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Why is Data Integrity Vital

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech CorporationData Integrity is a point of emphasis for the US FDA.  That means they will always look at your data integrity program. FDA expects that your data integrity program assures the accuracy,...

The Importance of Good Documentation Practices

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®Documentation is a “record” or “evidence” of an event that has happened. In the life-science industry “If it isn’t documented, it didn’t happen”. Good Documentation Practices (GDP) are how you prove it...

Calibration Management Made Easy

Written By: Chandler Conley, Business Development ManagerAccuracy of equipment for testing and measurement is necessary for developing and manufacturing critical products, pharmaceuticals, medical devices and more. If you have a well-organized calibration program, you...

Professional Technical Writing Services

We Have Technical Writers Trained in Good Documentation Practices There’s an industry event happening and you have been invited to present a whitepaper. Now, you need someone who can write the whitepaper for you. You need someone with the appropriate technological...

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