ERP for Pharmaceutical Industry: Comply with FDA and GMP Standards

ERP for Pharmaceutical Industry: Comply with FDA and GMP Standards

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Sarah, a quality control manager at a mid-sized pharmaceutical company, is staring at a tall collection of paper batch records spread across her desk. It's around 7 PM, and she's still at the office trying to find a missing signature on an important production batch that needs to ship tomorrow. Also, her team has been struggling with compliance documentation for months, which is missing paperwork, pending approvals, misplaced documents, and illegible handwriting, which has all become so common. Just last week, during an FDA audit, it took her team three days to compile all the required documentation. As she rubs her tired eyes, Sarah thinks about how her colleague Mark at another pharma company recently mentioned their new ERP for pharmaceutical industry. "We haven't missed a single document since implementation," he had said. "And our last FDA audit? We showed up every record they asked for within minutes."

It's not only Sarah's story; it is a common challenge for a number of manufacturers in the pharmaceutical industry today. They face challenges in maintaining strict compliance with FDA and GMP standards, which made them realize that traditional paper-based approaches can't be applied anymore.

The solution? Implementation of ERP for the pharmaceutical industry. In this article, we will explore how the FDA and GMP standards ERP solution helps in complying with FDA and GMP standards.

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