At BioIT Solutions, we’ve seen many of our customers start their digitization journey with stability testing. It’s a logical entry point, and in this article, we’ll explore why it’s the perfect candidate for a digital transformation and how it can lead to substantial time savings and risk reduction.

Under 21 CFR Part 211, Section 166, pharmaceutical companies must establish stability testing programs to determine the shelf life and permissible storage conditions for marketed drug products. Initially, many laboratories bootstrap their stability operations with manual processes. While this approach may work for simple study designs or a handful of lots, it becomes unsustainable as the number and complexity of studies grow.

Stability testing involves several interconnected steps, each requiring meticulous attention:

  • Inventory Management: Bulk materials are aliquoted into individual vials, labeled according to storage conditions, and logged in inventory systems. These records must be updated with precise storage locations to ensure traceability.
  • Stability Calendars: A detailed schedule tracks pull dates for each study, specifying when materials must be retrieved from storage. Missing a pull date can jeopardize regulatory filings and invalidate results.
  • Analytical Backlog: Once materials are retrieved, they often require preparation before testing. Stability samples then enter the analytical testing queue, combining with other workstreams such as in-process, release, raw material and even environmental testing.
  • Data Analysis: After testing, results are added to the accumulating dataset. Evaluating stability data often involves regression analysis, comparing trends against acceptance ranges and identifying deviations from baseline (T0) readings. Following ICH Q1A (R2) guidelines ensures compliance with global standards for establishing shelf life.

Each of these steps is manageable on its own, but together they create a web of complexity that manual methods can struggle to support.  Digitization transforms stability testing by automating repetitive tasks, reducing human error, and centralizing data for real-time decision-making. Imagine managing dozens of studies with overlapping pull dates, each requiring precise timing and data integrity. A digital solution ensures nothing falls through the cracks.

For example, one of our customers, a multi-valent vaccine manufacturer, faced a unique challenge. Each serotype of their vaccine was manufactured in sequence, creating a “rolling enrollment” scenario where intermediate lots entered stability as they were produced. Their manual methods couldn’t keep up, leading to missed pull dates and delays in regulatory filings. By partnering with BioIT Solutions, they digitized their stability program, achieving an 80% reduction in reporting turnaround times and virtually eliminating missed pull dates. The implementation streamlined their operations, allowing them to focus on science instead of paperwork.

The advantages of digitizing stability testing go far beyond time savings. Here’s what you can expect:

  • Improved Accuracy: Automated systems reduce errors in inventory tracking, scheduling, and data analysis.
  • Real-Time Insights: Dashboards provide instant visibility into study progress, allowing teams to identify trends and address issues before they escalate.
  • Regulatory Compliance: Digitized systems simplify adherence to 21 CFR Part 211 and ICH Q1A (R2), ensuring audit readiness and data integrity.
  • Scalability: A digital platform can grow with your operations, accommodating increased study volume and complexity without additional strain.

If your stability program is becoming too complex to manage manually, digitization could be the solution you need. Start by evaluating your current processes and identifying areas where technology can provide immediate value. Consider piloting a digital tool in a single workstream, such as stability calendar management, to test its impact. Once you see the benefits, scaling up becomes a natural next step.  At BioIT Solutions, we specialize in helping biotech companies like yours streamline their operations and achieve their goals.

If you’re ready to take the next step, contact us at sales@bioit.com or visit www.bioit.com. And don’t forget to follow us on LinkedIn for more insights and updates.