Industries regulated by the Food and Drug Administration (FDA) are required to keep records. In 1997, the FDA adopted 21 CFR part 11 which allows those records to be created and maintained electronically. Electronically maintaining records is cost effective and can speed up the FDA approval process. 21 CFR 11 compliance software ensures that electronic records and electronic signatures are considered equivalent to and as trustworthy, reliable, verifiable, and traceable as paper records. 21 CFR part 11 software must meet requirements listed by the FDA for the electronic documents to be considered equivalent to paper documents. If records are kept electronically, but the software used does not meet the FDA requirements, the company is not in compliance and can be cited for violating FDA regulations. When 21 CFR 11 software is used, a company can be assured that 21 CFR part 11 compliance has been attained.
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- User Access Settings: SOPHISTICATED ACCESS RESTRICTIONS: Including both record and field level can be based on groups, departments, personalities and/or employees
- Audit Trails: AssurX automatically maintains a secure, time-stamped compliant audit trail of all changes made to any electronic record; Records and changes are displayed together in their entirety
- Electronic Signature: Once added to a specific record, signatures cannot be modified, copied, transferred, or deleted. Signatures can be of various types (approval, acknowledgement, etc.) and
comments may be included with each.
- Application Compliance: AssurX provides an open integration interface that delivers robust, flexible interaction with any of your existing information systems and databases
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- User Access Settings: Administrator access level can be defined to set up security; Send records with different access control rules to separate archives for purging or classification; Information access is controlled by a username, ID, password, form, form section, field and workflow
- Audit Trails: Audit Trail can be enabled for specific phases or specific fields, can be saved in MS Excel Spreadsheet, and includes user name and ID, date and time, record phase (reason for change), old data, new data, and comments; Configuration Management, changes to user accounts, and changes to field values are tracked in audit trail
- Electronic Signature: Electronic Signature (21 CFR Part 11) consists of user name, date and time, time zone, and meaning of the signature (i.e. record phase, name of activity, etc)
- Application Compliance: Software makes entire system compliant
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- User Access Settings: Multiple access levels
- Audit Trails: The ExcelSafe Audit trail is fully compliant with 21 CFR 11.10e
- Electronic Signature: Electronic signatures meet all requirements of 21 CFR 11, subpart B
- Application Compliance: Software makes Excel Compliant
- User Access Settings: Users can be added to or removed from a security group with a single click. Administrators can also create new users, reset passwords or remove users from the system
- Audit Trails: The Part 11 Toolkit Audit trail is fully compliant with 21 CFR 11.10e
- Electronic Signature: Electronic signatures meet all requirements of 21 CFR 11, subpart B
- Application Compliance: Software makes Access compliant
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