AS2Bio Builds a Flexible Quality Foundation with ZenQMS QAtalyst

About AS²Bio

AS²Bio is a startup biotechnology company that advances promising therapies in the Angelman syndrome space from early stage candidate to clinical trial. Before transitioning from a preclinical to clinical stage company with its first clinical trial, the AS²Bio quality team needed controlled processes that could support immediate priorities and evolve as the company and its portfolio companies matured.

Success Highlights

• Launched document control quickly: Migrated critical documents and began releasing controlled documents through ZenQMS from day one.
• Centralized audit activity: Uses ZenQMS to capture observations and support vendor and study-process audits.
• Started with a flexible foundation: Used QAtalyst’s preconfigured workflows and templates as a starting point, then tailored them to fit AS²Bio’s needs.

Finding a Starting Point Without Sacrificing Flexibility

AS²Bio needed to move quickly. But with many of its quality processes still taking shape, the team didn’t want a rigid system – or a blank slate.

Some eQMS platforms came with highly prescribed workflows that would require AS²Bio to change how it is currently operated or planned to operate. A more configurable platform offered flexibility, but designing every process from scratch would place a heavy burden on its lean quality team.

“Some other platforms come already very configured, and you need to figure out a way to make your organization match that. ZenQMS gave us the ability to design things the way we wanted – but at that stage, we hadn’t designed every process yet.”
– Scott Pherson, Senior Director, Quality Assurance, AS²Bio

AS²Bio needed enough structure to get started, with the flexibility to quickly adapt each process as the company’s needs became clearer.

A Preconfigured QMS Foundation that AS²Bio Could Make Its Own

Melissa Scaccia, Senior Manager of Quality Assurance at AS2Bio, had used ZenQMS in a previous role. When AS²Bio began building its quality system, she knew the platform could provide the flexibility the company needed.

ZenQMS QAtalyst added the starting framework. Its preconfigured workflows, templates and supporting structures gave the team something tangible to review instead of asking stakeholders to design each process from a blank page.

“We had something ready to circulate with the team. People could see how the process worked, understand it and identify what they wanted to adjust.”
– Scott Pherson, Senior Director, Quality Assurance, AS²Bio

QAtalyst shifted internal conversations from “Where do we start?” to “What should we adjust?” It also gave the team confidence that it was building from an informed recommendation rather than an arbitrary set of decisions.

“I could fill out the templates, give them to the implementation team and not have to start from scratch. Here’s what you have to tweak, here’s the container where you put your information, and then – voilà – it’s there.”
– Melissa Scaccia, Senior Manager, Quality Assurance, AS²Bio

Because AS2Bio was still defining several quality processes, the team could build them with ZenQMS in mind from the outset rather than translate established manual processes into a new system later.

“It gave our team and our executive leadership peace of mind,” Melissa said. “We weren’t simply coming up with ways to configure the system that we thought were right.”

Controlled Documents From Day One

Document management was one of AS²Bio’s first priorities. The company migrated several dozen documents into ZenQMS while preserving important metadata.

Before ZenQMS, AS²Bio used DocuSign to collect document signatures. Although the signatures were electronic, the rest of the document control process still had to be managed separately with potential for data integrity pitfalls.

With ZenQMS, AS²Bio manages document review, approval and release through controlled and compliant workflows. SOPs and other quality documents no longer need to be circulated through email or SharePoint.

“We were able to put workflows in place and release documents using ZenQMS from day one instead of relying on our clunkier DocuSign process. That was an instant win.”
– Scott Pherson, Senior Director, Quality Assurance, AS²Bio

Centralizing Audit and Vendor Management

AS²Bio works extensively with external vendors. The quality team needed a practical way to schedule audits, capture observations and maintain a consistent history of vendor oversight.

AS²Bio now uses ZenQMS audit management software to support vendor qualification audits, study-process audits and vendor assessment questionnaires. 

Audit information and observations are captured in ZenQMS using standardized categories. AS²Bio is also working to add historical audit records, giving the team a more centralized view of activity over time across all vendors.

“We want all of that history centrally located in ZenQMS. Instead of someone having to find an old email or another document, we’ll be able to look at the previous audit, review the observations and determine whether anything has repeated.”
– Scott Pherson, Senior Director, Quality Assurance, AS²Bio

As more information is added, AS²Bio plans to use it to support audit scheduling, trending and future quality management reviews.

Building the Next Phase at AS²Bio’s Pace

With document control established and its audit processes coming online, AS²Bio is building and testing deviation and CAPA workflows.

The team began with the processes available through QAtalyst, then used ZenQMS’s configurable Issues and CAPA management tools to adjust workflow steps around its requirements and stakeholder feedback.

A sandbox environment allows AS²Bio to test configurations before moving them into production. Melissa can also use a separate test account to see what workflows look like for employees without super-user access.

“We appreciate the system’s flexibility and the ability to change steps along the way.”
– Scott Pherson, Senior Director, Quality Assurance, AS²Bio

AS²Bio can perform much of this work independently while turning to the ZenQMS team when questions arise.

“Cason and the Zen Support Team are always available and very prompt when I have questions,” Melissa said. “Beyond the initial setup, we haven’t needed too much support.”

A QMS Foundation Designed to Grow

AS²Bio didn’t need to launch every quality process at once. It needed the right foundation and the ability to expand when the organization was ready.

QAtalyst helped the team move forward without forcing AS2Bio into a fixed way of working. ZenQMS supported its first immediate need – controlled document management – and now provides a central foundation for audits, vendor oversight and future quality processes.

For emerging life sciences teams facing the same choice between a rigid system and a blank slate, AS2Bio’s experience shows another option: start with a proven quality foundation, adapt it to the business and build from there.

See How QAtalyst Can Help Your Team Get Started

QAtalyst gives early-stage life sciences teams preconfigured workflows, SOP templates, roles, training structures, and more – all within the flexible ZenQMS platform.

See how ZenQMS can help your team establish a flexible quality foundation without building from scratch. Request a demo today!

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