Pharmaceutical LIMS
Managing QC testing in the highly regulated pharmaceutical manufacturing sector and tracking raw ingredients to finished product has never been simpler.
Defined by Standards
Designed specifically for pharmaceutical manufacturing, the Instem Pharmaceutical LIMS is ideal for heavily regulated industries operating to standards such as FDA 21 CFR Part 11, ISO 17025 and cGxP. The Pharmaceutical LIMS drives quality throughout the manufacturing flow by managing and tracking samples of raw materials, intermediate and final products, ensuring they can be rapidly linked to the relevant product and batch. The Instem Pharmaceutical LIMS helps you automate and control your sample testing and record data results, confirming that your product meets your quality standards.
Developed in accordance with our ISO 9001 accredited quality system, the solution is supported by comprehensive validation documentation that provides a head start for validation activities. Unique graphical configuration tools allow the Manufacturing LIMS to be adapted to your specific requirements while the validated core software remains untouched.
Track Raw Ingredients to Final Product with Ease
Whether testing finished goods with the creation of a final Certificate of Analysis (CofA), testing incoming raw materials, or testing intermediate product, the Instem Pharmaceutical LIMS helps you automate and control your sample testing and record data results to satisfy regulatory requirements. The solution drives quality throughout the pharmaceutical manufacturing flow by managing and tracking samples taken and ensuring they can be quickly related to the relevant product and batch.
Key Pharmaceutical LIMS Features & Benefits
Batch and recipe management linking final products to raw materials and suppliers
Manage tests performed at each stage of every batch
Defined specifications and workflows
Integrated instrument interfacing, calibration, maintenance and analyst certification
Built-in security with user-specific access and full audit trail
Management by exception reduces turnaround time
Track manufacturing quality
Eliminate transcription errors through instrument and personnel capability assurance
Aids compliance with FDA 21 CFR Part 11, ISO 17025 & cGxP
Automated data approval for in-specification results
Test to manufacturing specifications
Customer-specific product grading
Integration with ERP and other corporate systems
Complete batch tracking, traceability and genealogy
Validate each production stage
Ensure data integrity
Maximise the value of manufactured material
Increase organisational efficiency
Manage Competency, Quality Cycles & More
In addition to linking samples from raw materials, intermediate product and finished product to their relevant batches, the Instem Pharmaceutical LIMS also manages staff competency, instrument calibration and maintenance, product grading and investigations into quality lapses using CAPA. An environmental monitoring module may also be deployed to manage hygiene testing of the production environment. A stability module enables long-term product stability studies to be conducted and monitored.
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Choose a future-proof, highly adaptable system that enhances accuracy and efficiency across your data management workflows. Matrix Gemini LIMS delivers lasting flexibility and compliance, making it a smart investment that transforms ongoing projects while supporting growth and evolving laboratory needs.
