KeyPedia™ Media

Blog Post

KeyPedia Labs: The First Full AR Auditor

Sep 10, 2026

George Kwiecinski, Jacob Zheng +1 more

What will auditing look like in the future? KeyPedia Labs explores the AR Auditor — smart glasses that record, process, and cite regulations in real time during facility walkthroughs.

Announcement

KeyPedia Adds State Board of Pharmacy Regulations

Sep 7, 2026

George Kwiecinski

Search California, Arizona, and Indiana Board of Pharmacy regulations on KeyPedia. Full rule text, citations, status, effective dates, and change history.

Blog Post

KeyPedia September 2026 Updates

Sep 7, 2026

George Kwiecinski

KeyPedia 26.9.1: a smoother path from viewing to exporting to integrating, a more powerful search, a refreshed media page, and new state pharmacy records.

Blog Post

Introducing KeyPedia Labs

Sep 1, 2026

George Kwiecinski

KeyPedia Labs is the independent R&D and innovation arm of KeyPedia, producing peer-reviewed research and translating findings into practical tools and methods.

Blog Post

KeyPedia Document and Profile Hub

Sep 1, 2026

George Kwiecinski

How the KeyPedia Document and Profile Hub connects FDA source documents with structured observations, entity relationships, and risk analysis.

Blog Post

The Intelligence Layer: Between Evidence and Execution

Aug 28, 2026

George Kwiecinski

KeyPedia founder George Kwiecinski explains the intelligence layer connecting regulatory evidence, professional judgment, and regulated execution decisions.

Blog Post

What the FDA Is Actually Building With AI: Inside the FY25 HHS Use Case Inventory

Aug 4, 2026

Jacob Zheng & KeyPedia Agent

HHS reported 446 AI use cases in FY25, 67 of them FDA's. We read the inventory so you don't have to — what the agency is building, and why it mirrors KeyPedia's thesis.

Tutorial

Analyze Hundreds of FDA Observations Against Your Own in Minutes

Aug 4, 2026

Jacob Zheng & KeyPedia Agent

Benchmark hundreds of FDA observations against agency reference data in the time it takes to read one warning letter, with KeyPedia Predictive and Flagship.

Blog Post

AI tools at the FDA, how KeyPedia is ELSA for industry

Aug 3, 2026

George Kwiecinski & Jacob Zheng

Critical Tools in AI: What AI Tools Are Actually Saving Time in Today's Modern Landscape As the artificial intelligence landscape evolves rapidly, it can be ...

Blog Post

KeyPedia Labs: The Future of FDA Browsing

Jul 31, 2026

Jacob Zheng & KeyPedia Agent

KeyPedia Labs on the future of FDA browsing — a GKS browser extension that recognizes every FDA link we track and offers a better, searchable, archived version of the page.

Tutorial

Predicting FDA Observations in 3 Simple Steps

Jul 30, 2026

Jacob Zheng & KeyPedia Agent

Use KeyPedia Predictive to see the likely 483 observations for a product, facility, or topic before an investigator ever writes them. Three steps.

Blog Post

Every FDA Warning Letter, Tracked by KeyPedia

Jul 29, 2026

KeyPedia Agent

How GKS maintains a continuously monitored, structured, searchable data source for FDA warning letters — capture, archival, and change detection, from a developer's perspective.

Tutorial

How to Save a Search in KeyPedia

Jul 24, 2026

Jacob Zheng, KeyPedia Agent +1 more

Step-by-step guide to saving, managing, and reusing searches in the GKS KeyPedia dashboard. Bookmark your filters and keywords for quick access.

Tutorial

Premium

How to Download KeyPedia Data

Jul 24, 2026

Jacob Zheng & KeyPedia Agent

Learn how to search, filter, and download regulatory data from the GKS KeyPedia dashboard. Step-by-step guide for pharma and medical device quality teams.

Webinar

July Book Review - Bottle of Lies

Jul 15, 2026

Sydney Caudle

Earlier this year, Keypedia published a paper called The Foreign Inspection Gap, a look at how differently the FDA treats foreign and domestic inspections af...

Blog Post

Intern Day at Keypedia - June 2026

Jul 6, 2026

Sydney Caudle

Why Intern Day Matters at KeyPedia Our interns are based in our Scranton office. This week, we brought them to our primary office in Brooklyn for the day, so...

Tutorial

How to Monitor Every 503B Outsourcing Facility From One Upload

Jul 2, 2026

Sydney Caudle

How to Monitor Every 503B Outsourcing Facility From One Upload The drugs administered at your hospital don't all arrive one prescription at a time. A large s...

Press Release

Press Release: KeyPedia Acquires riskbased.ai

Jul 1, 2026

Sydney Caudle

KeyPedia, formerly Global Key Solutions, acquires a leading FDA MAUDE analytics platform, expanding into devices, combination products, and biologics.

Blog Post

Formal Transition to KeyPedia

Jun 30, 2026

Sydney Caudle

➡️ Global Key Solutions is now KeyPedia. Our product has carried the KeyPedia name for almost a year. We made the company match it.

Blog Post

Your Product Didn't Come With a Manual. Now It Does.

Jun 29, 2026

Jack Summers

Your Product Didn't Come With a Manual. Now It Does. Inspired by Xia Huang, Ph.D., Project Manager at DEKRA, speaking at the 2026 ISPE AI in Life Sciences Su...

Blog Post

Premium

How KeyPedia Assists CSV/CSA Workflows

Jun 25, 2026

Sydney Caudle

How Krieger Scientific uses KeyPedia to score facilities, prep site visits, and give clients real, defensible FDA facts.

Blog Post

2026 ISPE AI in Life Sciences Summit Recap

Jun 24, 2026

George Kwiecinski

A firsthand recap of the 2026 ISPE AI in Life Sciences Summit in Boston: key sessions, speakers, and takeaways on AI, data integrity, and quality.

Webinar

KeyPedia Unlocked Ep. 1: Steve Prewitt on Where AI Actually Works in Pharma

Jun 15, 2026

Sydney Caudle

Where AI actually gets adopted in pharma, why regulatory work is ripe for automation, what makes a real vertical AI company, and why 2026 is a great time to found one.

Announcement

Global Key Solutions Moves to keypedia.com: What You Need to Know

Jun 12, 2026

KeyPedia Agent

Global Key Solutions has moved to keypedia.com. Same product, same team, one new home. All GKS links redirect, and old logins work until July 15, 2026.

Are FDA Drug-483 Standards Rising Relative to PDA Technical Reports?

Blog Post

Premium

Are FDA Drug-483 Standards Rising Relative to PDA Technical Reports?

Jun 9, 2026

Austin Caudle, George Kwiecinski +1 more

KeyPedia analyzed 7,997 drug-related FDA Form 483s (2016–2025): aseptic citations held flat while data integrity and quality risk management climbed sharply.

Blog Post

Industry, Innovation, and Policy in Uncertain Times, 2026 DC ISA Conference

Jun 6, 2026

George Kwiecinski

A recap of the 2026 Industry Studies Association Conference in Washington, DC, covering FDA foreign inspection gaps, drug supply chain security, and procurement.

Tutorial

Using KeyPedia for Annual Product Reviews in Pharma

Jun 5, 2026

Jacob Zheng & KeyPedia Agent

The Annual Product Review is required under 21 CFR 211.180(e). See how KeyPedia pulls the FDA and global signals for your product, facility, and suppliers so the APR writes itself.

Blog Post

Senate Aging Committee Hearing, Poisoned Pills: The Human Cost of Dangerous Foreign Drugs

Jun 5, 2026

George Kwiecinski

Inside the Senate Aging Committee's "Poisoned Pills" hearing, witnesses on generic drug quality, pre-announced foreign inspections, and the case for testing every batch.

Announcement

Call for Participants: Defining Quality Intelligence (QI)

Jun 2, 2026

George Kwiecinski

A confidential, multi-institution practitioner study by NYU Tandon, University of Scranton, and Marywood University defining Quality Intelligence in pharma.

Blog Post

PDA Whiteboard Paper #1: The Prevalence of AI in FDA Correspondence

May 28, 2026

George Kwiecinski

GKS archives PDA Whiteboard Paper #1 by George Kwiecinski, a review of five FDA documents referencing AI, rated 5 stars by the PDA community.

Webinar

FDA RRAs: Navigating FDA’s Alternative Oversight Tools, May WLW

May 27, 2026

Daniel Barreto & Zephaniah Odidika

FDA Remote Regulatory Assessments (RRAs) and Remote Interactive Evaluations (RIEs) are changing how the FDA oversees regulated companies. Learn how remote reviews can lead to Warning Letters, inspections, and major compliance consequences.

Tutorial

Using Data for Strategic Clarity: Questions to Ask

May 19, 2026

George Kwiecinski

The right regulatory data is only useful if you ask the right questions. A short guide for quality leaders, biotech execs, and boards on what to ask, and where.

Tutorial

What is a KRA Score

May 19, 2026

George Kwiecinski

The KRA Score is a single risk rating for any FDA search, facility, company, product class, or jurisdiction. Defensible, regulator-grounded, in minutes.

Tutorial

Reverse Monitoring: Not Just Supplier Monitoring, Save OEMs and Rank Facilities

May 7, 2026

KeyPedia Agent

Reverse monitoring goes beyond supplier oversight. Save OEMs, rank facilities, and surface regulatory signals on customers and competitors in KeyPedia.

Announcement

Introducing KeyPedia Lite Library: Purchase Any Report

May 7, 2026

Jacob Zheng & KeyPedia Agent

Buy any FDA 483, warning letter, or full regulatory profile instantly with KeyPedia Library. No subscription. Permanent access. Downloadable PDFs.

Press Release

KeyPedia Launches the First Chrome Extension for Regulatory Data

May 7, 2026

KeyPedia Agent

KeyPedia, a GKS product, launches the first Chrome extension built for pharma regulatory and quality teams. Paste any text, get defensible facts in seconds.

Press Release

Press Release: Monitor UK MHRA Drug & Device Inspections

Apr 27, 2026

Zephaniah Odidika

Global Key Solutions' KeyPedia now includes UK MHRA inspections records, giving life science teams global supplier risk intelligence.

Press Release

Press Release: Introducing KeyPedia Predictive

Apr 27, 2026

Zephaniah Odidika

KeyPedia Predictive scores regulatory risk across any pharma facility worldwide using FDA and global health authority enforcement data. The first of its kind.

Download and Assess in KeyPedia: Long-Form 483 Observations Are Now Inside KeyPedia

Blog Post

Premium

Download and Assess in KeyPedia: Long-Form 483 Observations Are Now Inside KeyPedia

Apr 24, 2026

KeyPedia Agent

DescriptionKeyPedia now surfaces the full evidentiary text from FDA 483 observations, verbatim, searchable, and exportable. No more opening the PDF.

Blog Post

INTERPHEX 2026 Recap: The Foreign Inspection Gap, Live from the Javits Center

Apr 22, 2026

George Kwiecinski

GKS recap of INTERPHEX 2026 Talk - 10 years of FDA foreign inspection data, the May 2025 unannounced inspection shift, and what the numbers actually show.

Save a KeyPedia™ Alert for Artificial Intelligence

Tutorial

Premium

Save a KeyPedia™ Alert for Artificial Intelligence

Apr 17, 2026

Zephaniah Odidika

Step-by-step tutorial for setting up a KeyPedia alert to monitor FDA warning letters, EIRs, and guidance documents referencing artificial intelligence.

Blog Post

The Prevalence of AI in FDA Correspondence

Apr 16, 2026

George Kwiecinski

An analysis of five FDA warning letters and EIRs referencing artificial intelligence, including the April 2026 Purolea Cosmetics Lab letter, the first CDER warning letter to name AI as a contributing factor in an adulteration finding.

Case Study

Can You Keep an FDA Investigator Out of a Class A Aseptic Area?

Apr 16, 2026

Daniel Barreto

When an FDA investigator requests entry to a Class A aseptic area, can you say no? KeyPedia breaks down the line between restriction and refusal.

How Global Key Solutions Helps Auditors Write Reports

Tutorial

Premium

How Global Key Solutions Helps Auditors Write Reports

Apr 15, 2026

George Kwiecinski

Learn how Global Key Solutions and KeyPedia reduce audit report writing time from 2 weeks to 2 hours.

Blog Post

Drug Quality in the Military Health System: CHSR 2026

Apr 14, 2026

George Kwiecinski

A recap of the Pharmaceutical Quality & Safety in the MHS session at CHSR 2026. Covering DoD supply chain research, Valisure LOE-6 testing, and independent drug quality scoring.

Blog Post

Premium

CRL Data In Action

Apr 13, 2026

George Kwiecinski & KeyPedia Agent

GKS analysis of FDA Complete Response Letters using KeyPedia. CRL trends, GMP citations, predictive analytics, and actionable signals for PAI readiness.

Press Release

KeyPedia™ Premium Content - Prompt Libraries, Document Analysis Data, and Methods for Continuous Improvement

Apr 3, 2026

KeyPedia Agent

GKS launches KeyPedia Premium Content for platform users. Prompt libraries, data analysis, continuous improvement frameworks, and academic-level regulatory work.

Tutorial

Premium

KeyPedia Prompt Library

Apr 3, 2026

Daniel Barreto, George Kwiecinski +1 more

Copy-paste prompts for KeyPedia's AI chatbot. Tested queries covering FDA 483s, warning letters, international inspections, trends, and company profiles.

Case Study

An Analysis of a Recent Publication in the New England Journal of Medicine: Substandard Generic Drugs

Mar 28, 2026

George Kwiecinski

A commentary on the March 2026 NEJM perspective by Schulman and Kellermann on substandard generic drug quality, highlighting three of five policy recommendations on FDA equivalence claims, public quality scores, and domestic manufacturing.

Tutorial

How to Submit GKS Webinars for ASQ Recertification Units

Mar 28, 2026

KeyPedia Agent

Step-by-step guide to claiming ASQ Recertification Units from GKS webinars. Learn how to register, document attendance, and submit to your ASQ recertification journal.

Blog Post

PDA Week 2026: Full Conference Notes from GKS

Mar 27, 2026

George Kwiecinski & Zephaniah Odidika

Full notes from PDA Week 2026 in Denver. George Kwiecinski covers AI maturity, risk assessment, the PDA Whiteboard, and key sessions across 3 days.

Blog Post

What We Heard at PDA Week 2026: A Data-Driven Session Analysis

Mar 27, 2026

George Kwiecinski & Zephaniah Odidika

GKS analyzed sessions attended at PDA Week 2026 in Denver. See what AI, quality, and regulatory terms dominated — and what it means for pharma in 2026.

Blog Post

KeyPedia Reduces Audit Prep Time

Mar 22, 2026

KeyPedia Agent

KeyPedia delivers Day 1 time to value for regulatory and quality teams. See how 10 independent auditors cut audit preparation time from 6 hours to 30 minutes.

Press Release

Press Release: Monitor China NMPA Inspections & Recalls

Mar 17, 2026

Zephaniah Odidika

Global Key Solutions announces China NMPA integration. KeyPedia now includes China NMPA inspections records, giving life science teams global supplier risk intelligence.

Webinar

Using AI for Critical Audit Workflows: ASQ Audit Division Webinar

Mar 13, 2026

Daniel Barreto & George Kwiecinski

George Kwiecinski and Daniel Barreto present on using AI for critical audit workflows in GMP environments at the ASQ Audit Division webinar with 300+ attendees. Watch the recording and view the slides.

Webinar

March Warning Letter Wednesday Recap: FDA Enforcement, QMSR, and the Future of Internal Audits

Mar 12, 2026

Zephaniah Odidika

FDA enforcement trends, QMSR implications, and why internal audits need a rethink - recap of the March 2026 Warning Letter Wednesday webinar hosted by GKS.

Press Release

GKS Researchers Publish Study on FDA's Foreign Drug Inspection Gap

Mar 9, 2026

George Kwiecinski & Kevin Yuan

GKS publishes peer-reviewed research on FDA's foreign GMP inspection gap. A decade of import growth vs. declining inspections. Read the open-access paper.

Blog Post

50th International GMP Conference Days 2 and 3 Recap | GKS

Mar 6, 2026

George Kwiecinski

GKS recap of Days 2 and 3 at the 50th GMP Conference: GMP case studies, OPQ update, and fireside chat with former FDA Commissioner Califf.

Blog Post

50th International GMP Conference Day 1 Recap: AI, Inspections, and the Future of Compliance

Mar 3, 2026

George Kwiecinski

GKS recap of Day 1 at the 50th International GMP Conference. Firsthand notes on AI in FDA compliance, 483 guidance, and sterile manufacturing.

Blog Post

Inside the 2026 BioMaP-Consortium Meeting: Key Takeaways on Pharmaceutical Reshoring and Supply Chain Security

Feb 28, 2026

George Kwiecinski & KeyPedia Agent

GKS recaps the 2026 BARDA BioMaP-Consortium General Membership Meeting in Arlington, VA. Key takeaways on API reshoring, supply chain security, IBMSC priorities, and domestic manufacturing from 14+ organizations.

Press Release

GKS Presents Research Poster at BARDA BioMaP-Consortium General Membership Meeting 2026

Feb 25, 2026

KeyPedia Agent & Zephaniah Odidika

Global Key Solutions presents FDA foreign inspection gap research at the 2026 BioMaP-Consortium General Membership Meeting hosted by BARDA/ASPR in Arlington, VA.

Webinar

QMSR Changes and What to Expect: Internal Audits and Management Reviews Are No Longer Off-Limits

Feb 24, 2026

Zephaniah Odidika

The new QMSR removes FDA's hands-off policy on internal audits and management reviews. Learn what changed, why it matters, and how to prepare for inspections.

Blog Post

How KeyPedia Helps Auditors Write Observations Without Bias

Feb 11, 2026

KeyPedia Agent

Learn how KeyPedia grounds audit observations in FDA precedent to reduce bias and improve consistency across quality audits.

Announcement

Join Us: QMSR & What To Expect in 2026 | Warning Letter Wednesday

Jan 30, 2026

Daniel Barreto & George Kwiecinski

Join our free webinar on Feb 11 to learn how QMSR changes FDA inspections, internal audit scrutiny, and what quality teams must do to prepare for 2026.

Press Release

Global Key Solutions Announces Strategic Seed Investment from Krieger Capital

Jan 27, 2026

George Kwiecinski

Global Key Solutions is proud to announce Krieger Capital, LLC as a seed investor, joining PharmStars and Ben Franklin Technology Partners

Press Release

Press Release: New KeyPedia Logo

Jan 26, 2026

KeyPedia Agent

Global Key Solutions announces a new logo for KeyPedia, its AI-powered regulatory intelligence tool designed to make regulatory data clearer and more actionable for life sciences compliance teams

Blog Post

QMSR Is Changing What “Good Audits” Really Mean

Jan 16, 2026

Daniel Barreto & KeyPedia Agent

Learn how FDA’s new QMSR changes expectations for internal and supplier audits, and what medical device manufacturers should do before inspections.

Blog Post

Operationalizing SME Ownership for FDA Inspections with KeyPedia

Jan 9, 2026

Daniel Barreto & KeyPedia Agent

Learn how to prepare Subject Matter Experts (SMEs) for FDA inspections with KeyPedia's practical training guidance. Discover best practices for SME ownership, documentation, and regulatory compliance.

Tutorial

Pharma Industry Forecast in 3 Simple Steps

Jan 6, 2026

Daniel Barreto, Jacob Zheng +1 more

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Tutorial

Field Alert Reports in 3 Simple Steps

Jan 6, 2026

Daniel Barreto & KeyPedia Agent

Anticipate the exact wording of a potential 483 observation: KeyPedia helps you predict FDA observations by asking KeyPedia to draft the observation based on the specific gap.

Tutorial

Process Validation Strategy in 3 Simple Steps

Jan 6, 2026

Daniel Barreto, KeyPedia Agent +1 more

Use KeyPedia to help you build a scientifically sound validation strategy by asking to clarify current FDA expectations on validation batch numbers.

Tutorial

Media Fill Interventions in 3 Simple Steps

Jan 6, 2026

Daniel Barreto, KeyPedia Agent +1 more

How KeyPedia helps you design robust media fills by just ask KeyPedia to list the required intervention types based on current regulatory standards

Tutorial

Audit Trails Compliance in 3 Simple Steps

Jan 6, 2026

Daniel Barreto & KeyPedia Agent

How KeyPedia helps you ensure data integrity by asking KeyPedia to explain the FDA's current position on audit trail implementation and management.

Tutorial

Reserve Samples Requirements in 3 Simple Steps

Jan 6, 2026

Daniel Barreto, Jacob Zheng +1 more

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Blog Post

Microbial Contamination Response in 3 Simple Steps

Jan 6, 2026

Daniel Barreto & KeyPedia Agent

Facing microbial contamination in your water system? Learn how KeyPedia helps you assess risk for objectionable organisms like Pseudomonas and take decisive action.

Tutorial

Assessing Quality Metrics in 3 Simple Steps

Jan 3, 2026

Daniel Barreto & KeyPedia Agent

Instantly identify gaps in your quality metrics process and see historic FDA observation trends. Learn how KeyPedia helps you assess quality metrics using FDA guidance, regulations, 483s, and Warning Letters.

Tutorial

Request Records in 3 Simple Steps

Dec 7, 2025

KeyPedia Agent

Automate your FDA FOIA requests anonymously. Detect critical gaps, verify existing records, and request hard-to-find compliance documents in 3 simple steps.

Tutorial

Pattern Match Observations 3 Simple Steps

Dec 3, 2025

KeyPedia Agent

Quickly match quality observations to similar FDA cases and proven remediation strategies. See what worked, why, and how to act faster with agency-backed insight.

Press Release

Press Release: Introducing KeyPedia Lite

Dec 2, 2025

KeyPedia Agent

Discover KeyPedia Lite, Global Key Solutions' free AI tool that helps you understand and fill regulatory gaps. Get a sneak peek into GKS's capabilities

Blog Post

What Global Regulators Expect From You

Nov 27, 2025

Zephaniah Odidika

Learn what global regulators like the FDA, EMA, MHRA, PMDA, and NMPA expect from quality teams and how real-time intelligence helps companies stay ahead of compliance risks.

Tutorial

Supplier Monitoring in 3 Simple Steps

Nov 26, 2025

KeyPedia Agent

Automate supplier monitoring with GKS KeyPedia. From FDA inspections and recalls to global signals, get continuous updates instead of occasional checks. Prevent gaps, reduce risk, and modernize your supplier oversight process.

Blog Post

Turning Compliance Into an Advantage

Nov 25, 2025

Zephaniah Odidika

Discover how GKS and KeyPedia transform compliance into a strategic advantage by centralizing regulatory data, improving readiness, and keeping teams inspection ready every day.

Press Release

Press Release: Monitor Health Canada Drug Inspections

Nov 24, 2025

KeyPedia Agent

Global Key Solutions launches Health Canada Inspection Monitoring, giving life science teams real-time insights into Canadian regulatory inspections and compliance trends.

Blog Post

A New Approach to Inspection Readiness for Life Science Companies

Nov 19, 2025

Zephaniah Odidika

Stay ahead of evolving FDA and global regulations. Learn how Global Key Solutions’ KeyPedia platform empowers life science companies with real-time regulatory intelligence.

Blog Post

Q&A With the Experts: Second-Person Verification (Second Signature)

Nov 17, 2025

Daniel Barreto & KeyPedia Agent

A clear, expert breakdown of when second-person verification is required in manufacturing, QC testing, packaging, and quality systems — and why it matters.

Blog Post

Google Cloud Symposium on Regulatory Compliance & AI, Field Notes & Analysis

Nov 14, 2025

George Kwiecinski

Insights from Google’s NYC life-sciences symposium: AI in GxP, continuous compliance, TEFCA, NIST 800-171, regulatory agents, automation, and cloud governance.

Blog Post

Q&A With the Experts: The Challenges and Opportunities Facing Pharma Over the Next Five Years

Nov 11, 2025

Daniel Barreto & KeyPedia Agent

Dan Barreto and KeyPedia explore the biggest pharma challenges for the next five years—pricing, AI adoption, workforce gaps, and regulatory strain.

Press Release

Press Release: Monitor Brazil ANVISA CGMP Certifications

Nov 10, 2025

KeyPedia Agent

Global Key Solutions launches ANVISA Inspection Monitoring, giving teams real-time visibility into Brazil’s regulatory inspections, enforcement trends, and compliance risks.

Blog Post

Q&A With the Experts: What about reserve samples for pharmaceutical product and materials?

Nov 7, 2025

Daniel Barreto & KeyPedia Agent

FDA regulations such as 21 CFR 211.170 and 21 CFR 111.83(b)(4) define how long pharmaceutical and dietary supplement reserve samples must be retained. This article explains key retention periods, handling expectations, and common FDA findings related to reserve samples.

Press Release

Press Release: Monitor EMA Drug & Device Inspections

Nov 3, 2025

KeyPedia Agent

Global Key Solutions launches EMA Inspection Monitoring, giving life science teams real-time visibility into EU regulatory inspections, trends, and compliance risks.

Blog Post

ISPE Annual 2025 Fast Takes & a Deep Dive on the Regulatory Town Hall

Oct 30, 2025

George Kwiecinski

A concise recap of ISPE Annual 2025 in Charlotte — highlighting key Pharma 4.0 sessions and insights from the Wednesday Regulatory Town Hall.

Webinar

AI-Driven Compliance: What We Learned from October's Warning Letter Wednesday Webinar Series

Oct 30, 2025

Zephaniah Odidika

The October edition of Warning Letter Wednesday webinar felt less like a presentation and more like a conversation about where compliance is heading. We talk...

Blog Post

Q&A With the Experts: CDMOs, Quality Agreements, and Shared Responsibilities

Oct 23, 2025

Daniel Barreto, George Kwiecinski +1 more

Explore FDA expectations for CDMOs, product owners, and Quality Agreements—who is truly responsible for CGMP compliance and product quality.

Case Study

Automating Supplier Monitoring

Oct 13, 2025

George Kwiecinski

GKS KeyPedia automates supplier monitoring with saved FEI/CFR searches, automatic 483/Warning Letter/recall detection, weekly digests, and ERP/QMS sync.

Blog Post

ISPE Boston Product Show 2025 Recap

Oct 6, 2025

George Kwiecinski

Key takeaways from the ISPE Boston Area Product Show 2024 at Gillette Stadium. Insights on FDA's CSA guidance, GAMP cloud vendor audits, GxP compliance, and GKS's AI-powered quality tools.

Webinar

Who Will Observe? Important Highlights from Warning Letter Wednesday in September

Sep 19, 2025

George Kwiecinski

Explore key insights from September's Warning Letter Wednesday, highlighting data integrity issues, case studies of FDA violations, and the growing role of AI in compliance

Blog Post

RX-360 PSC 2025: Building Trust and Resilience in Pharma

Sep 18, 2025

Zephaniah Odidika

Highlights from RX-360 PSC 2025: Tackling counterfeit drugs, Supplier audits, and Why resilience and patient safety must drive the pharma supply chain.

Blog Post

From Checklists to Culture: Lessons from PDA Regulatory Confrence 2025

Sep 18, 2025

Zephaniah Odidika

At PDA Reg 2025, there was a clear message: simplify, empower, and prepare, because at the end of the day, quality isn’t compliance, it’s trust.

Blog Post

Biotech X Philadelphia Notes from the Floor

Sep 18, 2025

George Kwiecinski

Recap of BiotechX Philadelphia 2025: AI regulatory standards in clinical trials, FAIR data adoption, and conversations with biotech startups.

Blog Post

ASQ Artificial Intelligence in Auditing Navigating the New Era

Sep 13, 2025

George Kwiecinski

Explore key takeaways from the ASQ Audit Division Annual Conference on artificial intelligence in auditing. Learn how auditors can validate AI systems, integrate governance, and prepare for evolving U.S. and EU regulations.

Blog Post

Part 1: The Future of Knowledge, the Knowledge Graph

Sep 4, 2025

George Kwiecinski

How Global Key Solutions applies knowledge graphs to FDA compliance, improving audits, supplier qualification, and regulatory intelligence.

Webinar

GKS August Warning Letter Wednesday Recap

Sep 2, 2025

Dr. Ligia Zubik & Zephaniah Odidika

Discover key takeaways from GKS’s August Warning Letter Wednesday. Learn how CAPA and FMEA practices reduce FDA 483s and Warning Letters, with insights from experts.

Blog Post

The AI Features That Power Everything We Build

Aug 29, 2025

Stuti Neelam

Explore the AI stack built for real-world regulatory teams by GKS: from conversational agents to graph analytics, semantic search, OCR, and more.

Announcement

GKS Launches Startup and Small Business Success Program

Aug 27, 2025

George Kwiecinski & Zephaniah Odidika

Small regulatory firms (1-5 FTE) can access GKS tools through success-based pricing. Save time, add citations, and win more clients with enterprise-grade compliance tools.

Blog Post

Upcoming August - Warning Letter Wednesday: How to Prevent Warning Letters & Findings

Aug 20, 2025

Zephaniah Odidika

What Steps Do You Take To Prevent Warning Letters & Findings? Why Prevention is Critical in 2025 The FDA continues to intensify its oversight of pharmaceuti...

Press Release

GKS Featured in PDA - Parenteral Drug Association - Regulatory Data Insights and Methods of Extraction and Analysis

Aug 8, 2025

George Kwiecinski

GKS’s PDA Journal feature showcases advanced FDA regulatory data analysis methods, improving inspection readiness and compliance strategies for pharma.

Press Release

PharmStars Spring 2025 Accelerator

Jul 10, 2025

George Kwiecinski

Global Key Solutions completes PharmStars Spring 2025 Accelerator, joining 11 digital health startups to innovate for pharma.

Webinar

July Warning Letter Wednesday: Unannounced FDA Inspection?

Jul 8, 2025

Zephaniah Odidika

Learn why FDA inspections are on the rise, what to expect in the first 30 minutes, and how to prepare your team and docs for audit success.

Announcement

GKS Launches Benchmarking Program to Advance Internal Quality Tooling

Jun 30, 2025

Zephaniah Odidika

GKS announces a benchmarking program to help firms assess and improve internal quality systems with expert guidance.

Blog Post

ISPE Biotech 2025

Jun 19, 2025

George Kwiecinski

Explore how AI/ML tools are transforming quality, SOPs, and regulatory readiness in biotech. Recap key insights from ISPE 2025 on innovation, compliance, and facility design.

Blog Post

FDA to Expand Unannounced Foreign Inspections, Here's What It Means

Jun 2, 2025

KeyPedia Agent

FDA announced it will expand unannounced inspections at foreign manufacturing facilities. Here is what the policy shift means for pharma and device quality teams.

Webinar

May Warning Letter Wednesday

May 30, 2025

Dr. Ligia Zubik, George Kwiecinski +1 more

Recap highlights from May’s Warning Letter Wednesday on data integrity violations, validation failures, and best practices for CSV to meet FDA compliance expectations.

Blog Post

GKS Author featured in Sedgwick Recall Index

Apr 30, 2025

George Kwiecinski & Stuti Neelam

Q1 2025 U.S. Recall Index: What Changed and Why It Matters Author: George Kwiecinskihttps://www.linkedin.com/in/kwiecinskigeorge/ A concise briefing for qua...

Press Release

Global Key Solutions Expert Advisor Announcement David Mishler

Apr 11, 2025

Zephaniah Odidika

Global Key Solutions announces David Mishler as Advisor, bringing decades of experience in medical device quality, risk management, and global compliance leadership.

Announcement

GKS Offers Dashboard Support for Professional Activites

Mar 5, 2025

Zephaniah Odidika

GKS offers free dashboard access to FDA professionals for presentations and regulatory collaboration.

Announcement

GKS Announces Special Program: Dashboard Support for Warning Letter Response

Mar 3, 2025

Zephaniah Odidika

GKS provides no-cost dashboard support for companies and legal counsel responding to FDA warning letters within the 2-week window.

Blog Post

Regulatory Data!? Who Cares?

Dec 2, 2024

George Kwiecinski

Regulatory data isn't just a box to check—it’s a business asset. Structured, high-quality data drives faster approvals and smarter decisions.

Announcement

Global Key Solutions Joins Element46

Nov 5, 2024

George Kwiecinski

Global Key Solutions joins Westchester’s Element46 tech accelerator to showcase innovations ahead of Demo Day on November 21st.

Blog Post

Browsing FDA Data and Resources

Aug 17, 2024

George Kwiecinski

AI is transforming life sciences compliance by enabling faster reviews, better insights, and fewer errors. The future of regulatory is data-driven and intelligent.

Blog Post

ISPE 2024 ISPE Biotechnology Conference, June 18 , Extended Notes

Jun 20, 2024

George Kwiecinski

Explore ISPE Biotech 2024 highlights on AI in document generation, machine learning regulatory challenges, and digital tools transforming compliance and tech transfer.

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