Why Data Integrity is Important for FDA Regulated Companies - Pharmision Barcode India

 

The Food and Drug Administration (FDA) has always stressed the importance of data integrity as part of Good Manufacturing Practice.

Despite that, FDA warning letters issued each year continue to cite it as one of the failures. While the number of citations decreased in the period 2017-2019, it has witnessed an upward surge yet again in recent years.

Although the recent 483s citing data integrity have not reached the figures of close to 80% as witnessed in FY2016, it continues to be a problem that the FDA-governed industry continues to struggle with. Moreover, the deficiencies continue to be the same as they were a decade ago.

It is important to note that FDA has not made any changes to the definitions or regulations or expectations in recent years. There have not been any new guidelines or regulations in the category. This clearly indicates that it is the companies who have not been able to implement the requirements satisfactorily. Read more...

Source Link:- https://www.pharmision.barcodeindia.com/blogs/why-data-integrity-is-important-for-fda-regulated-companies/

Here’s why you should switch to eLogbooks today - Pharmision Barcode India

 

The pharmaceutical industry has been rapidly adopting Pharma 4.0 principles. In case you are not aware of the concept, it is an ISPE initiative that aims to improve the processes throughout the life cycle of pharmaceutical products with the help of modern smart technology in line with the philosophy of Industry 4.0.

Although Pharma 4.0 is currently being considered a source of competitive advantage rather than a must-have, it won’t take too long for it to become an absolute need for the pharmaceutical industry. Eventually, the industry must undergo that transformation, go for that upgrade and embrace Pharma 4.0.

Having said that, upgrading to and implementing Pharma 4.0 does have a cost impact, so most companies are choosing to make small changes at a time and then gradually scaling up before eventually migrating completely to Pharma 4.0.

One great (and inexpensive) first step is adopting an eLogbook solution. Using Electronic Logbooks instead of using paper logbooks has several advantages and it’s easier to embrace advanced technological solutions when you see the results you get by introducing tech solutions such as eLogbooks into your processes.

So, is an eLogbook just your usual paper-based logbook in a digital form? You might be thinking. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/heres-why-you-should-switch-to-elogbooks-today/

Digitizing Shop Floor Operations for Pharma Manufacturing Excellence - Pharmision Barcode India

 

A survey of US-based manufacturers carried out by PwC and The Manufacturing Institute found that 73% are planning to increase their investment in smart factory technology over the next year.

The study also points towards a definitive and inevitable shift to Industry 4.0 as Pharma companies seek to integrate new technologies into their supply chains and manufacturing operations.

Digitizing shop floor operations helps Pharma manufacturers keep track of, schedule, and accurately record events in their manufacturing facilities.

Traditionally, shop-floor managers had to manually monitor activities on the factory floor in the majority of manufacturing settings. These manual techniques typically involve monitoring production batches using paper-based systems used intermittently throughout the day.

Not only was this manual approach time-consuming but it also did not give decision-makers the data-supported insights they need to manage the production process. As a result, managers were forced to deal with issues in a ‘reactive’ rather than ‘proactive’ manner.

With the advent of cutting-edge technology, digital shop floor control systems allow manufacturers to give factory floor workers real-time visibility into the production line and other important activities, enabling managers to better control their manufacturing processes, spot issues quickly, and use the power of analytics for pre-emptive measures. Read more.....

Source Link:-  https://www.pharmision.barcodeindia.com/blogs/digitizing-shop-floor-operations-for-pharma-manufacturing-excellence/

3 Ways to Increase Productivity and Quality in Pharmaceutical Manufacturing - Pharmision Barcode India

 

Did you know that according to the 2019 PhRMA member annual survey, members of the Pharmaceutical Research and Manufacturers of America (PhRMA) trade association spent a record-breaking $79.6 billion on research and development in 2018?

Pharma manufacturers the world over are focusing on innovation to increase productivity and product quality due to growing competition, shifting regulatory requirements, disruptive technology, and several other considerations.

So, how can manufacturers improve quality and productivity?

Here are three practical steps to take:

1. Automating Manufacturing processes

The pharmaceutical sector has some of the strictest quality standards in the world. Everything in the process, from creating the items to labeling the packaging to sanitizing the tools used, needs to be carefully under control. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/3-ways-to-increase-productivity-and-quality-in-pharmaceutical-manufacturing/

How Can Pharma Companies Avoid Data Integrity Issues? - Pharmision Barcode India

Did you know that 65% of warning letters issued by the FDA cited data integrity problems in 2021? That is a massive spike from 2020, where 51% of the 483s cited data integrity as a problem. Data integrity is a critical topic in pharma manufacturing. Despite the FDA’s ‘set-in-stone’ guidelines, we see numerous 483s citing data integrity as an issue each year. And this problem exists globally.

What is data integrity?

Data integrity is the practice of maintaining and ensuring the accuracy of data consistently during the manufacturing of a product. All records during the manufacturing process need to be validated as per FDA’s guidelines. Any change to the data without reflecting in the records is considered a failure of data integrity.

It involves ensuring which user created and saved a record along with date and timestamps and that all data is accurate, consistent, and complete, making it reliable and trustworthy.

It is important to note that FDA has not made any changes to the definitions or regulations or expectations in recent years. There have not been any new guidelines or regulations in the category. This clearly indicates that the companies have not been able to implement the requirements satisfactorily.

To ensure data integrity, pharma manufacturers need to ensure all data meets the guidelines outlined in the ALCOA acronym:

1. Attributable – All information about the person collecting the data, the origin of the data, and the timestamp of data collection.
2. Legible – Data should be easy to read.
3. Contemporaneous – All data must be recorded as and when the activity is done.
4. Original – The original data records need to be preserved throughout their life cycle and be long-lasting.
5. Accurate – Data needs to be error-free and high quality, with all changes being reflected in the supporting documentation.

For more information, visit https://www.pharmision.barcodeindia.com/blogs/how-can-pharma-companies-avoid-data-integrity-issues/

Pharma Digital Transformation – The Key to a Better Future - BCI Pharmision

The pharmaceutical industry is undergoing a wave of digital transformation. Powered by technologies such as advanced mobile communications, the cloud, advanced analytics, and the Internet of Things, the sector has been able to achieve dramatic results in terms of product quality, costs incurred in production, and time required for manufacturing. Today, pharma executives are well aware of the disruptive potential of embracing and utilizing technology and are experimenting with a wide range of digital initiatives.

However, there are companies that are yet to understand the importance of digital transformation.

A McKinsey study on Digital Quotients (DQ) across sectors on a 100-point scale found that
pharma’s score of 27 lags behind the average of 33 across sectors. It even trails other highly regulated businesses, such as banking (32) and insurance (31). In fact, pharma scores were closer to those of sectors that historically have been digital laggards, including the public and social sectors.

For more information, visit https://www.pharmision.barcodeindia.com/blogs/pharma-digital-transformation-the-key-to-a-better-future/

5 Incredible Benefits of 21 CFR Part 11 Compliant Software - BCI Pharmision

If you maintain records or submit information to the Food and Drug Administration (FDA) electronically, you need to comply with 21 CFR Part 11.

If you are not aware of FDA’s regulation, this article will tell you all you need to know about it, why it’s important for you and the best way to implement it in your organization.

We’ll also tell you briefly about how our 21 CFR Part 11 compliant solution stack makes it super easy for you to not only adhere to the FDA regulations but also benefit greatly from it.

What is 21 CFR Part 11?

In August 1997, FDA issued a set of regulations that enlist its acceptance criteria for all forms of electronic data.

This set of regulations was issued as Part 11 of Title 21 of FDA’s Code of Federal Regulations, simply known as 21 CFR Part 11. It applies to all electronic records that are created, modified, maintained, archived, retrieved, or transmitted. It also gives us guidelines for setting up an FDA compliant, digital Quality Management System, where digital records and signatures are used in place of traditional methods.

The recommendations under 21 CFR Part 11 are in line with Pharmaceutical Good Manufacturing Practice (GMP).

For more information, visit https://www.pharmision.barcodeindia.com/blogs/5-incredible-benefits-of-21-cfr-part-11-compliant-software/