21 CFR Part 11 Compliance Software

Orcanos is a complete quality management and design control software, fully compliant with 21 CFR Part 11/Annex 11.

21 CFR Part 11/Annex 11 compliance

21 CFR Part 11/Annex 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. Orcanos stands for all of these requirements and allows medical device manufacturers to use its software freely and dispose of any paper-based system they have.

Electronic records management

Ensure compliance with 21 CFR Part 11 regulations and streamline your medical device development process with Orcanos. Our intuitive solution empowers you to meet the necessary requirements for selling devices in the US and EU. Simplify compliance with features designed to meet FDA guidelines, including electronic signatures, audit trails, and user authentication. Discover how Orcanos can help your organization achieve 21 CFR Part 11 compliance today.

Electronic records data validation before insertion, such as numeric/dates
Export electronic records to Excel/Word/HTML
Save electronic records changes to history table
A signed record cannot be changed

Electronic signature

You can easily sign all your electronic records and documents with Orcanos' Electronic Signature.

Electronic signature contains all required meta-data such as date/time, user name, and role.
Electronic signatures contain all required signing information.
Electronic signature date & time stamps are outside of the control of the person signing.
Orcanos mandates that each individual must have a unique electronic signature account.

Security

At Orcanos, logical accounts are restricted to authorized personnel who have been granted system access. This is managed through role-based permissions, which are assigned by user groups.

Encrypted Passwords, password format, length, expiry, minimum length.
Signing using Single Sign On (SSO) to authenticate against your company identity provider.
Ability to de-activate any account not used for a selected period
Close session after a specified inactivity period

Take your regulatory compliance to the next level with Orcanos. Book a demo today and experience the power of our integrated solutions firsthand!

Audit Trail

Orcanos allows producing visual displays of audit trails of electronic record data and their associated metadata to XML, HTML, Excel, MSWord.

Audit trail records any events that create, modify or delete electronic records.
Output data electronically to a file or files such audit trails.
Audit trail records changes to user access levels and privileges.
All audit trail entries are computer generated with the date, local time (hour, 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 object.
Orcanos users are unable to alter the audit trail.

Backup & Archive

Orcanos Cloud guarantees a reliable and secure backup service for all electronic data and documents.