Quality at ABC-Plan

We believe everyone deserves safe, timely access to medication. That’s why quality isn’t just a practice at ABC-Plan—it’s our promise. Pharmaceutical and BioTech companies rely on us to ensure their supply chains run without surprises—because patients can’t afford delays or stock-outs. Every feature we ship and every system we deploy is driven by that higher purpose.

 

In an age of technology buzzwords, we focus on something more fundamental: Does it work? Will it hold up under pressure? Is it audit-ready? Our commitment to quality means building systems that are testable, observable, and resilient from day one.

Our Approach

Our Quality Engineering Framework aligns our day-to-day work with long-term operational excellence. It’s built on proven practices, applied rigorously:

1. Align Before You Build

We use Behavior-Driven Development (BDD) to clarify expectations with customers and to ensure team alignment from sales to engineering to operations. This shared understanding eliminates ambiguity and guides design and development with user impact in mind.

2. Build Correctness In

We use Test-Driven Development (TDD) to define outcomes before we write production code. This practice ensures software is built to meet its requirements from the start—not retrofitted later.

3. Automate Early

By automating early and broadly, we reduce regression, support faster iteration, and empower developers to refactor safely. Automation isn’t a phase—it’s a mindset.

4. Test What Matters

We follow Guillermo Rauch’s principle: “Write tests. Not too many. Mostly integration.” We emphasize meaningful coverage—favoring full-stack integration tests where possible, backed by unit tests when valuable.

5. Anticipate Failure

We engineer for the unexpected. Our test suites include failure modes, edge cases, and invalid inputs to simulate the real-world chaos of production environments. That means fewer surprises—and faster recovery.

6. Explore Beyond the Scripts

Automated tests don’t catch everything. We conduct exploratory testing around high-risk flows and new features, using human insight and domain expertise to detect usability issues, edge cases, and numerical accuracy.

7. Observe and Improve

We use Sentry.io for real-time error monitoring and maintain internal dashboards to track system health, latency, and user-impacting anomalies. We combine automation and human oversight to respond fast and learn continuously.

8. Deliver with Confidence

Thanks to this layered approach, we’ve achieved 99.9% uptime and released with confidence across environments. Quality enables agility—and agility enables better service for our customers and theirs.

Validation

For customers operating in regulated environments, we support validation under 21 CFR Part 11. This applies to our Inventory Management (Virtual Manufacturing MRP) product. Here’s how we meet the core requirements:

 

The FDA requires that regulated entities—our customers—submit a Letter of Non-Repudiation Agreement to certify that their electronic signatures are legally binding equivalents of handwritten ones. ABC-Plan supports this process by providing the technical capabilities, validation documentation, and audit evidence needed for compliance.

Access & Authentication

• Each user has a unique ID and secure password
• Access restricted to authorized personnel only, with role-based access control
• In combination with Single Sign-On (SSO) via SAML, customer IT departments can configure their policies to comply with the FDA:
  • Two-factor authentication
  • Credential expiration and session management
  • Automatic logoffs and session timeouts
• See our Security Policy for full details

Electronic Signatures

• Includes signer name, date/time, and intent (e.g., approval per transaction)
• Displayed in human-readable format
• Permanently linked to record

Audit Trails

• Tracks who, what, when, and optionally why
• Logs are tamper-evident and unmodifiable
• Audit logs stored securely with access controls

Validation & Documentation

• System validation procedures aligned with GxP expectations
• Change control and traceability maintained
• Validation packages available upon request

Data Integrity

• Controls are in place to prevent unauthorized data alteration or loss
• All electronic records are backed by automated monitoring and recovery systems

Compliance

• ABC-Plan implements controls across audits, system validations, audit trails, electronic signatures, and documentation to comply with FDA predicate rules

Contact Us

Have questions about our quality processes? Reach out to us at [email protected].

 

If you would like to speak directly with our Designated Quality & Privacy Officer, our cofounder and CTO, Michael Osofsky, is available. His contact info is simply his first name at our domain name.