Compliance Architects
@comparchitects.bsky.social
Compliance Architects® helps companies build and maintain sustainable FDA compliance outcomes.
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
December 30, 2025 at 1:10 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
Lighting the way to joy and peace this #Hanukkah. Happy Hanukkah from Compliance Architects! #ComplianceArchitects
December 25, 2025 at 2:15 PM
Lighting the way to joy and peace this #Hanukkah. Happy Hanukkah from Compliance Architects! #ComplianceArchitects
Merry Christmas from Compliance Architects! Wishing you a season of happiness and success. #MerryChristmas #ComplianceArchitects
December 25, 2025 at 1:15 PM
Merry Christmas from Compliance Architects! Wishing you a season of happiness and success. #MerryChristmas #ComplianceArchitects
FDA’s QMSR is coming. Learn how it can strengthen quality systems and how your team can prepare: compliancearchitects.com/qm...
December 24, 2025 at 1:05 PM
FDA’s QMSR is coming. Learn how it can strengthen quality systems and how your team can prepare: compliancearchitects.com/qm...
QMSR compliance prep starts now. Explore strategies to help your organization align with FDA expectations: compliancearchitects.com/qm...
December 17, 2025 at 1:05 PM
QMSR compliance prep starts now. Explore strategies to help your organization align with FDA expectations: 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
December 16, 2025 at 1:10 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
DA’s move from QSR to QMSR brings key changes for device makers. Learn what’s new and how to prepare: compliancearchitects.com/qm...
December 10, 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...
Quality and risk management form the backbone of compliance in the pharmaceutical, biotechnology, and medical technology industries. Discover how frameworks such as ICH Q9, ISO 14971, and 21 CFR facilitate a proactive, risk-based approach.
Read here: compliancearchitects.com/qu...
Read here: compliancearchitects.com/qu...
December 9, 2025 at 1:10 PM
Quality and risk management form the backbone of compliance in the pharmaceutical, biotechnology, and medical technology industries. Discover how frameworks such as ICH Q9, ISO 14971, and 21 CFR facilitate a proactive, risk-based approach.
Read here: compliancearchitects.com/qu...
Read here: compliancearchitects.com/qu...
QMSR 2026 is approaching. Learn what the FDA’s new regulation means for your organization and how to prepare: compliancearchitects.com/qm...
December 3, 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...
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
December 2, 2025 at 1:10 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
FDA’s CSA guidance is redefining pharmaceutical quality by shifting from traditional CSV to a risk-based assurance model. Diluks De Silva outlines how CSA streamlines processes while strengthening product and patient safety. Read it here: compliancearchitects.com/cs...
December 1, 2025 at 8:20 PM
FDA’s CSA guidance is redefining pharmaceutical quality by shifting from traditional CSV to a risk-based assurance model. Diluks De Silva outlines how CSA streamlines processes while strengthening product and patient safety. Read it here: compliancearchitects.com/cs...
Giving thanks for another year of partnerships and success! Happy Thanksgiving from all of us at Compliance Architects. #Thanksgiving #ComplianceArchitects
November 27, 2025 at 1:15 PM
Giving thanks for another year of partnerships and success! Happy Thanksgiving from all of us at Compliance Architects. #Thanksgiving #ComplianceArchitects
FDA’s QMSR is coming. Learn how it can strengthen quality systems and how your team can prepare: compliancearchitects.com/qm...
November 26, 2025 at 1:05 PM
FDA’s QMSR is coming. Learn how it can strengthen quality systems and how your team can prepare: compliancearchitects.com/qm...
🛠 Struggling to navigate the QMSR transition? Learn how to align your CAPA processes with ISO 13485 and FDA requirements in our latest blog. A must-read for medical device professionals! compliancearchitects.com/qm...
#QMSR #ISO13485 #FDACompliance #MedicalDevices
#QMSR #ISO13485 #FDACompliance #MedicalDevices
November 25, 2025 at 1:05 PM
🛠 Struggling to navigate the QMSR transition? Learn how to align your CAPA processes with ISO 13485 and FDA requirements in our latest blog. A must-read for medical device professionals! compliancearchitects.com/qm...
#QMSR #ISO13485 #FDACompliance #MedicalDevices
#QMSR #ISO13485 #FDACompliance #MedicalDevices
A strong CAPA program is essential for reducing risk, improving quality, and preventing repeat issues.
Our blog post explores how to make CAPA a strategic driver of sustainable results.
Read more: compliancearchitects.com/th...
Our blog post explores how to make CAPA a strategic driver of sustainable results.
Read more: compliancearchitects.com/th...
November 24, 2025 at 4:05 PM
A strong CAPA program is essential for reducing risk, improving quality, and preventing repeat issues.
Our blog post explores how to make CAPA a strategic driver of sustainable results.
Read more: compliancearchitects.com/th...
Our blog post explores how to make CAPA a strategic driver of sustainable results.
Read more: compliancearchitects.com/th...
QMSR compliance prep starts now. Explore strategies to help your organization align with FDA expectations: compliancearchitects.com/qm...
November 19, 2025 at 1:05 PM
QMSR compliance prep starts now. Explore strategies to help your organization align with FDA expectations: compliancearchitects.com/qm...
Learn how implementing a robust CAPA system can ensure regulatory compliance and drive continuous organizational improvement. compliancearchitects.com/capa/ #compliance #CAPA #excellence
November 18, 2025 at 1:05 PM
Learn how implementing a robust CAPA system can ensure regulatory compliance and drive continuous organizational improvement. compliancearchitects.com/capa/ #compliance #CAPA #excellence
A strong Quality Culture starts with effective CAPA. Learn how to align your teams, strengthen accountability, and drive lasting improvement across your organization.
Read the full article: compliancearchitects.com/bu...
#QualityCulture #CAPA #LifeSciences
Read the full article: compliancearchitects.com/bu...
#QualityCulture #CAPA #LifeSciences
November 17, 2025 at 5:35 PM
A strong Quality Culture starts with effective CAPA. Learn how to align your teams, strengthen accountability, and drive lasting improvement across your organization.
Read the full article: compliancearchitects.com/bu...
#QualityCulture #CAPA #LifeSciences
Read the full article: compliancearchitects.com/bu...
#QualityCulture #CAPA #LifeSciences
Celebrating World Quality Day! Quality is at the heart of everything we do. Let’s keep driving excellence and compliance together. #WorldQualityDay #ComplianceArchitects
November 14, 2025 at 1:15 PM
Celebrating World Quality Day! Quality is at the heart of everything we do. Let’s keep driving excellence and compliance together. #WorldQualityDay #ComplianceArchitects
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...