21 CFR Part 11 Compliance Software

A complete quality management and design conrtol software, fully compliant with 21 CFR Part 11

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.

21 CFR Part 11 Requirements support by Orcanos


Electronic records management
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
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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