In 2022, Yunu approached RookQS with the goal of achieving 21 CFR Part 11 compliance for electronic records and signatures within their medical imaging platform used for research purposes.
Yunu is a developer of a software composed of a secure imaging portal that allows for clinical trial workflow management between physicians and researchers to reform imaging in the clinical trials field.
Yunu’s software development efforts utilize the Agile methodology and are led by research and development, AI, and medical imaging experts with a collective 90 years of imaging innovation experience.
Scope of Work
Yunu requested that RookQS collaborate with their internal software development team to ensure the integration of 21 CFR Part 11 requirements for electronic records and signatures with their existing medical imaging platform. Yunu also requested that RookQS provide feedback on the medical imaging platform’s existing software development and risk documentation and recommend pathways towards any necessary remediation actions.
The RookQS team devised a plan that prioritized establishing design controls to ensure the proper definition, verification, and validation of the software’s electronic signature capabilities against 21 CFR Part 11. The primary phases of this strategy consisted of:
- Establishment of a project timeline, implementation strategy, and weekly meetings between RQS and Yunu’s software development team.
- Collaborative sessions to familiarize RQS with the SaMD platform and identify unmet 21 CFR Part 11 requirements.
- Integrating the necessary design controls to demonstrate software compliance to 21 CFR Part 11 requirements, including requirements, specifications, verification protocols, and validation plans/reports.
Establishing design controls was the first step in the implementation strategy, with the initial focus being to identify key inputs that would meet the specific requirements.
21 CFR Part 11 identifies 5 main areas of electronic records and signatures:
- Audit Trail
- Legacy Systems
- Copies of Records
- Record Retention
Once software requirement specifications for these five areas were established, a gap analysis was conducted to determine which of the new requirements were addressed by existing design controls and to determine the additional specifications, verifications, and validations necessary to provide evidence of meeting the 21 CFR Part 11 requirements for electronic signatures and records.
The gap analysis involved Yunu providing their software documentation and access to their software to RookQS for review. Frequent collaboration with Yunu’s software development team allowed for the remediation of each gap within the software documentation and the implementation of the remediations within the source code.
Following the establishment of the revised software requirement specifications and software detailed specifications, Yunu’s software development team implemented the software changes within the source code to address each gap. RQS concurrently drafted validation protocols that would ensure the safe and effective use of Yunu’s medical imaging platform in accordance with its intended use.
Throughout the gap analysis and remediation actions, Yunu became aware of the issues within their current QMS documentation system. RookQS recommended Greenlight Guru as an electronic QMS (eQMS) which would reduce the effort involved in creating and publishing QMS records, provide additional traceability between their software design and risk controls, and ensure automated revision history of all QMS documentation. RookQS was able to successfully transition Yunu’s current QMS and software documentation to Greenlight Guru, with no impact to Yunu’s software development efforts.
Yunu’s software development team followed RookQS’ recommendations, and was able to integrate 21 CFR Part 11 compliance for electronic signatures and records within their medical imaging platform. Additionally, RookQS was able to transition Yunu’s existing QMS to Greenlight Guru’s eQMS platform.
“As a small team with little compliance experience, we leaned on the expertise of RookQS for our 21 CFR Part 11 project. The team led by Michael Chen was responsive, informative, and drove the project forward with a well-documented plan. Because of this we were able to meet all of our goals within the narrow timespan of a few months.” – James Hank, Customer Success Technical Manager, Yunu