LIMS for Pharmaceutical Labs
Reuben LIMS adapts to your pharmaceutical workflows, rather than forcing you into rigid software. As a modern LIMS solution, it supports quality control, data integrity, and compliance with industry-standard regulatory frameworks.
From QC testing through to batch release, our system is built to be configured around your processes and your compliance framework, helping you meet GMP, Annex 11, MHRA expectations and FDA 21 CFR Part requirements with less effort. As part of broader laboratory information management systems LIMS, it provides the foundation needed for scalable pharmaceutical manufacturing.
Challenges we solve
- Rigid off-the-shelf systems that don’t match your lab’s actual workflow or management system structure.
- Paper and spreadsheets slowing down QA/QC and increasing risk of human error.
- Validation headaches from software changes that don’t align with your QMS or regulatory standards.
- Batch release delays caused by manual approval chains and document errors due to limited workflow automation.
How it works
- Sample intake — set up intake exactly as your lab defines it, from raw material through to finished product, with structured sample tracking and management sample controls.
- Guided testing — configure methods and logic to match your SOPs, not a generic template, using workflow automation designed for regulated environments.
- Review & approval — tailor multi-stage approvals to your team structure, with electronic signature, full audit trail, and versioning to maintain data integrity.
- Certificate of Analysis — generate CoAs automatically in your format, ready for batch release.
- Reporting & dashboards — choose standard metrics or configure KPIs that reflect your priorities, including review turnaround times and quality control indicators.
Key capabilities for pharmaceutical labs
Configurable GxP workflows
- The system is set up to mirror your QMS and validation requirements, so you don’t need to bend your processes to fit rigid software, all while aligning with regulatory standards and industry standard expectations.
Batch & stability testing
- Manage product lifecycles from raw material through to release, with stability studies structured the way your lab already works.
Environmental monitoring
- Capture EM data alongside QC testing, configured around the way your sites and assets are organised, supported by long-term, compliant data handling for pharmaceutical manufacturing.
Custom approvals
- Design sign-off flows that reflect your actual team structure and QA/QC responsibilities, including controls for electronic signature and regulatory traceability.
ERP/MES integration
- Connect seamlessly into your existing quality and manufacturing systems, ensuring data flows where you need it through seamless integration with ERP, MES and integrated ELN platforms.
Outcomes for your lab
Improved accuracy
Reduced compliance risk thanks to workflows that match your QMS and maintain data integrity.
Faster batch release
Tailored CoA generation speeds up approvals and delivery, reducing turnaround times.
Simpler validation
Documentation and processes built to your specific requirements, aligned with FDA 21 CFR Part, Annex 11 and MHRA guidance.
Greater efficiency
Elimination of spreadsheet bottlenecks, duplicate data entry and other sources of human error.
Stronger ROI
Measurable headcount savings and scalable throughput as your lab grows, providing stable long term value.
FAQs
Want a LIMS that fits your workflows, not the other way round?
Book a discovery call and see how Reuben LIMS can be configured for your pharmaceutical lab.
