GxP Lifeline

Showing items tagged as Audit Management

Santa’s Little Auditor

17 December, 2019 by Sarah Beale, Staff Writer, MasterControl

It’s the time of year for parents to pull out the Elf on the Shelf and regale their children with stories of how their behavior gets reported back to Santa. Making sure those reports are accurate depends on whether the elf is using paper or digital solutions.
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It’s A Charlie Brown Audit

19 November, 2019 by David Jensen, Staff Writer, MasterControl

Over the years, Charlie Brown and the Peanuts gang have regaled us with TV specials featuring their own brand of holiday celebrations. One show that never made it to the airwaves was the gang’s experience operating a medical device manufacturing plant that was having an audit. This article describes how that event played out.
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Avoid FDA Audit Findings on Your Device by Performing Process Validation

27 June, 2019 by Dan O'Leary, President, Ombu Enterprises

Medical device makers could save themselves time and heartache in reducing the number of regulatory findings when it comes to the FDA’s CFR Part 820 quality system regulations and ISO 13485. How? By understanding the benefits you get by fully implementing process validation to achieve higher levels of compliance.
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MDSAP: Guiding Your Company Through the Audit Process

26 December, 2018 Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner

Now that you understand what the Medical Device Single Audit Program (MDSAP) is and how it can benefit your medtech company, learn more about MDSAP’s audit process and how to successfully steer your company through the specifics of the journey. This is Part 2 of a three-part blog series about MDSAP.
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FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 2

24 May, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.
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Proving the Effectiveness of Mock FDA Audits

10 May, 2018 by Patricia Santos-Serrao, Director of Product Strategy, MasterControl

A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.
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5 Areas of Focus When Conducting Supplier Audits

2 January, 2018 by David Butcher, Staff Writer, MasterControl

Conducting supplier audits is a well-established way to identify, eliminate and prevent quality problems in a supplier’s products, processes or management system before the problems spread. Still, there are ways to improve supplier audits. In a recent article for Pharmaceutical Manufacturing, MasterControl Senior Product Manager Terrance Holbrook recommended five actions take to to better conduct onsite supplier audits.
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Coping with Scoping a CSV/Part 11 Audit

21 September, 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.
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19 Key Elements to Review for Effective Audits

18 April, 2017 Dr. George L. Harris, DBA, CPM, CPCM, President, Calyptus Group

Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination o
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Quality Audit - A Tool for Continuous Improvement and Compliance

18 April, 2017 Jason Clegg, Marketing Director, MasterControl, Inc.

The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.
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2017 Marks Official “Go Live” For Medical Device Single Audit Program (MDSAP)

2 March, 2017 Marci Crane, Staff Writer, MasterControl

For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of
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Supplier Approval Challenges Under FSMA

1 March, 2017 Erika Miller, Food Safety Specialist, D.L. Newslow & Associates, Inc.

As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog
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The Migraine Known as the Supplier Audit — and Some Simple Remedies

23 February, 2017 Ken Christie, COO, VTS Consultants

The topic of supplier audits can cause severe anxiety and headaches for many biopharma companies. This pain stems from the combination of having to understand the applicable regulations, determine the elements of a supplier audit in terms of criticality, establish the frequency and type of audits to be performed based on this evaluation, and follow-up on any issues found. Sufficient time is needed to prepare for and execute such activities, and time is one thing few of us have enough of. However
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Top 8 Ways to Reach Regulatory Compliance

8 December, 2016 MasterControl

Many companies doing business in regulatory environments treat compliance like another obstacle to success. However, companies that live in regulatory environments have come to understand that compliance is actually a tool that can give them a competitive advantage. Statistics show that 72 percent of senior executives at regulated companies say that ensuring compliance with regulatory requirements is one of the most important challenges in their company.
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If Taylor Swift Were Your FDA Auditor or How to Present Yourself and Your Company During an FDA Audit

23 August, 2016 by Marci Crane, Localization Manager, MasterControl, Inc.

The current data show that an adult is likely to change employment at least a few times during his or her lifetime. Taylor Swift, on the contrary, is one of the rare individuals who most likely will never have to remake her career. However, surprises do happen, and would it be so far-fetched to imagine that at some point in the near future Taylor might take up auditing? And not just any auditing, but auditing for the FDA?
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What, No Internal Audits?

21 June, 2016 Dr. Christopher Joseph Devine, President Devine Guidance International

For the aerospace, defense, automotive, pharmaceutical or medical device industries, it really makes no difference when it comes to auditing the effectiveness of the quality management system (QMS): An established auditing program is a fundamental requirement. ISO 9001, ISO 13485, AS 9100, and the primary topic of most of Dr. D’s rants 21 CFR, Part 820 compliance, all have elements mandating that quality audits be performed. So the doctor always finds it quite disturbing when a device establishment fails to comprehend the importance of creating an audit schedule and actually performing the audits.
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Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

1 December, 2015 Jessica Masarek, Quality Assurance Consultant | Independent Auditor Director, Muse Clinical

Audits and inspections seem to be wrapped in a shroud of mystery, making folks stressed and unsure of exactly what is going to happen. What if I say the wrong thing? What if I don’t know the answer? What if I can’t provide what they are asking for? Realistically, all of these things will probably happen! That said, as long as you are honest, all will be well. Mistakes happen and no auditor or inspector is expecting perfection. We are expecting transparency. As an auditor, my goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data. Sponsors want to continue working with sites in which so much effort has been invested and will work to identify areas for improvement if deficiencies are noted. An inspector has a similar goal with respect to the assessment of trial conduct. So, how do we ensure that trials are run at the level of quality that regulators are looking for and that are truly inspection ready?
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Still Using Paper for Audits? Here’s Why You Need to Automate

27 October, 2015 Steve Harrison, Product Manager, MasterControl

A recent quality management system benchmark survey showed manual processes are still predominant over automated systems.[1] The results of the survey were compiled from over 100,000 professionals worldwide and the majority of the participants work in quality or regulatory positions across pharmaceutical, medical device and biotech industries.
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Multipurpose Tool vs. Best-of-Breed Platform: How to Tell the Difference

15 September, 2015 Paul Sanderson, Solutions Consultants Group Lead

When we invest in tools, we naturally want the most bang for our buck. Who hasn’t tried to use a screwdriver as a pry bar or a pair of pliers for loosening a bolt when a properly sized wrench would be more appropriate?
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What Does Risk-Based Monitoring Mean for QA Auditing?

13 January, 2015 Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants, Inc.

By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed. So what does that mean for quality assurance (QA) teams who audit these new processes? Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.
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