No. It’s never too early to think about quality!

As a quality professional in the pharmaceutical and biotechnology industry, people often ask me when early-stage companies should begin thinking about implementing quality systems.

The answer is, “yesterday.”

All kidding aside, early-stage companies should plan on implementing quality systems before they embark on the journey of collecting and contextualizing data in order for it to be used for submission to the relevant regulatory agency or notified body.

• Companies should also make sure they have procedures in place to
• Evaluate and qualify suppliers
• Train the internal team
• Conduct laboratory testing
• Ensure data integrity

Begin the Product Lifecycle Management (PLM) journey - supplier management, risk management, product and process requirements

Remember that a “Quality System” is one way to implement requirements, but it is also regarded as a good business practice.

Companies like Ford, Motorola, and Pfizer don’t implement Quality Systems because they have to, they implement them because it reduces process errors and lowers costs, allowing for optimized yield.

Another overlooked benefit of a quality system for start-ups is its value in conversations with partners and investors. The Quality System is the foundation of your project and ensures that processes and procedures are in place as you navigate through the hurdles of a product’s lifecycle. Investors are looking for companies with good ideas but also those with established processes and solid data to carry these ideas to fruition. A good idea alone is not enough, it needs execution!

A quality system will help early-stage companies answer savvy partners and investors who ask about:

• Training. Were the people who implemented the testing or manufacturing properly trained?
• Data. Is the data reliable? How was the R&D or early phase data collected and reviewed? What variables were evaluated? What is the margin of error? How was risk evaluated and documented?
• Supply Chain. Is the supply chain secure? Are the vendors providing reliable materials and services?
• Process Knowledge. Is there a clear and concise “Recipe” for the product? Can this be duplicated, transferred, or scaled up?
• Speed to Market Predictions. Never forget that an accurate “time to market” depends on doing the work upfront to move efficiently and without undue delay.

Having a documented quality system shows future partners and investors that you are serious, you know what you are doing, and that they should have confidence in the data and results that you are presenting. Many investors will be looking to ensure that you are also thinking ahead as to whether you are prepared for Product Lifecycle Management (PLM) and things like supplier management, risk management, and readiness to implement industry best practices around product and process requirements.

“Okay, Rebecca. You’ve convinced us. Now how do we get started?” Well, it isn’t as daunting as it might seem! A best practice is to draft a basic quality plan when you draft your initial project documents.

A good quality system should be easily understood. It can and should “grow” with your company.

Here is a basic roadmap for kicking off your quality journey:

1. Review your project charter or project plan to determine the type of product you hope to get developed, approved, or marketed.
2. Evaluate the scale and timeline of your project to make sure your quality system meets the business needs of your project.
3. Include regulatory requirements and any guidance specific to your product.
4. Review industry best practices or international standards that you may want to include.
5. Make all employees and contractors stakeholders in the quality system, incorporate it into your daily activities.
6. Leverage a digital QMS, preferably with a training module to support your program, rather than weighing down valuable personnel time with a paper system.
7. Find a solution like QbDVision that offers a digital QMS with additional product lifecycle management functionality, including supplier management, risk management, and establishment of patient and product requirements.
8. Success!