Let's Combinate · 21 Jun 2023 · 44m
Harsh Thakkar, CEO of Qualtivate, explains how life sciences companies can automate quality management systems (QMS) using no-code tools like Zapier and Make to reduce manual reporting burdens. He details the regulatory framework for software validation, distinguishing between out-of-the-box, configured, and custom software categories defined in GAMP 5. Thakkar emphasizes that validation should focus on intended use and risk rather than validating the entire system, citing the FDA's Computer Software Assurance (CSA) guidance as a way to reduce documentation burdens.
Where this conversation describes AI being used to build or deliver a product. Part of the AI in practice tracker.
Running the companyAccio (AKKIO)
The speaker describes using Accio to upload Excel or CSV files and build custom AI models for data analysis tasks such as spotting trends or learning how events change over time.
“One is called Accio. It's spelled AKKIO. So that's a that's a tool for data analysis. So in the simplest terms, you basically upload an Excel or CSV file and you can build your own AI model using that tool to say, what are you trying to do, right?”
Harsh Thakkar · Hear it at 16:30
Running the companyObviously AI
The speaker mentions using Obviously AI to connect to live data sources like Salesforce or upload files manually to perform trending and tracking analysis.
“And another example in a similar category is a tool called obviously AI, which is very similar. Again, you can connect it to the live data if you are using sales force or any other ERP systems, but you can also manually upload a Excel or CSV file and then do trending and tracking on that.”
Harsh Thakkar · Hear it at 16:30
early-stage companies
Other shows on the same ground, closest first.
Sandra Rodriguez, an analyst at Axendia, discusses the FDA's shift from Computer System Validation (CSV) to Computer Software Assurance (CSA) in medical device manufacturing. She explains how CSA flips the traditional validation pyramid by prioritizing critical thinking and risk assessment over exhaustive documentation, significantly reducing the burden on companies. The conversation covers the industry's response to the September 2022 draft guidance, the role of GAMP 5, and the evolving relationship between life science companies and technology vendors like Greenlight Guru.
Karandeep Singh Badwal, founder of QRA Medical, explains common Quality Management System (QMS) mistakes made by Software as a Medical Device (SaMD) companies, emphasizing that validation must cover all software used in the QMS, not just the device itself. He highlights the frequent failure to treat cloud platforms and software tools like Trello or AWS as controlled suppliers, and the oversight of patient data as customer property. Badwal also stresses the importance of defining deputy roles for key personnel and tailoring procedures to specific jurisdictions like EU MDR and UK regulations.
Sara Adams, a quality engineering expert with extensive experience in FDA inspections, explains why Quality Management Systems (QMS) cannot be bought off-the-shelf, using a sourdough bread analogy to illustrate the need for customization. She details the layers of a QMS, from procedural documents to electronic storage, emphasizing that while tools like Greenlight Guru provide 'guardrails,' the specific procedures must be tailored to the company's risk profile and regulatory requirements. Adams highlights common pitfalls, such as using non-compliant signatures in SharePoint or paper-based systems, and stresses that the ultimate goal of any QMS decision is patient safety, not just passing an audit.
Rob MacCuspie, Manager of Regulatory and Quality Affairs at Proxima Clinical Research, explains how to build a Quality Management System (QMS) by balancing investor cost concerns with FDA regulatory requirements. He argues that a QMS is not just a document management system but a culture driven by management responsibility and people, using a 'highway vs. mountain road' analogy to describe risk-based rigor for different device classes. MacCuspie details the phased implementation of QMS components, the specific challenges of Software as a Medical Device (SaMD) regarding labeling and testing, and the operational efficiency gains of moving from paper to compliant electronic systems like Greenlight Guru.
Kendyl Williams, a Medical Device Guru at Greenlight Guru, details her experience transitioning a medical device company from a paper-based Quality Management System (QMS) to the Greenlight Guru eQMS platform. She describes the logistical failures of the paper system, such as 'document signing parties' and lost binders, and explains how the team validated the new software by locking themselves in a coffee shop to test workflows. Williams highlights the importance of using the sandbox environment to learn the system without risking live data and emphasizes the need for intentional setup regarding document nomenclature and attributes to ensure traceability between risk and design controls.
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