Blog
Agile for GXP and Medtech
These are exciting times to serve the life sciences sector - thanks to technological advances, innovations abound and progress marches on at a lightening-fast clip. Working with a wide variety of organisations, I see two very different types of teams searching for an answer to the same fundamental question: "How do I best do Agile and still comply with regulations?" (For example, ISO-13485, GAMP® 5, etc.) On one side there are traditional pharmaceutical companies. These companies have established ways to create software and have the manpower, capacity, knowledge and procedures to manage...
4 Smart lessons quality managers can squeeze out of a juice bar
If you've ever wandered into a popular juice bar and decided to consume your favorite pressed beverage on-site, you may have noticed a few interesting aspects of the shop's management that resonate with your role as a quality manager: Juice bars are focused on health, as they provide drinks, smoothies and snacks that are full of vitamins, antioxidants and other vital nutrients. The best juice bar managers aren't there solely to collect a paycheck; they are also focused on supporting the wellbeing of the people they serve. Like a juice bar manager, you also seek to improve the health and...
Heading toward hands-free validation
Over the course of working with dozens of innovative, exceptional companies, I'm always struck by their commonalities of purpose and process. While they all are creating products poised to help us all live happier, healthier and more productive lives, ironically enough many tend to put themselves through sadly torturous, inefficient circumstances before their products can see the light of day. And more often then not, the validation cycle is the place where all hell breaks loose. Case in point: One of the biggest and most innovative pharma companies in the world hired us to set up a Jira...
The art of creating complete & accurate records for FDA inspections from Jira
If you need to maintain information for an FDA inspection or submission, Jira is a great tool to use. Be aware, however, that the Code of Federal Regulations Title 21, part 11 requires you to be able to export that data from the system into a readable, precise document: 11.10. (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the...
Agile and design controls: From story to specifications
Doing Agile in a GXP or medical devices environment requires you to serve two masters: you need to practice the Agile disciplines on one side, and embrace regulatory requirements on the other. In order to strike the balance, you must understand the difference between "stories" (Agile term) and "specifications" (Design Controls term). From my experience working with many teams that are "Agile first," I have seen firsthand how easy it is for people to believe that Agile stories are the same as specifications. Not only are they not the same, but also the difference is critical to how you work...
Stuttgart Summit: Highlights & takeaways on how to validate software development tools for GXP and MedDev
Last week a select group of 15 health sector professionals representing businesses from startups to large pharmaceutical companies gathered in Stuttgart, Germany for expert insights on implementing and maintaining effective quality systems. Featuring presentations by four industry leaders, attendees left the conference with actionable information - regardless of if they were initiating a new system or improving an existing one. Given the focus on QMS sustainability and overall efficiency, the presenters illuminated their points with real-world examples of systems that are compliant but not...
How we Saved a medical device company time, compliance headaches and money
For international health industry companies, ensuring regulatory compliance is difficult. Add into the mix an outdated paper-based Quality Management System (QMS), and the task to meet regulatory requirements across multiple locations in an efficient, cost-effective, timely manner becomes impossible – and threatens to derail a busy, successful international organization for non-compliance. The challenge An in vitro diagnostics (IVD) medical device and clinical lab organization with offices in the U.S. and Europe desperately needed a new QMS to better manage a vast quantity of paperwork....
Traceability matrices
Without the right tools in place, traceability matrices can easily bring a project to the brink of collapse. Still today there are project managers who delay moving to production for a significant length of time while they put together a traceability matrix for the validation report. Fortunately, with the addition of appropriate plugins, Jira provides an excellent solution. Using it to manage your specifications and tests will eliminate the need for tedious manual work by integrating traceability throughout every stage of the project. As user requirements and other elements emerge and...
How to validate computerised systems used for GxP and Medical devices environments. Computers system validation in an Agile age
8 February 2018, Stuttgart, Germany (9:00-17:00m)Venue: Milaneo Office Center, Heilbronner Straße 74, Stuttgart, GermanyIn an age where computerised systems make the difference between winning and loosing, we need to find ways to continuously and relentlessly innovate our systems. Today, compliance is no longer enough: we need a validation framework which helps the business move quicker and release often.In this one day conference we will explore the newest trends in computers system validation (CSV). Experts will share perspectives on standards and guidelines for setting up a CSV...
From Paper-Based to practical: How we digitised a paper-based QMS & ensured ISO-27001 compliance in just 5 weeks
An efficient quality management system (QMS) is the lifeblood of any company in the health industry. Failure to meet strict regulatory and compliance requirements could mean lost business or even a complete shutdown of operations. The challenge Biotech start-up SOPHiA GENETICS has had a QMS in place since its launch six years ago. VP of Quality Jasmine Beukema and her team work hard to ensure that SOPHiA has always met the medical device industry’s strict standards. But what began as a six-person company that could easily operate with a paper-based system had since grown to 150. From...