Results That Speak for Themselves

Challenge

A 500-person pharmaceutical manufacturer was running a 15-year-old LIMS with no vendor support, manual instrument interfaces, and a growing backlog of 21 CFR Part 11 audit findings.

Approach

Cogsult conducted a full system assessment, selected a modern cloud-based LIMS, and led a phased migration over 14 months. All historical data was migrated with full audit trail preservation. Instrument interfaces were rebuilt using modern bidirectional protocols.

Outcomes

• Zero data loss across 8 years of historical records
• Instrument interface time reduced from 4 hours to 15 minutes per run
• All 21 CFR Part 11 audit findings resolved at first inspection
• User adoption reached 95% within 60 days of go-live

Challenge

A clinical-stage biotech had three disconnected systems — SAP for inventory, a LIMS for sample tracking, and an ELN for experimental data. Scientists were manually transcribing data between all three, creating transcription errors and compliance risk.

Approach

We designed a middleware integration layer connecting all three platforms via API. Sample creation in SAP automatically triggered LIMS workflows. ELN results were pushed directly to LIMS upon approval, eliminating all manual data entry.

Outcomes

• Manual transcription eliminated across 3 platforms
• Data entry errors reduced by 94%
• Sample-to-result cycle time cut from 3 days to 6 hours
• Full audit trail maintained across all three systems

Challenge

A contract research organization processing 2,000+ samples per day was hitting throughput bottlenecks at sample login, result review, and report generation — all manual steps that required dedicated headcount.

Approach

Using Lean Six Sigma methodology, we mapped the full sample lifecycle and identified 11 manual handoff points. We automated sample login via barcode scanning, built rule-based auto-review for routine results, and implemented templated report generation triggered on final approval.

Outcomes

• 11 manual handoff points reduced to 3
• Sample login time reduced by 78%
• Report generation time cut from 45 minutes to under 5 minutes
• Throughput increased by 35% with no additional headcount

Challenge

A regional clinical diagnostics network had expanded rapidly through acquisition and was operating six labs on three different LIMS platforms — none of which had current validation documentation. An upcoming CAP inspection created urgency.

Approach

Cogsult developed a risk-based validation strategy aligned with GAMP 5. We authored IQ/OQ/PQ protocols for all three platforms, executed testing with lab staff, and produced a complete validation package for each site. A harmonized SOP library was developed to support ongoing compliance.

Outcomes

• All six sites validated within 5 months
• CAP inspection passed with zero major findings
• Harmonized SOP library covering 40+ procedures
• Ongoing validation maintenance program established