Prepare for an FDA Inspection

6 Steps to Prepare for an FDA Inspection (Don’t Leave it to Chance)

By Deb Bartel,

The FDA called. They’re coming to do an inspection. Yikes! Now what? How do you prepare? We’ve been there. We’ve experienced the FDA Investigator’s arrival, unannounced, ready to inspect our computer systems. It’s intimidating to say the least, especially if this is your first audit. The repercussions of a failed audit can be devastating to your organization. Warning letters are  … Read more



Audit Software Vendors, Audit Execution

How to Audit Software Vendors: Part 2 – Audit Execution and After the Audit

By Deb Bartel,

Welcome to Part 2 of our series on how to audit software vendors. We will focus on the main event – doing the inspection! Before you go any further, make sure you have read How to Audit Software Vendors: Part 1 – Audit Preparation. It goes into detail about what you should be doing to get ready for the audit itself. Audit  … Read more


Audit Software Vendors, Audit Preparation

How to Audit Software Vendors: Part 1 – Audit Preparation

By Deb Bartel,

Welcome to our three part series on how to audit software vendors. In part one, we’ll review the basic processes and preparation activities. Parts 2 and 3 dig into performing the audit itself and leveraging the results. The Vendor Audit Process In general, to audit software vendors, the process is the same for each audit method. Some of the activities may  … Read more


3 Examples of Why You Should Audit Software Vendors for FDA Compliance

3 Examples of Why You Should Audit Software Vendors for FDA Compliance

By Deb Bartel,

Regulatory Agencies, like the FDA and Eudralex require companies to audit software vendors of their critical software and systems. Regulated companies include several industries – Pharmaceuticals, Biologics, Medical Devices, Clinical Studies, and Blood Products – and include organizations that sell in both the US and International markets. Guidance from the FDA states that: “…the manufacturer should consider auditing the vendor’s design and  … Read more


Software Vendor Audit Methods

How to Audit Software Vendors – Which Method is Right for You?

By Deb Bartel,

How do you audit a software vendor? Which is the right method for your company? These are some questions you may be asking yourself. The answer is “it depends”. It depends on lots of things – how much time, money and expertise do you have available for the audit? If you don’t audit your vendor, what are the risks? How critical is the  … Read more


Software Vendor Assessments

The Key To Successful Software Vendor Assessments (Hint: It’s A Checklist!)

By Deb Bartel,

How do you choose a software vendor? And once you do, will they be able to keep you compliant? Which vendor will provide a high quality software product and protect your data? Are they going to be there when you need support? These are just a few of the questions you’re looking to answer when selecting a software vendor. But  … Read more


fda warning letters

Warning Letter Roundup – January 2017

By Deb Bartel,

The FDA sends Warning Letters and 483s to companies who significantly violate FDA regulations. We gather those related to computer system issues so that you can help ensure your organization doesn’t fail an inspection for similar violations. Organizations who received warning letters citing computer system issues: Wockhardt This Warning Letter cites the failure to validate 12 systems. Download this warning letter. Zyno  … Read more


fda guidance, cyber security, medical devices

How Are You Managing Your Postmarket Cybersecurity Vulnerabilities For Medical Devices?

By Deb Bartel,

At the end of 2016, the FDA published Guidance for Industry and FDA Staff, Postmarket Management of Cybersecurity in Medical Devices to inform industry of recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. This guidance emphasizes that manufacturers should monitor, identify and address cybersecurity vulnerabilities and exploits for their medical devices. What is in the FDA Guidance Document: This  … Read more


fda warning letters

Warning Letter Roundup – December 2016

By Deb Bartel,

The FDA sends Warning Letters and 483s to companies who significantly violate FDA regulations. We gather those related to computer system issues so that you can help ensure your organization doesn’t fail an inspection for similar violations. Organizations who received warning letters citing computer system issues: F.P. Rubinstein Y Cia This Warning Letter contains many observations impacting software quality, including failures in  … Read more


WHO global framework, medical devices

Is Your Medical Device Compliant With The Second Draft Of The WHO Global Model Regulatory Framework?

By Deb Bartel,

In mid-2016, the World Health Organization (WHO) published the 2nd draft of Global Model Regulatory Framework for Medical Devices including IVDs. This document is intended to provide guidance to WHO Member States in developing and implementing regulatory controls relating to medical devices to ensure the quality and safety of medical devices. Since many modern medical devices contain software, developers of  … Read more


FDA guidance GMP active pharmaceutical ingredients

Are Active Pharmaceutical Ingredient Manufacturers Compliant With New FDA GMP Guidance?

By Deb Bartel,

In September, the FDA published Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients to provide API manufacturers with recommendations intended to ensure compliance with regulations. What is in the new FDA Guidance: This guidance document, originally published by ICH in 2000, includes recommended best practices for computer systems, such as: Validation System documentation Security Record protection and retention Audit trails  … Read more


EMA Answers 23 Data Integrity FAQs

23 Data Integrity FAQs Answered By The EMA

By Deb Bartel,

Last month, the EMA’s Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group published their answers to 23 frequently asked questions related to Data Integrity and the Data Life Cycle. EMA’s Recommendations This Q&A document provides insight in the EU regulators’ expectations regarding data risk assessment and mitigation; data security, protection, and retention; electronic signatures; electronic data review;  … Read more


PIC/S, data integrity, draft guidance

New from PIC/S: Draft Guidance on Data Integrity

By Deb Bartel,

Earlier this year, the FDA published draft guidance on Data Integrity and Compliance for GMP. And now PIC/S has published a new, draft document Good Practices for Data Management and Integrity to guide manufacturers of medicinal products in complying with GMP and GDP requirements. As a member of PIC/S, the US FDA participated in the development of this guidance. The draft  … Read more


FDA Guidance on Low Risk Devices

Are you complying with the new FDA General Wellness Policy for Low Risk Devices?

By Deb Bartel,

In July 2016, the FDA released Guidance for Industry and FDA Staff – General Wellness: Policy for Low-Risk Devices to clarify compliance policies for low risk products that promote a healthy lifestyle. What’s in this FDA guidance document: The purpose of a general wellness product According to this FDA guidance, a general wellness product must Be intended only for general  … Read more


fda compliance data integrity cgmp validation

Are you ready for the FDA guidance on Data Integrity and Compliance?

By Deb Bartel,

The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is intended to address the frequent data integrity issues found during FDA inspection of pharmaceutical and API manufacturing sites. What’s new in this draft FDA guidance document: Clarifications & Definitions of Terms This draft guidance contains clarifications and definitions for the terms  … Read more


csv sqa help with project

Are You Following the FDA Medical Device Cybersecurity Guidance?

By Deb Bartel,

In January the FDA published draft cybersecurity recommendations for marketed medical devices to protect patient safety. What’s new in this draft FDA guidance document: Manufacturer’s Responsibilities This guidance emphasizes that medical device manufacturers should monitor, identify and address cybersecurity vulnerabilities.  This draft FDA document highlights that it is essential for device manufacturers to implement comprehensive cybersecurity risk management programs. These  … Read more


FDA Guidance Interoperable Medical Devices

Are you ready for the FDA guidance on the design of Interoperable Medical Devices?

By Deb Bartel,

If your electronic medical device exchanges data with other devices, you need to read the new draft guidance just published by the FDA.  This document contains recommendations intended to promote the safe and effective exchange of information between devices.  Make sure you and your team are aware of these best practices, so you can incorporate them into your medical device.  … Read more


eudralex annex 16 software validation

Are you complying with the European Commission’s new version of Annex 16?

By Deb Bartel,

In October, a new version of Annex 16 was published due to significant changes in the globalization of pharmaceutical supply chains and the introduction of new quality control strategies. Annex 16 was last published in 2001, so this version has significant improvements. The deadline for compliance with this version of Annex 16 is 15-APR-2016. What’s in this new version: This version  … Read more


fda compliance manufacturing site changes

What do you need to know about the new FDA guidance on Manufacturing Site Changes?

By Deb Bartel,

Recently, the FDA drafted this guidance document to help the medical device industry make decisions around manufacturing site changes. This guidance is intended to help in managing the time frames for changes in manufacturing sites and the associate changes to processes, methods, procedures, qualifications and validations by helping industry predict when an FDA pre-approval inspection is likely to be required for  … Read more