Updates, deep dives, and notes from the lab.
Browse by topic
Learn how one small lab closed FDA 21 CFR Part 11 compliance gaps in 90 days—covering audit trails, electronic signatures, and access controls.
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.
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.
Learn how to design a quality control workflow from scratch, assign the right KPIs, and catch failures before they become escapes—step by step.
Cannabis testing lab compliance doesn't have to be overwhelming. This guide covers sample tracking, OOS handling, COA best practices, and audit-ready documentation.
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.
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.
Master food and beverage QC with this practical step-by-step guide covering sample intake, OOS flagging, COA generation, and audit-ready recordkeeping.
Food and beverage QC isn't just about passing audits — it's about building systems that catch failures before product ships. Here's what actually matters.
See how Meridian BioAnalytics fixed chronic ALCOA+ audit trail failures—reducing findings from 14 to zero and passing two consecutive regulatory inspections.
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.
Poor reagent tracking cost Meridian BioAnalytics weeks of rework. Here's how tightening lab inventory control fixed their QC failures and audit gaps.
Meet cannabis testing lab compliance requirements without gaps: this step-by-step SOP covers sample intake, OOS flagging, COA generation, and audit-ready recordkeeping.
Pharma QC release testing demands precise method execution, airtight documentation, and defensible OOS handling. This technical guide covers every critical control point.
Stability studies live or die on storage condition discipline. Learn how to design protocols, set intervals, and flag failures before they become costly OOS events.
Learn how to structure out-of-spec investigation procedures that satisfy regulators, protect product integrity, and hold up under audit scrutiny.
Effective training records and competency tracking are audit table-stakes. Learn how to build a defensible system before your next ISO or FDA inspection.
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.
Strong reference standards management prevents OOS failures and audit findings. Learn the controls, workflows, and LIMS features that protect your QC program.
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.
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.
Pharma QC release testing determines whether a batch ships or gets rejected. Here's the decision framework lab directors need to cut delays and stay compliant.
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.
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.
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.
Cannabis testing lab compliance trips up even experienced teams. Here's what regulators actually flag—and how to fix it before your next audit.
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.
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.
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.
Competency tracking is the most under-engineered part of lab QC. Learn how to build training records that satisfy auditors and actually prevent errors.
Master out-of-spec investigation procedures with a technically rigorous, phase-structured SOP covering root cause analysis, CAPA, and regulatory requirements.
A poorly designed Certificate of Analysis undermines trust and invites regulatory scrutiny. Learn which COA elements matter most and where labs consistently go wrong.
Practical LIMS best practices for small and mid-size labs — covering sample tracking, OOS workflows, audit trails, and COA generation to strengthen QC operations.
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.
Master food and beverage QC essentials—from OOS flagging to COA generation—so your lab stays audit-ready and keeps products off recall lists.
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.
Cannabis testing lab compliance failures follow predictable patterns. Learn the four areas regulators scrutinize most and how to close those gaps before an audit.
Learn how audit trails and ALCOA+ data integrity principles work in real QC labs — and what reviewers actually look for during an inspection.
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.
Cannabis testing lab compliance failures trigger license suspensions and recalls. Here's what lab directors need to audit, fix, and document right now.
Master lab inventory and reagent tracking with a practical 10-point checklist built for QC labs managing traceability, expiry, and audit readiness.
Improve your quality control workflow with 10 measurable KPIs that help QC managers catch failures faster, reduce rework, and maintain audit-ready records.
Risk-based QC sampling directs your lab's testing resources where failure matters most — here's how to build a defensible, tiered sampling strategy.
Master food and beverage QC with this practical 10-point checklist covering sampling, OOS flagging, COA generation, and audit trail requirements.
Master food and beverage QC with precise guidance on critical control points, regulatory standards, and lab workflows that keep products safe and audit-ready.
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.
Master reference material and standards management in your QC lab with this step-by-step SOP covering receipt, storage, traceability, and expiry controls.
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.
Poor certificate of analysis design costs labs audits and customer trust. See how Meridian BioAnalytics overhauled their COA process and what changed.
Lab automation isn't just for pharma giants. This 2,400-word guide shows 15 workflows to automate, real time savings, and ROI calculations proving LIMS pay for themselves in days.
Pursuing ISO 17025? Your LIMS is your compliance foundation. This 2,600-word guide covers all requirements, ALCOA+ principles, audit checklists, and implementation strategies.
Excel costs labs $67,000/year in hidden waste. This 4,000-word guide shows exactly why 78% of labs are switching to LIMS, with real ROI calculations, case studies, and step-by-step transition plans.
ISO 17025 is dense, but you don't have to read it cover-to-cover on day one. Here's a sane order to tackle it for a lab pursuing accreditation.
ISO 17025 labs need LIMS with audit trails, electronic signatures, and data integrity controls. Complete compliance checklist and affordable solutions.
Environmental labs need mobile-friendly LIMS for field sampling, EPA compliance, and diverse test matrices. Compare options and find affordable solutions for small labs.
Excel works for small labs, but breaks at scale. Learn when to upgrade to LIMS, how to calculate ROI, and migrate without disrupting your lab.
Complete guide to choosing LIMS software for contract testing labs. Compare enterprise vs. cloud LIMS pricing, features, and implementation times.
Complete guide to choosing LIMS software for cannabis testing labs in 2026. Compare pricing, features, and implementation times for small to medium cannabis labs.
A pragmatic OOS workflow for small QC labs — triage, investigation, root cause, and the documentation auditors expect.
What every COA should contain, what it should never contain, and how to design a template your customers (and auditors) will actually trust.
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.