Category: Med Device Best Practices

How to Do Risk Assessment of IT Networks for FDA compliance

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With the complexity of today’s IT infrastructure and the applications running on networks there is always a risk that something goes wrong. Consequences can be a significant loss of revenue because of production stops, potential safety or health problems if inaccurate data transfer led to inaccurate reporting of laboratory results with consequent inadequate releases of Read more about How to Do Risk Assessment of IT Networks for FDA compliance[…]

Risk management of existing(Legacy) systems for FDA Compliance

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Risk management of existing systems is just as important as for new systems. The question is not: how old is the system? But rather: what is it being used for? You may also ask yourself what happens if something goes wrong and what is the likelihood that something does go wrong.  The main difference for Read more about Risk management of existing(Legacy) systems for FDA Compliance[…]

How to do risk assessment of Spreadsheet and Macros

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Spreadsheet calculations are popular in all kinds of businesses. Macro programs are used to add functionality to standard programs and to automated processes. Results generated by Macro and Spreadsheet (M&S) calculations are frequently used to make business decisions. M&S are also frequently used in regulated environments, for example batch releases in pharmaceutical manufacturing can be Read more about How to do risk assessment of Spreadsheet and Macros[…]

How to do Risk Management of Computer Systems Used for FDA Compliance

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Computers are used throughout pharmaceutical research, development, clinical trials and manufacturing. They are used to control equipment and acquire and evaluate data. Data generated by computer systems are used to make decisions whether or not to release drugs into the market and to release batches of finished products for shipment. Not being able to ship Read more about How to do Risk Management of Computer Systems Used for FDA Compliance[…]

How to create Risk Management Master Plan For FDA Regulated Companies

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The Risk Management Master Plan aims to ensure efficient and uniform execution of risk assessment and control procedures throughout the organization, aligning with regulatory standards, customer expectations, quality benchmarks, and business objectives. It also emphasizes the importance of comprehension and adherence to the company’s risk management protocols across all levels of the organization. This comprehensive Read more about How to create Risk Management Master Plan For FDA Regulated Companies[…]

FDA Inspectors’ Inspection Checklist & Method of Compliance for CAPA Inspection – Med Devices

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FDA inspection is one of the critical elements of FDA’s role in ensuring high quality products are comings to market which does not pose a threat to public. To ensure it FDA inspects various drug and device manufacturing facilities and reviews the systems and processes time to time. These are various regulations and guidance documents Read more about FDA Inspectors’ Inspection Checklist & Method of Compliance for CAPA Inspection – Med Devices[…]

FDA Recall Process & Policies

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The recall of a defective or possibly harmful consumer product often is highly publicized in newspapers and on news broadcasts. This is especially true when a recall involves foods, drugs, cosmetics, medical devices, and other products regulated by FDA. Despite this publicity, FDA’s role in recall activities is often misunderstood not only by consumers, but Read more about FDA Recall Process & Policies[…]

When do we need 510(K) ?

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510(K) is required under following conditions. Introducing a device into commercial distribution for the first time Different intended use for a device already in commercial distribution Indicated by claims made for a device in labeling/advertising Note: Prescription use to over-the-counter use is a major change in intended use Change to a device that could significantly Read more about When do we need 510(K) ?[…]

Best Practices of CSV & 21 CFR Part 11 Compliance

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The cost of compliant CSV can be as much, if not more than the remaining tasks required for system development and implementation. A balance must be reached in order to achieve compliance while minimizing cost of CSV. There are specific industry best practices for effectively controlling the cost of system validation. The cost of longer-term Read more about Best Practices of CSV & 21 CFR Part 11 Compliance[…]

Data Integrity & 21 CFR Part 11 Compliance Requirements

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21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using: Electronic records (ER), and electronic signatures (ES). Each title of the CFR addresses a different regulated area: 21 CFR relates to Pharmaceuticals and Medical Devices. Part 11 Read more about Data Integrity & 21 CFR Part 11 Compliance Requirements[…]