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What is Method Transfer, and Why is it Important?

Written By: Mattew Greer, Technical Writer, PSC Biotech®When bringing new products from one facility to another or from a product development to production environment , understanding the requirements for the transfer of validated analytical methods used for testing...

Procedures, Policies, Protocol, … Oh My

Written By: Mattew Greer, Technical Writer, PSC Biotech®Your cGMP documents must comply with the applicable laws and regulations.  They don’t have to be easy to understand but they should be.  Writing compliant and easy to understand and use documents, that are “good”...

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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