How Adopting an eLog Solution Helps with Regulatory Compliance

 

The pharmaceutical industry has zero tolerance when it comes to ensuring the quality of drug produced. The reason behind that is quite obvious, since even a slight deviation from the desired product can have devastating repercussions on a mass level.

The US Food and Drug Administration (FDA) has put in place certain regulatory guidelines that need to be adhered to in order to release a product into the market. In the 1990s, the regulatory body put in place a framework called ALCOA, that serves as a checklist to help with regulatory compliance. Shortly after that, FDA released a section known as 21 CFR Part 11, with the intent to help pharmaceutical companies maintain data integrity while utilizing modern technology, by ensuring all information verified through these systems check all the boxes for regulatory compliance.

Although these two frameworks were introduced in the 1990s, a quick scan of the 483s issued these days clearly points to the fact that several pharmaceutical companies struggle to meet FDA’s regulatory guidelines even today.

Most pharmaceuticals finding it difficult to adhere to FDA guidelines could benefit from solutions compliant with the aforementioned concepts and GMP. A simple way any pharma company can ensure regulatory compliance is by adopting a high-quality eLog solution.

What is an eLog?

Simply put, an eLog management solution digitizes your area and equipment logs, enabling you to verify or review them online.

It helps you capture data and details of a batch, people involved and time of an activity from an area/equipment as and when it happens, storing and preserving your logs electronically, which can be searched and retrieved at any time.

It also helps you organize your data and presents it in the form of reports that are easy to comprehend.

eLogs allow you to cut down on costs incurred in printing, storing and retaining documents and makes managing your audit easy. You can store your data securely, accessing it any time you wish to and it helps you become more sustainable by completely eliminating the use of paper.

How can an eLog solution help you with compliance? Let’s find out. For more information, Visit https://www.pharmision.barcodeindia.com/blogs/how-adopting-an-elog-solution-helps-with-regulatory-compliance/

Single Label: Replacing Traditional Methods Using Barcode Technology

 

Traditional pharmaceutical manufacturing is a complex process that involves applying multiple labels on containers to understand their status at any given point in time.

A label is applied on every material that comes in, which is subsequently replaced or additional labels applied at every stage of operations. The label affixed usually displays details of the type of material, the stage in which it is at, its approval status, the users handling it, timestamps, etc.

Once the item moves from one stage to another, a fresh label is applied to it, showing all pertinent details of the current stage.

The use of multiple labels at every stage, however, poses a bunch of problems. Here are some common problems with the multiple label approach:

Illegibility: The details are usually handwritten, so legibility is sometimes an issue. There might be occasions where what is written on a label is not clear, in which case, there is a lot of back and forth to cross-check the details.

Human error: Since the labels are manually entered and placed, there is always a chance of human error such as incorrect entries, missing entries/signatures, affixing wrong labels on a container, and even missing labels altogether at times, which can cause several drastic issues down the line.

High printing costs: At each new stage, a fresh label has to be printed for a set of containers. Now, at any given point in time, there might be hundreds of such items for which new labels are to be printed for each stage. That becomes cumbersome and involves lots of labels to be printed and increased usage of stationery and driving up printing costs.

The effort involved: In a traditional setup, the responsible person has to go to a printing station, get a fresh label printed, contents of which are to be verified by the person who prints, get a doer-and-checker sign-off, and apply them on each of the containers. And this process is repeated every time the status of the material changes (quarantine to sample test to release/rejected). Moreover, in a multiple-label setup, extra effort is needed in color coding the labels and ensuring the availability of ample stationery. It also entails locating the containers in the warehouse and bringing down containers placed at a height, applying labels and placing them back at times. This complicates the workflow, as there is a tremendous amount of effort required. For more details visit https://www.pharmision.barcodeindia.com/blogs/single-label-replacing-traditional-methods-using-barcode-technology/