Topic
LIMS
40 articles tagged "LIMS".
- Chris Chiodo, Founder
How a Small Independent Lab Can Replace Spreadsheets with a Compliant LIMS in 30 Days
A week-by-week plan for consolidating the spreadsheet patchwork into one system of record — without losing data, compliance, or your team's trust. Written by a chemist who has run a lab on FINAL_v7.xlsx.
- Aliquora Team
FDA 21 CFR Part 11 Compliance: A Lab's Real-World Fix
Learn how one small lab closed FDA 21 CFR Part 11 compliance gaps in 90 days—covering audit trails, electronic signatures, and access controls.
- Aliquora Team
ISO 17025 Accreditation for Small Labs: A Step-by-Step Guide
Get your small lab ISO/IEC 17025 accredited with this practical step-by-step guide covering gap assessments, documentation, audits, and common pitfalls to avoid.
- Aliquora Team
Sample Traceability: Why Chain of Custody Is a QC Issue
Sample traceability isn't just a regulatory checkbox — it's the backbone of defensible QC. Learn how chain of custody failures happen and how to close the gaps.
- Aliquora Team
Quality Control Workflow Design: KPIs That Actually Work
Learn how to design a quality control workflow from scratch, assign the right KPIs, and catch failures before they become escapes—step by step.
- Aliquora Team
OOS Investigation Procedures: A Practical SOP Guide
Master out-of-spec investigation procedures with a clear Phase I/II framework, root cause analysis, and CAPA steps designed for small and mid-size QC labs.
- Aliquora Team
FDA 21 CFR Part 11 Compliance: What Labs Actually Need
FDA 21 CFR Part 11 compliance is often misread as a checklist exercise. This guide cuts through the noise and tells you what actually matters for your lab.
- Aliquora Team
Audit Trails & Data Integrity: An ALCOA+ Case Study
See how Meridian BioAnalytics fixed chronic ALCOA+ audit trail failures—reducing findings from 14 to zero and passing two consecutive regulatory inspections.
- Aliquora Team
GLP vs GMP vs ISO 17025: What Small Labs Actually Need
Confused by GLP, GMP, and ISO 17025? This guide breaks down which compliance framework small and mid-size labs actually need — and what auditors look for.
- Aliquora Team
Lab Inventory & Reagent Tracking: A QC Lab Case Study
Poor reagent tracking cost Meridian BioAnalytics weeks of rework. Here's how tightening lab inventory control fixed their QC failures and audit gaps.
- Aliquora Team
Pharma QC Release Testing: A Technical Walkthrough
Pharma QC release testing demands precise method execution, airtight documentation, and defensible OOS handling. This technical guide covers every critical control point.
- Aliquora Team
OOS Investigation Procedures: A Practical SOP for QC Labs
Learn how to structure out-of-spec investigation procedures that satisfy regulators, protect product integrity, and hold up under audit scrutiny.
- Aliquora Team
Training Records & Competency Tracking: A QC Lab Guide
Effective training records and competency tracking are audit table-stakes. Learn how to build a defensible system before your next ISO or FDA inspection.
- Aliquora Team
OOS Investigations: A 7-Step SOP for QC Labs
Master out-of-spec investigations with a clear 7-step SOP that helps QC labs find root causes fast, close CAPAs properly, and stay audit-ready.
- Aliquora Team
Reference Standards Management: A QC Lab Director's Guide
Strong reference standards management prevents OOS failures and audit findings. Learn the controls, workflows, and LIMS features that protect your QC program.
- Aliquora Team
Quality Control Workflow Design: KPIs That Actually Matter
Learn how to design a quality control workflow and choose KPIs that reduce rework and audit risk, using a real-world before/after case from a mid-size QC lab.
- Aliquora Team
Sample Traceability: Why Chain of Custody Is Your Lab's First Line of Defense
Strong sample traceability and chain of custody aren't just audit checkboxes — they're the foundation of defensible lab results. Here's how to get them right.
- Aliquora Team
GLP vs GMP vs ISO 17025: What Small Labs Actually Need
Confused about GLP vs GMP vs ISO 17025? See how one small lab chose the right framework, fixed audit gaps, and cut deviation turnaround time.
- Aliquora Team
Instrument Data Integration: CSV Imports Into Your LIMS
Learn how to map, validate, and automate instrument data integration and CSV imports into your LIMS with a step-by-step guide built for QC labs.
- Aliquora Team
GLP vs GMP vs ISO 17025: What Small Labs Actually Need
GLP, GMP, and ISO 17025 overlap in confusing ways. This technical breakdown helps small lab QA managers choose the right framework—and avoid costly compliance gaps.
- Aliquora Team
GLP vs GMP vs ISO 17025: What Small Labs Actually Need
Confused by GLP, GMP, and ISO 17025? This guide breaks down each framework so small lab QA managers can pick the right compliance path fast.
- Aliquora Team
Lab Reagent Tracking: Stop Treating It as an Afterthought
Poor lab inventory and reagent tracking silently corrupts your QC data. Here's how to build a system that prevents failures before they reach the COA.
- Aliquora Team
COA Design: How to Build a Certificate of Analysis That Passes Audits
Learn how to design a Certificate of Analysis that satisfies regulators, clients, and auditors — with step-by-step guidance and common formatting pitfalls to avoid.
- Aliquora Team
Training Records and Competency Tracking for QC Labs
Competency tracking is the most under-engineered part of lab QC. Learn how to build training records that satisfy auditors and actually prevent errors.
- Aliquora Team
OOS Investigation Procedures: A Phase-by-Phase SOP Guide
Master out-of-spec investigation procedures with a technically rigorous, phase-structured SOP covering root cause analysis, CAPA, and regulatory requirements.
- Aliquora Team
Certificate of Analysis Design: Common Pitfalls to Avoid
A poorly designed Certificate of Analysis undermines trust and invites regulatory scrutiny. Learn which COA elements matter most and where labs consistently go wrong.
- Aliquora Team
LIMS Best Practices for Small and Mid-Size Labs
Practical LIMS best practices for small and mid-size labs — covering sample tracking, OOS workflows, audit trails, and COA generation to strengthen QC operations.
- Aliquora Team
Sample Traceability: How One Lab Fixed Chain-of-Custody Gaps
Discover how Meridian BioAnalytics closed critical sample traceability and chain-of-custody gaps—reducing audit findings and OOS investigation time with a structured LIMS approach.
- Aliquora Team
Food and Beverage QC Essentials for Lab Directors
Master food and beverage QC essentials—from OOS flagging to COA generation—so your lab stays audit-ready and keeps products off recall lists.
- Aliquora Team
LIMS Best Practices for Small and Mid-Size Labs
Learn LIMS best practices that help small and mid-size labs enforce ISO 17025 compliance, close OOS gaps, and build defensible audit trails from day one.
- Aliquora Team
Audit Trails and Data Integrity: ALCOA+ in Practice
Learn how audit trails and ALCOA+ data integrity principles work in real QC labs — and what reviewers actually look for during an inspection.
- Aliquora Team
Audit Trails and Data Integrity: ALCOA+ Checklist for Labs
Master audit trails and data integrity with this ALCOA+ checklist — practical steps QC labs can act on today to satisfy FDA, ISO, and internal auditors.
- Aliquora Team
Lab Reagent Tracking: A 10-Point Checklist for QC Labs
Master lab inventory and reagent tracking with a practical 10-point checklist built for QC labs managing traceability, expiry, and audit readiness.
- Aliquora Team
Quality Control Workflow Design: 10 KPIs Worth Tracking
Improve your quality control workflow with 10 measurable KPIs that help QC managers catch failures faster, reduce rework, and maintain audit-ready records.
- Aliquora Team
Risk-Based QC Sampling: Stop Testing Everything Equally
Risk-based QC sampling directs your lab's testing resources where failure matters most — here's how to build a defensible, tiered sampling strategy.
- Aliquora Team
Instrument Data Integration: Importing CSV Files Into Your LIMS
Learn how to connect lab instruments and import CSV data into your LIMS without errors, mapping mistakes, or audit trail gaps — practical steps for QC labs.
- Aliquora Team
Reference Standards Management: A Step-by-Step SOP for QC Labs
Master reference material and standards management in your QC lab with this step-by-step SOP covering receipt, storage, traceability, and expiry controls.
- Aliquora Team
ISO 17025 Accreditation for Small Labs: What It Actually Takes
ISO/IEC 17025 accreditation for small labs is achievable without a massive QA team — if you understand what auditors actually look for and where to focus.
- Aliquora Team
COA Design: Common Pitfalls and How to Fix Them
Poor certificate of analysis design costs labs audits and customer trust. See how Meridian BioAnalytics overhauled their COA process and what changed.
- The Aliquora Team
What Is a LIMS, and Does Your Lab Actually Need One?
A plain-language guide to Laboratory Information Management Systems — what they do, when spreadsheets stop working, and how to know it's time to switch.