Automate Document Control in 72 Hours
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.
Release By ECO
Use Orcanos ECO to manage documents changes and automate documents release in a single batch
Automate self-reading of each released revision and create a training task for each stakeholder
Use Orcanos e-Sign module to build and customize workflow automation and routing of documents or any electronic form
Approved documents are stored and published in a PDF format. Following actions are totally automated:
- Generate a cover letter
- Apply a watermark to each gage
- Sets the previous version to Obsolete with watermark
Orcanos Document Control Software system is a vital part of the process. Companies can 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.
Integrated Design Control and QMS
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.
Automated Revision Control
From setting the revisions to handle obsoletes
Keep a record of any revision uploaded
Automate new revision when a document is signed
Automate obsolete when a new document is released
Automate cover letter and attach it to the published PDF
Set effective date
Distribute new revisions to stakeholders
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.
What our client say about us
"Very good value for money, very helpful with preparations for audits"
Tsvika - System and Software QA Manager Medical Devices
I mainly used it for RISK management, and for PRD SRS and HRS documents requirements, including traceability to RISK. I also used it for Customer Complaints handling
"Using ORCANOS for Medical Devices"
Gerd E - Lead System Architect
One database, one tool and user interface for requirement-, risk-, test-, CAPA-management etc. Item based!!! with the possibility to generate documents on each level. No need to manage interfaces , relatively fast to configure for own needs, without writing and validation of user-ware. 100% cloud based and platform independent.
"My major tool for conformity."
Stephen - QA Manager
The simple and easy way of controlling documentation. Time saving and ease when undergoing audits by Notified Bodies. Traceability when it comes to CAPA and ECO's.
"I love the flexibility of Orcanos!"
I love the flexibility of Orcanos! It feels like the system is almost 100% configurable, so whenever I think 'it would be nice to do this' then I can always do it within the system. The traceability function is awesome too, it means that we can link our items together so that we can get an overview of the project from top to bottom.
"Orcanos gives use Excellent solution"
Linor V - Document Controller
Flexibility, Fit our needs, Fest answer and
Technical Program Manager, Fio
The Orcanos medical ALM solution provides us with a platform to easily deal with complexities entailed in capturing and managing product requirements (system, software, hardware, mechanical, etc.), risks management and traceability in a highly regulated environment.
Co-Founder, Mazor Robotics
Orcanos ALM allows us to build our business strategy KPI’s and see the quality of our processes and the efficiency of our program execution to meet the market demands…
…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…
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Why you choose Orcanos
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FREQUENTLY ASK QUESTION
Want to ask something from us?
Yes, we would be happy to demonstrate Orcanos ALM through a web-conference at your convenience. The demo can take 45-60 minutes depending on your needs. To schedule a session, please contact us at [email protected].
We accept payment via credit cards, PayPal, and bank transfer.
For more details, please contact [email protected]
No. You can to select a package based on your needs (Design Control or QMS), where the Premium package includes EVERYTHING.
It means all users belong to the same package
Orcanos ALM is a pay-as-you-go service (monthly or yearly). This means there are no long-term contracts. You can choose to upgrade, downgrade, or cancel your subscription at any time by logging into your Orcanos ALM account or contact us by email at [email protected].
This is a set of validation documetns (Requirements Spec, Test Design and Tst results) that you get along with our software, and on each upgrade. They are the proof that the software was validated, and that it is Part 11 Compliant
Your data safe and secured. Orcanos is hosted at AWS and apply the strictest security controls. We have a backup procedure running every 15 minutes. Backup snapshot is encrypted and stored on different servers.
Learn more about the Orcanos Security Center
Yes. If you wish to have users that are read only, it’s possible. Contact us for more details
Yes, you can. To switch plans, please contact us.
Yes, it is. You have a full validation package as part of Orcanos system.
No. One of Orcanos’ advantages, is that you have a virtual environment and YOU get to decide if and when to upgrade your account to a newer versions. This is most critical for regulated companies such as medical device manufacturers.