What is your role with PAX-it?
I serve as the President of Midwest Information Systems, (MIS), the makers of PAX-it Image Management and Analysis Software (www.paxit.com) and the PAXcam family of microscope cameras (www.paxcam.com), leading our talented and experienced team of sales, programming, product development, technical support and administrative professionals. I also support the efforts of our key distribution and supplier partners.
What is your background?
After graduating from university, I worked for 20 years at a quality-minded organisation in a completely different industry. I was responsible for operations, service, distribution and design. I also was a project manager / salesperson for many of our key accounts. The experiences and skills I gained in that organisation prepared me well and transferred to my work at MIS.
What made you decide that you wanted to be in the science field?
Through my school years, I always gravitated toward math and the sciences. I took as many courses in chemistry, biology and physics that I was able to, minoring in Chemistry in my university days. I love the environment of curiosity, discovery and precision that is found in laboratories of all different types.
Many of our scientific users have an entrepreneurial spirit that drives innovation within their organisations, so it is a privilege for us to be able to support and enhance their important work. Seth Grotelueschen, the founder and CEO of MIS, had built a successful organisation, since 1988, that was entrepreneurial and innovative as well, so it was a great honour for me to join MIS in 2002.
Where did the idea come from for PAX-it software?
PAX-it Image Management, Measurement and Image Analysis software (www.paxit.com) began and has continued to develop through the years largely because of customer need. In the early years, imaging in laboratories was done on film and measurement and analysis of those images was done manually.
Once computers, modems, networks, analog and digital cameras came along, we had some customers who were interested in transferring images digitally from one location to another. So our team developed a very basic (and expensive!) package to allow images to be shared from one location to another. “PAX”, which stood for “Picture Archival and Transmission (X)” met that initial need. Once a customer could do that, a mystery at the time but commonplace today, they began to ask for increased functionality: the ability to measure the new digitised image, to perform image analysis, to annotate, database and report. So, PAX-it continued to grow.
In the last 10 years, as pharmaceutical regulations have become more demanding, particularly related to the US FDA 21 CFR Part 11 regulation, we created some very tailored and targeted solutions for pharmaceutical imaging, still based on the robust PAX-it core that was being used in thousands of laboratories around the world. Almost every innovation came from real world customer needs and requests, and our team has been able to build an amazing product through the years.
How over the years do you feel that data information has changed?
Data and imaging information has grown exponentially in recent years. Organisations have so much data that they need to manage and analyse in order to grow, increase quality, inspect, document. Data needs to be archived for longer periods of time and must be readily retrieved. The complexities of the data and the demands to present and secure it in order to meet supplier, customer and government demands (21 CFR Part 11 being a good example) require that software solutions are fresh, comprehensive and powerful.
The written reports with images attached, manual measurements and analysis stored in file cabinets and warehouses have given way to sophisticated databases of information that can be accessed and used by all areas of an organisation through computers and networks, intranets and the Internet. Statistical and analytical information is used to manage the business, address government regulations and audits, legal issues, productivity and quality improvement. With all of this information, organizations need a robust software tool to manage all of that imaging, measurement and reporting data in a database that is searchable and flexible. That’s what PAX-it is designed to do.
How do you think this can change the industry?
PAX-it’s Extended Security software, focused primarily on 21 CFR Part 11 compliance, addresses some very specific and narrow requirements of the US FDA, but also must have built-in flexibility to address different processes and practices from one pharma organization to the next. Everyone uses the tools we provide in different ways, while still needing to meet the stringent requirements for the regulation.
Pharmaceutical companies are required to follow these regulations, and PAX-it has a unique position in the market to assist those companies toward compliance; not just the software tools but a comprehensive, self-contained system that helps to reduce human error or manipulation of digital images and assets. We also offer turn-key installation, training and IQ/OQ documentation. PAX-it software and the installation that Mason Technologies and MIS provide is indeed changing the industry.
What goals do you hope to accomplish with PAX-it 21 CFR Part 11 software?
Our goals are simple: to provide the highest quality software solutions, tailored to our customers’ specific needs, and the highest level of service and support. We want to help our customers with their imaging workflow so that they can easily manage and secure their digital assets, use their images to document, measure, analyse and report.
Pharmaceutical organisations need partners to assist with their compliance and imaging management issues. Mason Technology and MIS are the most experienced partners to assist.
What challenges do you feel you face in your industry?
Like every technology organisation, we face the challenge of a rapidly changing market. Needs, markets and opportunities change every day for each of us. In order to thrive and survive, we need to remain close to our customers and partners, listening to their changing needs, and providing them with the new tools they need to thrive and survive. That’s not easy, especially for smaller businesses, and it demands a great team of professionals committed to the success of our organisation and the success of our customers, distributors and partners.
Why did you decide you wanted to work with Mason Technology?
Mason Technology has been a trusted, quality scientific technology company for over 200 years. They have served their customers all over Ireland with distinction and high-level service and expertise. Who wouldn’t want a distributor partner like them? The have particular skill and experience in the challenging pharmaceutical industry, as do we, so the partnership makes perfect sense. We are a great team together.
What do you wish people knew more about with these regulations?
The FDA is serious about 21 CFR Part 11 compliance. In Europe, audits are happening regularly and frequently. It’s not enough to have some software tools to address the key issues of the regulation. The tools must be part of a comprehensive plan, with documented Standard Operating Procedures and secured infrastructures, policies and well-trained users in order to meet audit requirements. Don’t take these issues lightly or you could face some severe penalties and disruption to your business until compliance can be achieved.
Any tips for customers considering PAX-it software or other 21 CFR Part 11 compliance solutions?
We believe that PAX-it 21 CFR Part 11 Module software is the strongest tool, combined with the strongest consultative and integration services, to serve the pharmaceutical market. A professional from Mason Technology and we will be happy to show you the product in action, provide pricing and product information for your consideration. You’ll like what you see!
If you are looking at other solutions, be careful! Ask good questions to make sure that your 21 CFR Part 11 software provider has experience and full-service capabilities to assist with the comprehensive process necessary to work toward compliance. Simply buying some software that has certain tools that are required by the regulation does not ensure that you’ll be compliant. There are many other components required and you’ll want a partner who understands how the software fits into the entire plan.
How do you feel about expanding this software in the UK?
PAX-it software has been serving users in laboratories across the UK since 1999, beginning in the world’s leading pharmaceutical companies. When the FDA’s 21 CFR Part 11 regulation was finalized in 2007, PAX-it software had already developed the tools and structure to become the leader in compliance software. We had opportunities to reintroduce our new product into existing accounts as well as into new ventures in the UK. We are extremely excited about partnering with Mason Technology, a proven technology and service provider in Ireland, to continue to help UK customers with all of their optical and software needs in the years ahead.