FDA 21 CFR Part 11
To assure our customers of compliance with 21 CFR Part 11, CyberMetrics voluntarily undergoes independent third-party audit, review and certification. This includes actual on-site inspection of our records, product development practices, testing methods, maintenance procedures as well as specific functional assessment of our software. Copies of our compliance certification letters are available upon request.
The 21 CFR Part 11-compliant version of FaciliWorks permanently and automatically enables security and the Electronic Signature, Advanced Audit Log and Login Timeout functions.
Security: With security enabled, a user’s access to forms can be limited; for instance, a user can view the Labor form under Work Orders but cannot view the Cost field in that form. To make security easier to implement, you can create groups with standardized access privileges and assign users to groups as needed.
Electronic Signatures and Approvals: The 21 CFR Part 11-compliant version of FaciliWorks records signatures and approval signatures upon the completion of PMs, work orders, service requests and checklists and the creation of purchase orders. Once a record has been signed, it cannot be modified unless the original signer unsigns it. If the record has been approved, the original approver must first unsign the approval record and then the original signer may unsign the record. FaciliWorks maintains a comprehensive history of all signatures on a given record, including date, time, signer and any comments entered at the time the record was signed or unsigned.
Audit Trail: The 21 CFR Part 11-compliant version of FaciliWorks automatically enables and indefinitely preserves the Audit Trail which maintains a comprehensive history of all user actions such as record modifications, additions or deletions along with the date and time of each action and the name of the user who performed the action. The Audit Log can be viewed on screen or printed and can be filtered to show specific records.
The primary objective of this international standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this international standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. FaciliWorks will help you manage your preventative maintenance program and assist you in maintaining compliance with the following sections of the ISO 13485:2016 standard:
- 6.3 Infrastructure
- 7.5.6 Validation of processes for production and service provision
- 7.6 Control of monitoring and measuring devices equipment
- 8.5.2 Corrective action
- 8.5.3 Preventative action
AS9100 replaces the earlier AS9000 and the current revision (Revision D), includes the full text of the ISO 9001:2015, ensuring that the structure of the aviation, space and defense requirements align with the structure of ISO 9001:2015. FaciliWorks has been specifically designed to help you maintain compliance with the relevant sections of ISO 9001 and the AS9100 standards.