Compliance Architects
@comparchitects.bsky.social
Compliance Architects® helps companies build and maintain sustainable FDA compliance outcomes.
DA’s move from QSR to QMSR brings key changes for device makers. Learn what’s new and how to prepare: compliancearchitects.com/qm...
November 12, 2025 at 1:05 PM
DA’s move from QSR to QMSR brings key changes for device makers. Learn what’s new and how to prepare: compliancearchitects.com/qm...
🌊 Overwhelmed by CAPA chaos? Get the tools you need to navigate your way to effective management! 🛠️
Check out our latest blog: Caught in a CAPA Riptide? 👇
compliancearchitects.com/ca...
#CAPA #QualityManagement #ProcessOptimization
Check out our latest blog: Caught in a CAPA Riptide? 👇
compliancearchitects.com/ca...
#CAPA #QualityManagement #ProcessOptimization
November 11, 2025 at 1:05 PM
🌊 Overwhelmed by CAPA chaos? Get the tools you need to navigate your way to effective management! 🛠️
Check out our latest blog: Caught in a CAPA Riptide? 👇
compliancearchitects.com/ca...
#CAPA #QualityManagement #ProcessOptimization
Check out our latest blog: Caught in a CAPA Riptide? 👇
compliancearchitects.com/ca...
#CAPA #QualityManagement #ProcessOptimization
FSMA compliance starts with prevention—and culture makes it sustainable.
Read Teresa Gorecki’s latest article on how to build a proactive, prevention-first approach to food safety.
👉 compliancearchitects.com/fs...
#FSMA #FoodSafety #Compliance #QualityCulture
Read Teresa Gorecki’s latest article on how to build a proactive, prevention-first approach to food safety.
👉 compliancearchitects.com/fs...
#FSMA #FoodSafety #Compliance #QualityCulture
November 10, 2025 at 1:15 PM
FSMA compliance starts with prevention—and culture makes it sustainable.
Read Teresa Gorecki’s latest article on how to build a proactive, prevention-first approach to food safety.
👉 compliancearchitects.com/fs...
#FSMA #FoodSafety #Compliance #QualityCulture
Read Teresa Gorecki’s latest article on how to build a proactive, prevention-first approach to food safety.
👉 compliancearchitects.com/fs...
#FSMA #FoodSafety #Compliance #QualityCulture
QMSR 2026 is approaching. Learn what the FDA’s new regulation means for your organization and how to prepare: compliancearchitects.com/qm...
November 5, 2025 at 1:05 PM
QMSR 2026 is approaching. Learn what the FDA’s new regulation means for your organization and how to prepare: compliancearchitects.com/qm...
In the blog "Navigating the CAPA Conundrum: Problem Statements and More," Jack Garvey outlines strategies for refining problem statements, eliminating bias, & improving implementation to achieve meaningful compliance improvements. compliancearchitects.com/na... #CAPA #QualityCompliance
November 4, 2025 at 1:05 PM
In the blog "Navigating the CAPA Conundrum: Problem Statements and More," Jack Garvey outlines strategies for refining problem statements, eliminating bias, & improving implementation to achieve meaningful compliance improvements. compliancearchitects.com/na... #CAPA #QualityCompliance
Explore how a strong design control framework ensures successful medical device development and regulatory compliance. Insights by Teresa Gorecki highlight best practices every team should know. compliancearchitects.com/de...
November 3, 2025 at 2:05 PM
Explore how a strong design control framework ensures successful medical device development and regulatory compliance. Insights by Teresa Gorecki highlight best practices every team should know. compliancearchitects.com/de...
This November & December, Compliance Architects is focusing on Building an Effective CAPA System: Tools, Strategies, and Success Stories.
We’ll share insights and proven methods to improve CAPA performance and sustain quality improvement.
#CAPA #QualityManagement #ComplianceArchitects
We’ll share insights and proven methods to improve CAPA performance and sustain quality improvement.
#CAPA #QualityManagement #ComplianceArchitects
November 3, 2025 at 1:15 PM
This November & December, Compliance Architects is focusing on Building an Effective CAPA System: Tools, Strategies, and Success Stories.
We’ll share insights and proven methods to improve CAPA performance and sustain quality improvement.
#CAPA #QualityManagement #ComplianceArchitects
We’ll share insights and proven methods to improve CAPA performance and sustain quality improvement.
#CAPA #QualityManagement #ComplianceArchitects
Using GMPs only as a checklist to design your quality system is not enough. A tailor-made, expertly designed system—not just code compliance—drives real performance, resilience, and inspection readiness. Learn why design matters: compliancearchitects.com/gm...
October 31, 2025 at 1:16 PM
Using GMPs only as a checklist to design your quality system is not enough. A tailor-made, expertly designed system—not just code compliance—drives real performance, resilience, and inspection readiness. Learn why design matters: compliancearchitects.com/gm...
Don’t let compliance challenges haunt you! Happy Halloween from Compliance Architects! #Halloween #ComplianceArchitects
October 31, 2025 at 1:15 PM
Don’t let compliance challenges haunt you! Happy Halloween from Compliance Architects! #Halloween #ComplianceArchitects
Check out our article on why CBD manufacturers should prioritize developing Good Manufacturing Practices, even in the absence of FDA instructions. Learn how GMPs can benefit your CBD business and ensure product quality and safety. compliancearchitects.com/cb... #CBD #GMPs #qualitycontrol
October 28, 2025 at 1:05 PM
Check out our article on why CBD manufacturers should prioritize developing Good Manufacturing Practices, even in the absence of FDA instructions. Learn how GMPs can benefit your CBD business and ensure product quality and safety. compliancearchitects.com/cb... #CBD #GMPs #qualitycontrol
FDA enforcement data from 2025 reveals key shifts in inspection priorities and compliance focus. Learn what the numbers say and how to stay prepared: compliancearchitects.com/fd...
#FDA #RegulatoryCompliance #QualityCompliance #LifeSciences #ComplianceArchitects
#FDA #RegulatoryCompliance #QualityCompliance #LifeSciences #ComplianceArchitects
October 27, 2025 at 1:40 PM
FDA enforcement data from 2025 reveals key shifts in inspection priorities and compliance focus. Learn what the numbers say and how to stay prepared: compliancearchitects.com/fd...
#FDA #RegulatoryCompliance #QualityCompliance #LifeSciences #ComplianceArchitects
#FDA #RegulatoryCompliance #QualityCompliance #LifeSciences #ComplianceArchitects
Fun fact: ISO 9001, the international standard for quality management, was first published in 1987! A major milestone in global quality compliance. #NationalQualityMonth #ISO9001
October 24, 2025 at 12:15 PM
Fun fact: ISO 9001, the international standard for quality management, was first published in 1987! A major milestone in global quality compliance. #NationalQualityMonth #ISO9001
In pharma, biotech, and medtech—supplier qualification isn’t a checkbox. It’s a business-critical safeguard.
Learn how a robust qualification process protects product integrity and patient safety.
compliancearchitects.com/su...
#SupplierQualification #LifeSciences #Compliance #MedicalDevices
Learn how a robust qualification process protects product integrity and patient safety.
compliancearchitects.com/su...
#SupplierQualification #LifeSciences #Compliance #MedicalDevices
October 24, 2025 at 12:05 PM
In pharma, biotech, and medtech—supplier qualification isn’t a checkbox. It’s a business-critical safeguard.
Learn how a robust qualification process protects product integrity and patient safety.
compliancearchitects.com/su...
#SupplierQualification #LifeSciences #Compliance #MedicalDevices
Learn how a robust qualification process protects product integrity and patient safety.
compliancearchitects.com/su...
#SupplierQualification #LifeSciences #Compliance #MedicalDevices
FDA’s QMSR is coming. Learn how it can strengthen quality systems and how your team can prepare: compliancearchitects.com/qm...
October 23, 2025 at 12:05 PM
FDA’s QMSR is coming. Learn how it can strengthen quality systems and how your team can prepare: compliancearchitects.com/qm...
In life sciences, supply chain efficiency and acquisition integration drive success. Strategic planning and data-driven insights are key.
Learn more: compliancearchitects.com/su...
#SupplyChainOptimization #LifeSciences #AcquisitionIntegration
Learn more: compliancearchitects.com/su...
#SupplyChainOptimization #LifeSciences #AcquisitionIntegration
October 21, 2025 at 12:05 PM
In life sciences, supply chain efficiency and acquisition integration drive success. Strategic planning and data-driven insights are key.
Learn more: compliancearchitects.com/su...
#SupplyChainOptimization #LifeSciences #AcquisitionIntegration
Learn more: compliancearchitects.com/su...
#SupplyChainOptimization #LifeSciences #AcquisitionIntegration
May your Diwali shine bright with happiness, success, and prosperity! Wishing you light and joy from Compliance Architects. #Diwali #ComplianceArchitects
October 20, 2025 at 9:28 PM
May your Diwali shine bright with happiness, success, and prosperity! Wishing you light and joy from Compliance Architects. #Diwali #ComplianceArchitects
FDA’s new guideline expands the use of alternative tools to assess drug manufacturing facilities. Learn how this impacts compliance, quality, and operations: compliancearchitects.com/al...
#FDA #DrugManufacturing #PharmaCompliance #QualitySystems #ComplianceArchitects
#FDA #DrugManufacturing #PharmaCompliance #QualitySystems #ComplianceArchitects
October 20, 2025 at 2:35 PM
FDA’s new guideline expands the use of alternative tools to assess drug manufacturing facilities. Learn how this impacts compliance, quality, and operations: compliancearchitects.com/al...
#FDA #DrugManufacturing #PharmaCompliance #QualitySystems #ComplianceArchitects
#FDA #DrugManufacturing #PharmaCompliance #QualitySystems #ComplianceArchitects
In life sciences, supply chain chaos is now the default.
📦 CGTs & RLTs demand cold-chain precision.
⚠️ Old models of efficiency won’t survive.
💡 Resilience = your new edge.
Explore the strategy: compliancearchitects.com/su...
#SupplyChainResilience #CGT #BiopharmaLogistics
📦 CGTs & RLTs demand cold-chain precision.
⚠️ Old models of efficiency won’t survive.
💡 Resilience = your new edge.
Explore the strategy: compliancearchitects.com/su...
#SupplyChainResilience #CGT #BiopharmaLogistics
October 17, 2025 at 12:06 PM
In life sciences, supply chain chaos is now the default.
📦 CGTs & RLTs demand cold-chain precision.
⚠️ Old models of efficiency won’t survive.
💡 Resilience = your new edge.
Explore the strategy: compliancearchitects.com/su...
#SupplyChainResilience #CGT #BiopharmaLogistics
📦 CGTs & RLTs demand cold-chain precision.
⚠️ Old models of efficiency won’t survive.
💡 Resilience = your new edge.
Explore the strategy: compliancearchitects.com/su...
#SupplyChainResilience #CGT #BiopharmaLogistics
Flashback: The 1950s saw the rise of Total Quality Management (TQM), championed by Deming and Juran. Their legacy lives on in continuous improvement practices today! #NationalQualityMonth #QualityLeadership
October 17, 2025 at 12:05 PM
Flashback: The 1950s saw the rise of Total Quality Management (TQM), championed by Deming and Juran. Their legacy lives on in continuous improvement practices today! #NationalQualityMonth #QualityLeadership
QMSR compliance prep starts now. Explore strategies to help your organization align with FDA expectations: compliancearchitects.com/qm...
October 16, 2025 at 12:05 PM
QMSR compliance prep starts now. Explore strategies to help your organization align with FDA expectations: compliancearchitects.com/qm...
Luis Walter Alvarez’s innovations in physics and instrumentation set the stage for today’s data-driven approach to quality.
#HispanicHeritageMonth #ComplianceArchitects
#HispanicHeritageMonth #ComplianceArchitects
October 15, 2025 at 12:05 PM
Luis Walter Alvarez’s innovations in physics and instrumentation set the stage for today’s data-driven approach to quality.
#HispanicHeritageMonth #ComplianceArchitects
#HispanicHeritageMonth #ComplianceArchitects
What can recent FDA Warning Letters teach us?
From recurring GCP failures to sponsor oversight gaps—2024–2025 enforcement actions reveal clear risks.
We break down the patterns and share proactive strategies to stay inspection-ready.
compliancearchitects.com/re...
#WarningLetters #ClinicalTrials
From recurring GCP failures to sponsor oversight gaps—2024–2025 enforcement actions reveal clear risks.
We break down the patterns and share proactive strategies to stay inspection-ready.
compliancearchitects.com/re...
#WarningLetters #ClinicalTrials
October 14, 2025 at 12:05 PM
What can recent FDA Warning Letters teach us?
From recurring GCP failures to sponsor oversight gaps—2024–2025 enforcement actions reveal clear risks.
We break down the patterns and share proactive strategies to stay inspection-ready.
compliancearchitects.com/re...
#WarningLetters #ClinicalTrials
From recurring GCP failures to sponsor oversight gaps—2024–2025 enforcement actions reveal clear risks.
We break down the patterns and share proactive strategies to stay inspection-ready.
compliancearchitects.com/re...
#WarningLetters #ClinicalTrials
Quality isn’t just about compliance—it’s a growth driver.
Discover how life sciences companies can transform their quality systems into a competitive advantage in our latest blog.
Read more: compliancearchitects.com/qu...
Discover how life sciences companies can transform their quality systems into a competitive advantage in our latest blog.
Read more: compliancearchitects.com/qu...
October 13, 2025 at 12:30 PM
Quality isn’t just about compliance—it’s a growth driver.
Discover how life sciences companies can transform their quality systems into a competitive advantage in our latest blog.
Read more: compliancearchitects.com/qu...
Discover how life sciences companies can transform their quality systems into a competitive advantage in our latest blog.
Read more: compliancearchitects.com/qu...
Check out our blog post by Jack Garvey on the costly consequences of adulterated drugs and the need for more vigorous regulatory enforcement. Learn about the impact on public health and how we can prevent it. compliancearchitects.com/co... #DrugSafety #RegulatoryEnforcement
October 10, 2025 at 12:06 PM
Check out our blog post by Jack Garvey on the costly consequences of adulterated drugs and the need for more vigorous regulatory enforcement. Learn about the impact on public health and how we can prevent it. compliancearchitects.com/co... #DrugSafety #RegulatoryEnforcement
Fun fact: Modern quality systems owe much to Walter Shewhart’s 1920s innovations in statistical quality control! His work still shapes compliance practices today. #NationalQualityMonth #QualityHistory
October 10, 2025 at 12:05 PM
Fun fact: Modern quality systems owe much to Walter Shewhart’s 1920s innovations in statistical quality control! His work still shapes compliance practices today. #NationalQualityMonth #QualityHistory