All You Need to Know About ALCOA+

 

The pharmaceutical industry has a history of struggling with data management until the inception of the ALCOA+ 

framework. Its introduction has transformed the way data is recorded and managed today. In an industry where

there is little tolerance for errors and quality deviations, ALCOA+ has proved to be a boon by allowing the industry 

to integrate its data and achieve regulatory compliance.

What is ALCOA+?

ALCOA+ is a system that ensures data integrity in the pharmaceutical manufacturing industry. It is the 

brainchild of Food and Drug Administration (FDA) and its main aim is to integrate data and ensure data security.

Adopting ALCOA+ is essential for compliance to FDA guidelines and GMP practices.

Principles of ALCOA

ALCOA is an acronym that stands for
Attributable
Legible
Contemporaneous
Original
Accurate

The ‘+’ at the end of the word indicates the additional elements that are a part of the system, which are complete, 

consistent, enduring, and available.

In order to benefit from the system, it’s imperative that you have a thorough understanding of each element, which 

will enable you to implement the system successfully and reap its rewards.

So, let’s take a deep dive into the elements that form ALCOA+ and understand each one of them in depth.

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Why GMP is a Must for Pharmaceutical Industry

 

Every industry has its own set of challenges.

For some, ensuring a smooth supply chain is the topmost priority, while for others, the rate of manufacturing could be the most crucial aspect.

When it comes to the pharmaceutical industry, ensuring quality is at the top of that priority list. Maintaining good quality is not possible without a robust plan in place, a set of guidelines to adhere to and a foolproof audit plan.

That is where GMP comes in.

What is GMP?

GMP or Good manufacturing practice is a system that ensures that your products are being manufactured and tested in line with the required quality standards in line with industry best practices.

It is typically ensured through the effective use of a quality management system (QMS) and enables you to implement proper quality control and minimize risks.

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