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21 CFR Part 11 compliance is required by any medical device companies that wish to sell their devices in the US and EU.
21 CFR Part 11 is the part of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
There is the “Paper” way, and there is the “Electronic” way. In order to comply with the 21 CFR Part 11, the software system must comply with a list of requirements. Orcnaos stands for all of these requirements and allows medical device manufacturers to use it’s software freely and dispose of any paper-based system they have.
Electronic records management
Orcancos ALM system provides a single data repository that combines research and development, quality management and compliance regulations. This means that companies can manage all required elements – testing, risk management, CAPA, change management et al - in one place.
- Electronic records data validation before insertion, such as numeric/dates
- Export electronic records to Excel/Word/HTML
- Save electronic records changes to history table (who/when/why/what)
- A signed record cannot be changed
Electronic signature
- Electronic signature contains all required meta-data such as date/time, user name, role and more
- Electronic signatures contain signing information.
- Electronic signature date & time stamps are outside of the control of the person signing.
- Orcanos requires that no two individuals have the same electronic signature account QPack Hides electronic signature combination
Security
Orcanos restricts logical access to the system to authorized individuals by managing roles and permissions by using User Groups, import groups between projects
- Encrypted Passwords, password format, length, expiry, minimum length
- No two individuals have the same user access account
- Ability to de-activate any account not used for a selected period
- Encrypted Passwords, password minimum length, password aging
- Close session after a specified inactivity period
- User access to data files can only be done through the system’s logical security structure
Audit Trail
Orcanos allows producing visual displays of audit trails of electronic record data and their associated metadata to XML, HTML, Excel, MSWord
- Output data electronically to a file or files such audit trails
- Audit trail records changes to user access levels and privileges
- Audit trail records any events that create, modify or delete electronic records.
- All audit trail entries are computer generated with the date, local time (hr, min, sec), and operator name.
- Log the “reason for the change” as part of the audit trail
- The audit trail keeps all entries for original, modified and deleted records
- All audit trail entries are linked to the associated electronic record of the changed QPack object
- Orcanos users are unable to alter the audit trail
Backup & Archive
Orcanos cloud provides a consistent backup service for all electronic data in a secure way
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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 documents (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.
