• ISO 17025 vs ISO 9001 – how are they different?

    Posted March 1st, 2023 By Mukut Chakraborty

    ISO 17025 vs ISO 9001 – both standards are for quality management systems, but they have different purposes. The purpose of this article is to explain the difference between these two standards. This article will also explain how you can use them together for greater efficiency. What is ISO 9001? The International Organization for Standardization, […]

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  • What are 21 CFR 211.198, 21 CFR 211.167, 21 CFR 211.180, and 21 CFR 211.194?

    Posted February 8th, 2023 By Mukut Chakraborty

    21 CFR 211.198, 21 CFR 211.167, 21 CFR 211.180, and 21 CFR 211.194 are four regulations that govern the manufacturing of pharmaceuticals and medical devices in the United States by defining how to store, test and produce them safely. These regulations were established by the Food and Drug Administration (FDA) under the authority given to […]

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  • How to start a career as an ISO 9001 consultant

    Posted January 11th, 2023 By Mukut Chakraborty

    It’s important to understand that becoming an ISO 9001 consultant can be both challenging and rewarding. It takes hard work and dedication to get this designation, but once you’ve done it and become certified in the field, you may find yourself with a lot more options for your career path.  Now you can watch this […]

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  • ISO 9001 section 8.4 – everything you need to know

    Posted December 21st, 2022 By Mukut Chakraborty

    Now you can watch this blog too! ISO 9001 section 8.4 is related to supplier management and it’s one of the most important sections in the ISO 9001 standard. ISO 9001:2015 has brought in a lot of changes and supplier management is one of them. Gone are those days when it used to be only […]

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  • How to prepare employees for ISO audit

    Posted October 19th, 2022 By Mukut Chakraborty

    Introduction How to prepare employees for ISO audit is the most common question we come across. The ISO audit is a critical part of your business’s international standards strategy. It’s an opportunity for your organization to demonstrate that it meets the requirements set by the International Organization for Standardization (ISO) and other regulatory authorities. An audit […]

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  • 21 CFR 820 Nonconforming Product – All you need to know

    Posted September 28th, 2022 By Mukut Chakraborty

    Introduction When we think of a 21 CFR 820 Nonconforming Product, the first thing that comes to mind is a consumer who has been injured by a defective product. But did you know that many nonconforming products are not defective? The term “nonconformance” refers to any deviation from the requirements of 21 CFR 820. This […]

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  • How to Choose the Best QMS

    Posted August 26th, 2021 By Mukut Chakraborty

    One of the biggest challenges of running a business is the sheer number of regulations that must be followed to bring your service or product to market. Paperwork and reporting requirements using the wrong QMS can make quality management difficult and costly. Requirements can vary by a multitude of factors, such as region, consumer demands, […]

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  • Improving MDSAP Audit Efforts with Automation

    Posted November 30th, 2020 By Mukut Chakraborty

    The Medical Device Single Audit Program (MDSAP), enables auditing organizations recognized by the MDSAP to conduct one regulatory audit or medical device manufacturers that satisfies the requirements associated with the participating authorities of the program.

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  • Improving Organizational Efficiency With 3×5 Why Analysis

    Posted August 11th, 2020 By Mukut Chakraborty

    Companies that are committed to quality are always looking for ways to improve. When a process is running smoothly, they explore new ways of enhancing workflow. When something breaks down, they take extra steps to ensure a clear

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  • Remotely Managing Risks With PFMEA

    Posted May 13th, 2020 By Mukut Chakraborty

    Finding ways to optimize quality control is important. In fact, it should be one of the top priorities of all high-performing companies. Even the smallest companies are now competing against big corporations. Therefore, ensuring that one’s products are always of optimal quality is imperative to the overall success of your company.  Consumers have to be […]

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  • All About FDA 21 CFR Part 11

    Posted May 6th, 2019 By Mukut Chakraborty

    On May 2016, the US Food and Drug Administration (FDA) decided that electronic nicotine delivery systems (ENDS) companies must follow the same rules as tobacco products. It includes:

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  • What Are The GMP Guidelines?

    Posted August 1st, 2018 By Mukut Chakraborty

    GMP stands for Good Manufacturing Practices, it is a compliance standard in production and manufacturing industries. GMP guidelines are aimed at making the production line more consistent and aims to give better control

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  • What You Need to Know About Bill S-5

    Posted April 20th, 2018 By Mukut Chakraborty

    The burgeoning vape industry is about to transform side by side with its exponential rise. As with any new emerging industry, there are always regulations that need to be updated or created in order to better serve its community and the public.

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  • Improve Productivity With TPM Implementation and OEE

    Posted December 18th, 2017 By amlorriman

    Quality management is a resource-intensive business activity. When implemented properly, it offers a significant return on investment. Many companies that rely on production equipment to manufacture goods have selected the

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  • 5S In The Workplace

    Posted August 22nd, 2017 By amlorriman

    How to Implement 5S In The Workplace Your company’s production and efficiency is dependent on the organization of your work spaces.  Cluttered spaces create risks for employee mistakes, bottlenecks, worker safety, and worker morale. Leaders look to methods such as 5S in the workplace

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