LDMS

Empowering Labs with Compliant Data Management

LDMS is a comprehensive, end-to-end data management platform crafted specifically for bioanalytical and BA/BE analytical laboratories. It streamlines chromatogram review, results aggregation, audit trails, and data workflows — all under a unified, compliant system.

Challenges in Bioanalytical / BA-BE Labs

  • Regulatory & Compliance Pressure
    Adhering to USFDA, EMA, CDSCO, ICH guidelines while maintaining auditable records and documentation.
  • Data Integrity Risks
    Manual transcription, version drift, missing audit trails, and untraceable edits.
  • Complex Analytical Workflows
    Multiple batches, cross-study comparisons, reprocessing, reruns, data merges.
  • Fragmented Systems & Data Silos
    Disparate instruments, isolated data files, and disconnected review platforms.
  • Time-Consuming Review Cycles
    Slow review loops, back-and-forths between analysts, reviewers, QC and QA.
  • Traceability & Audit Readiness
    Ensuring every action is recorded, traceable, and defensible during audits.

Our Solution

  • Regulation-First Design
    Deep built-in controls aligned with 21 CFR Part 11, GxP, GLP, and ALCOA+ principles — audit trails, e-signatures, versioning, role-based access.
  • Review Workflows & Sign-Offs
    Multi-tier review paths: Analyst → Reviewer → QC → QA, with electronic sign-off and full traceability.
  • Unified Data Repository
    Centralize chromatograms, integration results, metadata, and processed tables — all accessible from one secure database.
  • Reporting & Export
    Generate review summaries, audit reports, and export in PDF, Excel or standardized formats for submission.

Why choose LDMS?

  • Operational Efficiency
    Faster review cycles, fewer errors, improved throughput.
  • Elevated Data Integrity
    Trustworthy traceability and control over edits, versions, and sign-offs.
  • Audit & Regulatory Confidence
    Always submission-ready — full documentation, signature tracking, version history.
  • Scalable & Flexible
    Adaptable to small studies or large-scale projects; customizable to lab workflows.
  • Customer-Centric Support
    Dedicated support, training, and upgrades — we grow with your lab.
  • Reliability You Can Rely On
    Built for 24×7 operations, with backup, monitoring, and redundancy in mind.

Get Started

Elevate your laboratory’s data workflows with LDMS. Contact us today for a product demo, and see how LDMS can transform your data review and compliance practices.

Neopharmtech India Private Limited

#109, Bhavya Majestic Enclave,
Madhava Nagar Colony,
Miyapur, Hyderabad, Telangana 500049
+91 79979 97162
info@neopharmtech.com
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