Regulatory Compliance in Pharmaceutical and Drug Delivery Laboratories

Regulatory compliance is one of the most important considerations in pharmaceutical and drug delivery labs. Meeting guidelines such as FDA regulations is crucial not just because it’s legally required, but also to ensure the safety and efficacy of pharmaceutical products that are manufactured in these laboratories.

The Importance of Regulatory Compliance

Importantly, regulations are ultimately there to protect patients and consumers. They demand rigorous testing, documentation, and quality control for a reason - primarily so that unsafe medications aren’t released to the public. Not complying with the necessary regulations can lead to a number of issues, whether it’s a fine, product recall, reputational damage, or all of the above.

Common Pain Points

Many labs find meeting compliance and maintaining it to be a complex and time-consuming process. Common pain points in the process include:

-Manual data entry

-Keeping accurate audit trails

-Managing documents

When vast amounts of data, auditing, and records are involved and the process is manual, it can be challenging not to make errors.

How Automation can Support Compliance

At Astech, we believe that automation can be a powerful tool to simplify your processes and enable you to strengthen your compliance with regulations.

Some ways that automation can assist in the lab are:

-Automated data capture to reduce manual entry
-Creation of electronic records which are easier to manage, more traceable, and easier to audit
-Automatic generation of audit trails by providing a record of all actions performed within a system
-Standard, consistent workflows to eliminate variability in procedures

Our Lab Expert product could play a key role in your lab and support you to streamline your processes, by automating time-consuming compliance tasks such as data capture.