GxP-Compliant LIMS for Pharmaceutical QC, QA, and Stability Testing
LIMSera streamlines pharmaceutical quality control and quality assurance workflows with validated electronic records, 21 CFR Part 11 compliant e-signatures, and end-to-end batch traceability. Manage raw material testing, in-process controls, finished product release, and ICH stability studies from a single platform. Automate out-of-specification (OOS) investigations, generate Certificates of Analysis (CoA), and maintain audit-ready documentation that satisfies FDA, EMA, and CDSCO inspectors.
Key Challenges in Pharmaceuticals Laboratories
These are the operational, regulatory, and data-management pain points that labs in this industry face every day.
Maintaining 21 CFR Part 11 compliance with electronic signatures, audit trails, and data integrity (ALCOA+ principles)
Managing complex ICH stability study protocols across multiple storage conditions and time points
Automating OOS investigation workflows with root cause analysis and CAPA tracking
Handling high-volume QC testing with rapid batch release turnaround to meet production schedules
Integrating with HPLC, GC, dissolution, and other analytical instruments for direct data capture
How LIMSera Solves Them
Purpose-built features that directly address the challenges your laboratory faces.
21 CFR Part 11 compliant electronic signatures with biometric and password-based authentication
ICH stability study planner with automated pull scheduling, storage condition monitoring, and trend analysis
OOS/OOT investigation workflow with configurable escalation paths and CAPA integration
Automated Certificate of Analysis (CoA) generation from approved test results
Instrument integration for HPLC, GC, UV-Vis, dissolution, and Karl Fischer systems
Batch genealogy and raw material traceability across the entire product lifecycle
Validated environment with IQ/OQ/PQ documentation package included
Key Parameters Tested
Comprehensive parameter coverage for pharmaceuticals laboratory testing.
Compliance Standards
LIMSera helps you meet and maintain compliance with these regulatory and accreditation requirements.
“A mid-size pharma manufacturer reduced batch release time from 5 days to 18 hours and eliminated three repeat FDA 483 observations related to data integrity after implementing LIMSera across their QC and stability departments.”
See LIMSera in Action for Pharmaceuticals
Get a personalized walkthrough tailored to pharmaceuticals laboratory workflows, compliance needs, and integration requirements.