Dezen Technology
Pharmaceutical · SaaS

Stability Management

Stability You Can Trust. Data You Can Defend.

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Overview

About the product

End-to-end stability study management to ensure product quality, support shelf-life claims and meet global regulatory requirements — from study design through sample inventory, scheduled testing, evaluation and submission-ready reporting.

Stability Management — study planning, sample inventory, testing, evaluation and reporting
Modules

What’s inside

01

Study Planning & Design

  • Create and manage stability protocols (ICH, internal, customer specific).
  • Define study type, product, batch, pack size, strength and configuration.
  • Set storage conditions, pull intervals and test parameters.
  • Auto-generate sample labels and schedules.
  • Track study status from initiation to completion.
02

Sample & Inventory Management

  • Manage sample receipt, dispensing and storage.
  • Track sample quantities, locations and balance.
  • Maintain chain of custody and sample traceability.
  • Manage returns, destruction and disposition.
  • Integration with inventory and batch management.
03

Testing & Data Capture

  • Plan and execute scheduled testing as per pull intervals.
  • Record results manually or via instrument integration.
  • Ensure data integrity with audit trail and electronic records.
  • Handle OOS/OOT, retest and investigations.
  • Attach supporting documents, chromatograms and raw data.
04

Stability Evaluation

  • Trend analysis and regression for key parameters.
  • Compare results against specifications and acceptance criteria.
  • Generate shelf-life, retest period and expiry recommendations.
  • Interactive graphs and dashboards.
  • Document conclusions and review with electronic approvals.
05

Reporting & Documentation

  • Generate standard and custom stability reports.
  • Summarise study status, results and trends.
  • Export data for submissions and regulatory filings.
  • Maintain electronic signatures and approvals.
  • Archive studies for long-term retention.
How it works

End-to-end workflow

  1. 1

    Create study

    Define protocol, product, batch, conditions and test parameters.

  2. 2

    Receive & prepare samples

    Receive samples, label and store as per the protocol conditions.

  3. 3

    Schedule & perform testing

    Execute testing per the schedule and record results in the system.

  4. 4

    Evaluate & review

    Analyse trends, compare against specifications and review the results.

  5. 5

    Conclude & report

    Generate reports, approve conclusions and archive the study record.

Key benefits

Why teams choose Stability

Ensure product quality

Monitor product performance over time to ensure safety, efficacy and quality.

Regulatory compliance

Meet global stability requirements and support successful inspections.

Optimise shelf-life

Generate accurate shelf-life and retest period to reduce risk and wastage.

Reduce cost & effort

Automate stability operations and reduce manual tracking and errors.

Data integrity

ALCOA+ compliant records with complete audit trail and security.

Built for compliance

Designed against the same standards your auditors check.

  • 21 CFR Part 11
  • ALCOA+
  • GMP
  • Audit-ready
Our Work

OUR PORTFOLIO

Sample

Sample

Calibration

Calibration

Inventory

Inventory

Ready to roll out Stability?

Talk to our team about a tailored deployment.

Let’s Discuss
Contact Details : sales@dezentech.com Sy. No:40, Flat No:402, SIRISAMPADHA ARCADE I, Plot no:18-21, behind Union Bank of India, Khajaguda, Hyderabad, Telangana 500104
FAQ

Frequently Asked Questions

Common questions about Dezen lab software products.

We design, build and operate software products across the full lifecycle — strategy, UX, engineering, cloud and ongoing support — so your team can focus on outcomes.