How to Accelerate Commercialization and Simplify Regulatory Compliance with Stability Study Management, Reporting, and Trending

Feb 19, 2026 | Justin Lavimodiere

Stability studies are a cornerstone of quality in the pharmaceutical and biotech industries. Spanning the entire product lifecycle, this critical testing determines a drug product’s shelf life and recommended appropriate storage conditions. During the pre-commercialization phase, stability studies support regulatory submissions, like an Investigational New Drug (IND) or New Drug Application (NDA); while during the post-commercialization phase, ongoing testing is required to monitor commercial batches and support changes to the manufacturing process or packaging.

In the U.S., the requirement for a formal stability testing program is mandated by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 211.166. This regulation is part of Current Good Manufacturing Practice (cGMP) and requires companies to assess a drug product’s characteristics over time to ensure it maintains its identity, strength, quality, and purity until the assigned expiration date.

Internationally, similar requirements exist to maintain drug product quality. Adherence to guidelines, such as the ICH Q1A(R2) series, is critical for global market acceptance.

Legacy solutions don’t address inherent challenges

Despite the clear regulatory framework, biopharma companies routinely face challenges executing efficient and compliant stability programs. As they often use legacy lab information management systems (LIMS) to address these challenges, their technology requires significant configuration, customization, and validation for study management, reporting, and data trending, resulting in inefficiencies and high costs.

• Study management and timepoint pull compliance: Traditional systems struggle to track stability samples accurately and ensure timely “pulls” for testing. Manual, paper-based, or fragmented systems introduce a high risk of human error and lack real-time visibility, potentially resulting in missing or delayed sample pulls that could invalidate a study and lead to adverse regulatory findings.
• Reporting: Generating compliant stability timepoint summary reports can be a significant administrative burden. Manually compiling data from disparate systems increases the risk of transcription error and makes it difficult to maintain a complete, verifiable audit trail, creating data integrity challenges. Traditional systems that rely on complex legacy reporting tools like Crystal or Jasper reports require niche skills for customization, code writing, and burdensome validation.
• Trending and OOS investigations: Timely trending is essential for proactively identifying degradation issues. However, poor data accessibility and the lack of built-in statistical tools in traditional systems hinder continuous and robust trending. Disconnected lab investigations and quality event management compound inefficiency when these issues arise.

Five features that simplify stability study management

Veeva LIMS offers industry-standard capabilities for cGMP Stability Study Management to accelerate commercialization and simplify regulatory compliance. Leveraging true-SaaS, Veeva LIMS can be implemented rapidly to digitalize operations, replacing slow and error-prone paper-based management of stability studies, stability testing data, trending, and reporting.

With compliant, configurable industry-standard workflows, customers avoid the excessive customization that leads to unnecessary complexity, an increased validation burden, and higher implementation and ownership costs.

Stability study management enables customers to design, execute, and oversee stability studies with inventory and timepoint pull management, test assignment and execution, specification evaluation, multi-level review, and generation of timepoint and study summary reports. Notable features include:

• Visual stability study design builder: Simplify and speed stability study design with a guided, stepwise process supporting end-users with point-and-click configuration of stability studies, including timepoints, testing, specification criteria, and inventory.
• Digital method execution: Perform digital method execution following the effective test method procedure rendered on screen. Ensure compliant usage of instruments, equipment, and consumable inventory, as well as retrieving data from instruments and performing calculations.
• Embedded trending and regression: Proactively prevent product/process failures and recalls before they become specification failures with auto-generated charts. Evaluate regression lines, compare results across timepoint and study, and assess product shelf life.
• Initiate lab investigation: Seamlessly initiate lab investigations in Veeva QMS directly from Veeva LIMS to pass contextual metadata and details and provide immediate visibility for testing issues, out of specification (OOS) and out of trend (OOT) results.
• One-click stability summary report: Speed the generation of industry standard reports with the one-click stability timepoint and summary reports. Display batch and study metadata and test results across timepoint by condition and orientation direct to PDF to maintain accuracy and data integrity. Utilize the report for CMC and APQR.

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