orcanos serves us this tracking ability and gives us high flexibility, comprehensive reports and good office collaboration world wide on top of our existing disjoint systems. This enables us at the AVO-ADAM to live our workflow.
Identify who needs to be part of the document control process, assign roles and permissions for document authors and sign-off
Define and create the document routing process, build workflows and ensure electronic signoff compliance with 21 CFR Part 11
Integrate Orcanos Import tool into standard working practices, transfer your existing document management processes into a single central repository to establish a baseline for end users
All documents require an initial baseline, change management starts here
Combine design control with quality and regulation in a central repository for better collaboration
Easily generate ready for submission documents from your database
Integrating risk into your development ensures that hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971
Define your e-sign processes (routing process) for documents approval, complying with 21 CFR Part 11.
Powerful customization tools to customize your quality forms (CAPA, ECO, non-conformity…), e-sign processes, status flows, mandatory rules and permissions
Build custom reports and charts to track cross-projects/cross-department reports, such as requirements traceability, test run results, risk status, CAPA and more
Link any artifact in your process, such as requirements, to test cases, risk to complaint, CAPA to ECO and track missing traceability
Alerts come into play when process-critical inconsistencies occur, such as new risk or outdated documents. Alerts are automatically fired once a day/week