Month: April 2024

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[…]

Security best practices under HIPAA

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Document Everything – look through the rule, pick out each standard and each implementation specification and create a chart that briefly describes how you are addressing each. – Require and use strong passwords – teach your staff andcoworkers how to create them – Limit systems access to those who absolutely need it for their jobs Read more about Security best practices under HIPAA[…]