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Pharmaceutical companies are hit year after year with strict regulations and shifting expectations from government organizations. In fact, the number of warning letters administered during failed FDA audits has steadily increased over the last few...
Tags: pharmaceutical, pharmaceutical industry document control, Compliance, regulatory, regulatory compliance
Is your company fully prepared to handle a compliance crisis? Effectively managing this process is no easy task, especially if you’re part of the highly regulated pharmaceutical industry. To make this process less daunting, it’s important to plan...
Due to the rise of remote work policies stemming from the COVID-19 pandemic, in person laboratory auditing has been nearly impossible over the past year. Reacting to these difficulties, the FDA announced in March of 2020 that they would be scaling...
Tags: Compliance, audit, fda audit, laboratory industry
Maintaining regulatory compliance while making a product that provides value to your customers can be a daunting task, especially if you are using outdated, manual methods for quality management. Increasing efficiency and reducing instances of...
Tags: document control, Compliance, document workflow automation, automation, regulatory
If your company is required to adhere to FDA 21 CFR Part 11 compliance, a document management system can make this process simple. However, not every system is built the same, and there are certain features your company should look for in a DMS...
Tags: 21 CFR compliance, Compliance, Document Compliance Software
