Omniscient Neurotechnology (Omni Neuro) delivers software solutions to connect pioneers in neurosurgery, neurology, and neuroscience with subject-specific brain analytics. The early-stage startup builds solutions specific to the needs of neurosurgeons, neurologists, psychiatrists, clinical researchers, and academics that can be easily integrated with existing diagnostic, therapeutic, and surgical workflows.
While Omni Neuro is a relatively small company, the startup employs a globally dispersed workforce with staff members residing in the US, Canada, China, and Australia.
Omni Neuro needed a quality management system (QMS) that could address its document control needs and help them meet their compliance requirements. The company was experiencing challenges in ensuring their processes adhered to FDA submission regulations and were compliant with 21 CFR Part 11 requirements. Omni Neuro was also looking for a solution that would help them with the Medical Device Single Audit Program (MDSAP), which allows medical device manufacturers to be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets (Australia, Brazil, Canada, Japan, and the US).
“The nature of our business requires strict adherence to regulatory requirements. Our existing systems weren’t ideal long-term solutions for document control, and they also created validation challenges for us.” “We needed a scalable long-term solution that would allow us to meet our evolving compliance requirements.”
Director of Quality and Regulatory Affairs
New QMS Selection Criteria: Google-based and Easy to Validate
Since Omni Neuro was on a Google-based IT infrastructure, it was vital that the solution the company selected worked within this environment. It was also important that the new system could be customized to meet its specific needs and requirements and could be easily validated.
“AODocs quickly rose to the top of our list because of its integration with the Google Suite, which simply wasn’t the case with other platforms and solutions we evaluated,” said Henkin. “Our staff is very familiar with the Google stack, so we knew user adoption would be very straight-forward.”
“We immediately recognized the value of AODocs not only to help with our immediate document control and compliance needs, but we also saw how our organization would benefit from its innovative and evolving roadmap,” added Henkin.
Low Code Customization Capabilities and AODocs Support Team Drives Rapid QMS Deployment
Omni Neuro has several unique document control and process requirements, and the ability to quickly customize AODocs for Life Science to meet these needs resulted in an incredibly fast deployment. Within about a month after selecting AODocs, the company was already leveraging the quality management system for audits.
The company quickly configured document libraries and workflows for the management of business-critical documentation such as records, SOPs, training documents, design history files, device master records, user manuals, and more.
“We purchased and began implementing AODocs in April, and by May we were already using the platform to pass an internal audit. The platform was immensely helpful in our July FDA submission, and we also leveraged it for our first external audit in August,” said Henkin.
Omni Neuro customized the majority of the AODocs platform by itself and worked with the AODocs support team to help configure their training and incident management modules.
“Working with the AODocs team was great. Their support staff was instrumental in helping architect our configuration for incident management, which included training request workflows and establishing security and privacy controls. The ability to create our own incident management module has been huge in our ability to pass audits,” noted Henkin.
Seamless QMS Software Validation with AODocs for Life Sciences
Cloud solutions must be validated for life sciences companies to use them, and every time a cloud vendor makes an update to their software, it needs to be re-validated. Unfortunately, many life science firms still conduct validation testing manually, which is time consuming and prone to error.
However, AODocs employs a continuous validation approach for its offerings, which alleviates the headaches typically involved with meeting validation requirements.
“AODocs for Life Sciences was the first system we validated within our environment...Their continuous validation approach saved us a tremendous amount of time and internal resources. Our auditors appreciate that we take IT system changes seriously, and that we mitigate the risks of those changes with a continuous software validation model.”
An Eye Towards the Future
Omni Neuro believes it has just scratched the surface with what the company can accomplish with the modern and innovative AODocs quality management system.
“We’re currently in the beta stage for another AODocs module that will enable us to better manage our corrective and preventative actions (CAPAs) and audits, as well as expand our incident management module as a future service engagement. We’re also looking at integrating the QMS with our product lifecycle management (PLM) and other existing systems,” added Henkin.