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The FDA’s New Draft Guidance

More recently, the FDA has begun seeing data integrity as a major concern to the violations discovered during audits. As a result, the FDA published its new draft guidance, Data Integrity and Compliance with cGMP, in April 2016 with the purpose to provide...

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Departmental Roles of Data Integrity

Adherence to cGMPs is vital to all Life Sciences manufacturers and data integrity is one component that impacts cGMP. A corporation’s data integrity is influenced by everyone at an organization. As a result, it is essential that employees at all levels understand...

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How To Select Date Ranges

Do you know…  Blue Mountain RAM Provides Multiple Ways of Selecting Date Ranges of Records in Queries? Partner with Blue Mountain RAM and learn how to use date ranges for pulling your data. The following examples use the Asset Event Schedule's "Due Date" field, but...

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What Is Data Integrity?

Data integrity is vital to success in cGMP manufacturing. Companies can produce safer and higher quality products when they document reliable, accurate data. However, in order to ensure data integrity in your organization, you must first have a good understanding of...

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