Orcanos Document Management Software System Imports, Approve, Distribute and Archive your FDA controlled documents
Orcanos Document Management Software, 21 CFR Part 11 compliant, is an integrated module of Orcanos Medical e-QMS cloud solution.
Orcanos Document Management Software enables you to quickly create, archive, trace, search and audit all documentation related to the planning, design, development, manufacturing and service of a medical device product. Setup any document type with Orcanos e-DMS Electronic Forms Builder, such as work instructions, forms, manuals, procedures, product specifications, inspections, test procedures, and more.
Orcanos Document Management Software system import tool allows importing your entire file system into Orcanos central repository, in just a few clicks.
You can then custom your document meta-data, define routing processes, and start your electronic signature.
Documents Versioning ensures people are working on the latest released versions, with rollback ability as a safeguard. Publication control allows you to define distribution list decide when to publish and to whom.
By automating routing process and approvals, and using Orcanos Part 11 electronic signature mechanism, you can reduce your document approval cycle time.
Orcanos flexible approval process allows you to define signers, signer order, alternate signers and more
Orcanos e-DMS Supports parallel and sequential routing process to avoid bottle necks
Organize and manage the big volume of documents using hierarchic folders and classification.
Use Orcanos traceability tool in order to link documents for impact analysis
Folders allow hierarchical organization of documents, same as Windows Explorer, but using Orcanos e-DMS Copy As Link feature allows arrangeing each document under multiple folders.
This powerful feature allows managing several DHF structures, sharing documents among them
Automate document approval process, from creation to sign-off, distribution, retrieval, and obsolescence, while reducing document cycle time. By defining a streamlined and standardized routing process, you can assure easy adoption of all stakeholders to participate in the process.
Orcanos Document Management Software tracking tools allow tracking and automatic alerts for each state in the current workflow.
Administrators can quickly create, manage, import/export routing processes models with sophisticated events and processes, where any number of tasks can be executed in parallel or serial sequences of steps. Alternate users can be assigned to each task, and with the escalation management, ORCANOS e-DMS will take care of notifying the users to complete their work.
On document approval, an effective date is set to the document, and previous document revision becomes obsolete
Help your employees save time by finding the right information exactly when it’s needed. Empower your teams to share, access, enrich, and store high-quality content in a single place. QPack Document Management Software can manage all of your organization’s documents and valuable intelligence in a secure archive that spans the entire company. Create, distribute, and improve records within team collaborative workspaces while ensuring proper approval and reviews with positive workflow.
Easy setup your document meta-data layout along with custom queries, allows Users to access files and their associated metadata easily
Publish Word documents to PDF subsequent to the document sign-off, with an embedded cover letter with the electronic signature details, enables users to preclude unauthorized printing, saving or copying of the documentation.
Once document is approved, and new revision is set, former revision becomes obsolete, with watermark
After working with Orcanos 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 it later
ORCANOS Medical ALM Solution provided a platform to easily deal with complexities entailed in capturing and managing of Product Requirements (System, Software, Hardware, Mechanical, etc) , Risks 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’s……..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
Regulated organizations struggle to keep pace with the ever-increasing number of documents, flooding into the organization. A flexible Document Management Softwaree System improves efficiancy, saves time an reduce risk in the audit events dramatically.
Document management software system is also an important aspect of medical device manufacturing and post-market maintenance processes such as complaints, CAPA and ECO. Regulatory authorities mandate that all devices must include traceable documentation such as a design history file (DHF) for the entire lifetime of a product. In the event of a defect or recall, the related documents can be quickly retrieved, such as verification and validation documents.