Standards Compliance

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 is 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 is 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 is 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 is 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 is 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

This standard has been created by the SAE G-22 Aerospace Engine Supplier Quality (AESQ) Technical Committee to harmonize and simplify supplier quality requirements that are in addition to the requirements of 9100 Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations and 9145 Advanced Product Quality Planning and Production Part Approval Process.

Previously the Aerospace Engine Manufacturers based their supplier quality requirements on 9100 but had differing supplemental requirements and guidance albeit with largely the same intent. These supplemental requirements originate from the need to meet Regulatory, Customer, Industry, and Business requirements that are not explicitly covered by 9100 and 9145. This standard sets out to create a common set of supplemental requirements with common reference materials to improve understanding, efficiency, and performance.

GAGEtrak is specifically designed to help you gain control of your calibration management system and to assist you in maintaining compliance with the relevant sections of AS9100 and AS13100 supplemental standards.

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 is signed, it cannot be modified unless the original signer unsigns it. If the record is 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. The unsigning of records 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. You can either view the Audit Log onscreen or print it and you can filter the Audit Log to show specific records.

Streamline the validation process! Click here for information about the GAGEtrak Validation Kit and our onsite validation services.

For organizations seeking to act in accordance with the Federal Information Security Management Act of 2002 (FISMA) and the Federal Information Security Modernization Act of 2014 (FISMA2014), you must adhere to the various data security and computer system standards outlined in the Federal Information Processing Standards (FIPS). GAGEtrak has been developed within the Microsoft .NET technology stack, utilizing modern, FIPS-approved algorithms. Therefore, you can be assured that GAGEtrak will install and run in your FIPS-enabled Windows environments.