GAGEtrak Standards Compliance
By enforcing systematic, adaptable and auditable record keeping, GAGEtrak promotes and maintains compliance with worldwide quality standards. Compliance with these standards set by government agencies and international standards agencies such as ISO, AS, FDA and others is an important element in manufacturing, process and service organizations. With our commitment to compliance assurance, it’s no wonder that over 15,000 organizations worldwide use our software applications in virtually every type of industry and organization.
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FDA 21 CFR Part 11
21 CFR Part 11 sets forth the FDA’s standard for electronic signatures and tracking of all changes to your database. Companies that wish to have electronic records and electronic signatures accepted as equivalent to the corresponding paper records must comply with this standard.
To assure our customers of compliance with 21 CFR Part 11, CyberMetrics voluntarily undergoes independent 3rd party audit, review and certification. This includes actual on-site inspection of our records, product development practices, testing methods, maintenance procedure 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 GAGEtrak permanently and automatically enables security and the Electronic Signature and Audit Trail features.
Security: With security enabled, a user’s access to forms can be limited; for instance, a user can have read-only access in Gage Entry (or no access at all), but can have full access to Calibration Entry in order to create calibration records. 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 GAGEtrak records signatures and approval signatures when calibrations are completed. 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. GAGEtrak maintains a comprehensive history of all signatures on a given record, including date, time and signer. If the record has been unsigned, that information is recorded as well.
Audit Trail: The 21 CFR Part 11-compliant version of GAGEtrak 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.
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The ISO 9000 family of international quality management standards and guidelines has earned a global reputation as the basis for establishing quality management systems. GAGEtrak has been specifically designed to help you gain control of your calibration management system and to assist you in maintaining compliance with the relevant sections of the ISO 9001:2015 standard.
- 7.1.5 Monitoring and Measuring Resources
IATF 16949:2016 (replacing the ISO/TS 16949:2009) is aligned with and refers to the most recent version of ISO’s quality management systems standard, ISO 9001:2015, fully respecting its structure and requirements. IATF 16949:2016 is not a standalone quality management standard, but is implemented as a supplement to, and in conjunction with, ISO 9001:2015. GAGEtrak has been specifically designed to help you gain control of your calibration management system and to assist you in maintaining compliance with the relevant sections of the ISO 9001 and IATF 16949:2016 standards.
This international standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
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. GAGEtrak has been specifically designed to help you gain control of your calibration management system and to assist you in maintaining compliance with the relevant sections of the ISO 9001 and ISO 13485 standards.
- 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
This international standard is for use by laboratories in developing their quality, administrative and technical systems that govern their operations. Laboratory clients, regulatory authorities and accreditation bodies such as A2LA may also use it in conforming or recognizing the competence of laboratories. GAGEtrak has been specifically designed to help you gain control of your calibration management system and to assist you in maintaining compliance with the relevant sections of the ISO 9001 and ISO/IEC 17025 standards. Specific definitions of the ISO/IEC 17025:2017 where GAGEtrak or supporting products can provide compliance are:
- 6.4 Equipment
- 6.5 Metrological traceability
- 7.4 Handling of test or calibration items
- 7.5 Technical records
- 7.6 Evaluation of measurement uncertainty
- 7.7 Ensuring the validity of results
- 7.8 Reporting of results
- 7.11 Control of data and information management
AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was released in October, 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries.
AS9100 replaces the earlier AS9000 and the current revision (Revision D), includes the full text of the ISO 9001:2015, insuring that the structure of the aviation, space and defense requirements align with the structure of ISO 9001:2015. GAGEtrak has been specifically designed to help you gain control of your calibration management system and to assist you in maintaining compliance with the relevant sections of ISO 9001 and the AS9100 standards.
- 7.1.5 Monitoring and Measuring Resources