Most (we’d even venture to say all) life sciences companies know that quality is both a safety and a business prerequisite. Quality is the true foundation of our industry. It’s what allows us to trust the data, the science, and ultimately, the impact of what’s produced.
But there’s a catch.
Many companies – especially startups and smaller biopharmas and their partners – still manage quality with spreadsheets or even paper. Yes, spreadsheets are electronic, but they require manual input… and that’s a problem. If you’ve ever managed data in a program like Microsoft Excel, you know manual input is time-consuming, increases the risk of mistakes, and is destined to become unwieldy as needs grow. And don’t even get us started on the lack of version control. When you’re dealing with dozens of spreadsheets stored in different ways across every department, it’s nearly impossible to ensure everyone’s on the same (and most up-to-date) page.
This is especially true when using spreadsheets to keep training materials in a state of control. For five employees, spreadsheets might be doable (although not advised), but for 100 employees and thousands of training records, that’s when the troubles – and the headaches – start.
The Intelligent Quality Maturity Model
Prioritizing quality isn’t just swapping spreadsheets for any basic QMS. Effective quality management goes beyond software and systems, and instead focuses on creating an intelligent quality mindset.
The intelligent quality maturity model helps organizations evaluate their current state of quality and acts as a road map for building a quality-driven culture. It challenges the way we think about people, processes, and technology, emphasizing accountability, automation, and confident compliance.
While the shift from manual to digital moves quality management from reactive to proactive, true business success happens in the next step: intelligent quality management.
Here’s how the manual, proactive, and intelligent quality management approaches compare:
| Manual | Proactive | Intelligent | |
| People | - Low accountability - Reactive mindset - Disconnected KPIs |
- Quality team - Shared quality responsibility - Compliance preparedness |
- Real-time KPIs - Executive champions - Compliant culture - Staff knowledge of SOPs |
| Process | - Failed audits - Time-consuming inquiries - Poorly defined SOPs |
- Defined SOPs and workflows - Advance audit preparation - Clear document lifecycle - Managed training |
- Defined and engaged processes - Automated document lifecycle - Global standardization - Continuous improvement |
| Technology | - Paper or spreadsheets - Local access only - Manual workflows and signatures |
- Compliant e-signatures - Compliant training system |
- Dashboards - Automated workflows - Business intelligence and reporting - Simple administration |
Improved safety and trust are two of the most important outcomes from the intelligent quality maturity model, but the benefits reach the bottom line too. Automating core tasks and eliminating mistakes help businesses get to market faster and more cost-effectively.
But don’t just take our word for it. See how other businesses adopted the intelligent quality maturity model, the impact they felt, and insights on how you can make the switch in our white paper, Intelligent Quality Maturity: Driving Business Success.