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.