Watchmaker Genomics specializes in the protein engineering and enzyme manufacturing sector.
Watchmaker was founded in 2019 and provides precision tools for genomic, molecular diagnostic and synthetic biological applications, including next-generation sequencing (NGS) amplification kits and DNA/RNA prep kits.
As a manufacturer of these products, Watchmaker has ISO 13485 accreditation as a core quality and compliance objective.
Watchmaker's products are used in CAP/CLIA laboratories for sample analysis and so airtight product quality is vital.
After establishing several other companies in the past, Watchmaker Genomics' CEO Trey Foskett was conscious of the significance and business impact of implementing a digital quality approach early, rather than waiting too long and 'tacking on' quality to pre-existing processes.
Trey's learnings were to implement an eQMS earlier than he'd done in the past.
That's why it was such a big focus and one of the first major projects we did as a business.
The business was therefore keen to quickly establish a single, central mechanism for managing quality, from accessing day-to-day information and documenting work to accessing rich quality data and being able to quickly and nimbly respond to defects with controlled CAPA plans.
Quality Control Manager Skyler Mishkin was tasked with sourcing the best possible electronic quality management system (eQMS), and the company began the search within the first few months of establishment.
It's more than just my job and about having a team that does quality.
It's about having everyone understand what quality means, having access to their work instructions, having a clean and straightforward way to do their jobs - whether that's someone in production or QA.
Skyler and his team chose Qualio as the eQMS vendor of choice, a decision which Director of Quality Assurance Peter Bruesehoff reviewed when he joined the business a year later.
Peter found not only a well-established eQMS that the business comfortably engaged with, but a strong partner relationship with Qualio and a balanced approach between meeting complex quality needs and overly burdensome customization and validation.
I found that Qualio was meeting the company's needs without needing to be customized too deeply and getting into super-intense validation.
There was also such a strong relationship. I've worked with companies where I've said, "it'd be nice to have this feature", and they've replied that it'll need deep customization and massive amounts of money.
But with Qualio, I raise something to Lauren, I get an immediate response, consideration of what we need, and so many things we've raised are in the process of being added - or have already been!
Maran was charged with training her colleagues on Qualio, from user permissions to system functionality and 'how tos'.
Maran found it 'easy' to introduce team members to the system and train them in a matter of hours, and the entire business of 88 employees now logs into and uses Qualio to support the organizational quality system.
Watchmaker Genomics now uses Qualio to structure, manage and automate all its core quality management activities, from document control and batch records to training and quality event management.
Peter was impressed by the integrated digital approach to quality compared to what he'd seen at previous businesses.
There were paper batch records lying about, poorly organized supplier files everywhere. It was impossible to maintain and search through.
There were separate systems for documents, training, CAPAs - none of which talked to one another.
As a 3-year old company, we're already working in a better way than some 20- or 30-year-old businesses I've been at in the past.
Qualio empowers Watchmaker Genomics with a single source of truth for:
Documents, including SOPs, master lists, work and manufacturing instructions, Design History Files and more
Quality events, including CAPAs and NCRs
An ordered and structured approach to quality has allowed the business to rapidly expand, from 10 employees when Qualio was implemented to almost 90, and has accelerated the company's pathway to market.
Maran's favorite Qualio functionality is the document prefix, which structures and standardizes company information and makes searching for information rapid and simple.
Peter's most pleased with Qualio's ability to bring all quality information into a single area, rather than relying on clunky cross-system integrations - an evolution he finds both 'refreshing' and 'relaxing'.
And while Watchmaker's ISO 13485 accreditation journey isn't yet complete, Qualio has already helped demonstrate Watchmaker's quality credentials to prospective customers and win new business too:
Customers come to us and ask if we have the core processes covered in ISO 13485.
We can confidently reply yes: we have a document control system, we have version control, we have ways to track training, and they're all covered by a fully validated system.
That gives our clinical customers confidence that we're a company thinking about our quality and compliance obligations.
With 5 product launches on the horizon, Peter, Maran and the team are now focused on building out and expanding system usage to finalize preparations and get to '100% confidence' for their upcoming ISO 13485 Stage 2 audit.
With their 'partnership' with Qualio, rather than a simple 'business relationship', the Watchmaker team can continue to work to their market objectives - underpinned by 'baked-in', not 'tacked-on' quality and a supportive eQMS vendor at their side.