Data Integrity

Data Integrity – IT Controls

FDA Warning Letters Trends – Part 5

In part 3 and 4 of our series of “Warning Letter Trends” articles covering Raw Data and Records, we concluded that both the behavioral culture and the design of processes and records to support them are crucial to secure compliance to Good Documentation Practices.

In this article, we will cover IT Controls. Failure to secure proper IT Controls may risk random and accidental alteration of raw data and records, leading to the consequences mentioned in the articles Raw Data and Records. Except from adherence...

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Data Integrity – Records

FDA Warning Letters Trends – Part 4

In part 3 of our series of “Warning Letter Trends” articles we concluded that the identification of required raw data within each process is crucial for both product safety and maintaining trust by regulatory authorities; and that this identification of raw data should be based on assessment of critical quality attributes. Dressing employees to succeed with data integrity requires more activities to facilitate the adherence to GXPs.

In this 4th article in our series, we will cover Records....

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Data Integrity – Raw Data

FDA Warning Letters Trends – Part 3

In part 2 of our series of “Warning Letter Trends” articles, we concluded that the reason for not adhering to Good Documentation Practices may not be as simple and obvious as thought at first glance. Human Error may seem the root cause but typically, people fail due to inefficient managerial processes or business process design.  Structured problem solving has proven its effect being an indispensable tool in everyday decisions and fundamental in the way the Life Science Industry work with Quality & Compliance.

In this...

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Data Integrity – Documentation Timeliness

Warning Letter Trends 2015 – Part 2

By: Inge Kuhlmann Goddik, DeltaCo Ltd

In part 1 of our series of “Warning Letter Trends” articles, we concluded that FDA has increased scrutiny of DATA Integrity since 2010. Receiving a Warning Letter followed by an intensive effort to lift the warning letter can be very costly. The time frame to solve issues are short, and require extra resources, in order not to risk lower sales and a product import ban in the US. So being well prepared for the future becomes a competitive advantage. Incorporating a warning letter trend...

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Data Integrity - Back to Basics

FDA Warning Letters Trends – Part 1

By: Inge Kuhlmann Goddik, DeltaCo Ltd.

At DeltaCo we find that the trends of Warning Letters as well as 483 Forms can deliver crucial insights that will help your company better bridge into the future; a helpful tool to forecast focal points of FDA inspections. So why not be ahead of times and constantly assess your GxP temperature, conducting yearly warning letter trend reviews?

Every Life Science company today agrees that Quality & Compliance is not just a matter of License to Operate – it...

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