Qualio > Case Studies > Watchmaker Genomics: Implementing Quality Control with Qualio

Watchmaker Genomics: Implementing Quality Control with Qualio

Technology Category

Functional Applications - Manufacturing Execution Systems (MES)

Applicable Industries

Buildings
Education

Applicable Functions

Quality Assurance

Use Cases

Predictive Quality Analytics
Visual Quality Detection

Services

Testing & Certification
Training

About The Customer

Watchmaker Genomics is a company based in Boulder, CO, with 50-99 employees. The company specializes in the protein engineering and enzyme manufacturing sector. Founded in 2019, Watchmaker 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. The company's products are used in CAP/CLIA laboratories for sample analysis, making airtight product quality vital.

The Challenge

Watchmaker Genomics, a company specializing in protein engineering and enzyme manufacturing, faced a significant challenge in establishing a robust quality control system. The company's products are used in CAP/CLIA laboratories for sample analysis, making airtight product quality crucial. CEO Trey Foskett, having established several other companies in the past, was aware of the business impact of implementing a digital quality approach early on, rather than adding it to pre-existing processes. The company was eager to establish a single, central mechanism for managing quality, from accessing daily 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 finding the best possible electronic quality management system (eQMS), and the search began within the first few months of the company's establishment.

The Solution

Skyler and his team chose Qualio as their eQMS vendor, a decision that was later reviewed by Director of Quality Assurance Peter Bruesehoff. Peter found not only a well-established eQMS that the business comfortably engaged with, but also a strong partner relationship with Qualio and a balanced approach between meeting complex quality needs and avoiding overly burdensome customization and validation. Maran, another team member, 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. The entire business of 88 employees now logs into and uses Qualio to support the organizational quality system.

Operational Impact

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. The integrated digital approach to quality has impressed the team, providing a single source of truth for documents, training, quality events, and suppliers. This structured approach to quality has allowed the business to rapidly expand and has accelerated the company's pathway to market. The team appreciates Qualio's ability to bring all quality information into a single area, rather than relying on clunky cross-system integrations. 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.

Quantitative Benefit

The entire business of 88 employees now uses Qualio to support the organizational quality system.
The company has rapidly expanded from 10 employees when Qualio was implemented to almost 90.
Qualio has helped win new business by demonstrating Watchmaker's quality credentials to prospective customers.