Ensuring Data Integrity in Pharma Companies: Practical Steps to Take Today - Pharmision Barcode India

 

The pharmaceutical industry faces mounting pressure to meet stringent compliance standards by global drug regulators. As a result, the FDA emphasizes the critical role of data integrity in Good Manufacturing Practices. Despite this emphasis, FDA warning letters continue to cite data integrity as a failure, with recent years witnessing an increase in citations after a temporary decrease in 2017-2019.

Although the recent 483s citing data integrity have yet to reach nearly 80%, as witnessed in FY2016, it continues to be a problem that the FDA-governed industry struggles with. Moreover, the deficiencies continue to be the same as they were a decade ago

How can pharma companies ensure data integrity?

To maintain data integrity throughout processes and ensure consistency, organizations can implement fundamental changes that are easy to implement and provide long-lasting benefits. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/ensuring-data-integrity-in-pharma-companies-practical-steps-to-take-today/

Why Must Pharmaceutical Companies Switch to eLog Management Solutions? - Pharmision Barcode India

 

According to FDA’s 21 CFR Part 11, recording and maintaining equipment usage, cleaning, and other GMP activities with the necessary audit trails is essential. Yet, despite its significance, log documentation today is still primarily a time-consuming, paper-based process that puts life sciences manufacturers at serious compliance risk.

Data entry by hand in paper logbooks is labor-intensive and prone to error. First, employees spend hundreds of hours creating, reviewing, and approving logs. Then, during audits and inspections, they waste more time locating this information, which is often stored in various physical locations.

Drawbacks of paper-based log management

The pharma industry has historically needed to be faster to adopt new technology. As a result, many companies continue to follow paper-based log management. However, here are some challenges with this manual and paper-based approach:

Reduced productivity: Manually recording log activities uses many resources. Equipment usage logs take time to physically (and methodically) record the date, time, product, and lot number of each batch. It takes just as long to register the necessary cleaning data. As a result, productivity is severely impacted by manual log management. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/why-must-pharmaceutical-companies-switch-to-elog-management-solutions/

Automation & Digital Transformation – In the Pursuit of Excellence - Pharmision Barcode India

 

As guardians of human health and life, research and innovation are the non-negotiables for pharma professionals. More than anything else, pharmaceutical companies who tirelessly keep transitioning from one process to another have realized that they need to elevate collaboration between people, equipment, and tech.

Organizations have realized the importance of knowing when they can and they need to produce various drugs, the need for timely delivery, and the urgency of being present whenever there are patient needs. This is accomplished by maintaining a strong network of distribution to establish their brand value and equity.

What automation will mean then

Old school processes require extensive manual intervention from workers and employees. Automation helps eliminate this need and increase quality levels of the output for continuous manufacturing – that is fast spreading across key players for its ability to produce medicines in an end-to-end manner in a single production line. In other words, automation will help reinvent and reimagine how organizations can manufacture medicines with optimized capabilities and how much they can scale while being in line with all regulatory compliances from start to finish! Read more....

Source link:- https://www.pharmision.barcodeindia.com/blogs/automation-digital-transformation-in-the-pursuit-of-excellence/

How Pharma 4.0 will revolutionize the Pharmaceutical Industry - Pharmision Barcode India

 

The pharmaceutical industry has been undergoing a massive overhaul. There’s a paradigm shift that is going on, to further improve productivity and quality. And the Pharma 4.0 initiative is the benchmark that the industry is trying to gradually upgrade to.

Through digitalization and the use of smarter tools and processes, Pharma 4.0 is expected to not only improve productivity but also ensure better quality and save time and costs, among several other benefits.

ISPE (International Society for Pharmacoepidemiology) is in the process of developing the roadmap to introduce Industry 4.0 to the pharmaceutical industry as Pharma 4.0.

What is Pharma 4.0?

Developed in 2017, Pharma 4.0 is an ISPE initiative that aims to improve the processes throughout the life cycle of pharmaceutical products with the help of modern smart technology.

It aims to do so by aligning the pharmaceutical industry with the philosophy of Industry 4.0. Read more.....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/how-pharma-4-0-will-revolutionize-the-pharmaceutical-industry/

Top 3 Challenges in Pharma Manufacturing Today - Pharmision Barcode India

 

Stricter regulatory requirements, the need for better quality control, supply chain disruptions, and cost pressures have had significant impacts on pharma manufacturing in recent years.

Pharma manufacturers today must carefully reevaluate their long-term decisions in sourcing, manufacturing, and supply chain in light of factors like the COVID-19 pandemic, strict FDA regulations and supply chain disruptions owing to geopolitics and other causes.

This article explores the top 3 challenges facing pharma leaders today and the steps they can take to develop a more strategic, long-term, and integrated approach to tackle these issues.

Need for better quality control

In the pharmaceutical industry, quality control is of utmost significance. There are numerous reasons why quality control is the cornerstone of this industry, including the need to adhere to stringent local, national, and international regulations as well as quality standards for goods produced for human consumption.

The manufacturing environment must also adhere to very strict standards. To oversee the plant and production for all of these activities, qualified personnel must be well-trained. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/top-3-challenges-in-pharma-manufacturing-today/

7 Benefits of Warehouse Automation in the Pharma Industry - Pharmision Barcode India

 

With the introduction of the Pharma 4.0 guidelines, the pharmaceutical industry has been undergoing a sea change when it comes to embracing new technology. The industry understands how process automation can completely change the way businesses are run and how it enables them to optimize processes, improve data collection and storage, deliver higher quality than ever at significantly lower costs, and at a considerably reduced time-to-market.

Process automation has also transformed warehousing in the pharmaceutical industry. A vital part of the supply chain lifecycle, warehousing in the pharma industry is especially crucial given the strict regulatory quality and safety compliances demanded from the industry. It’s no wonder that pharma warehouses across the globe are becoming smarter with each passing day. Automated Warehouses are often equipped with Warehouse Management Systems to optimize daily processes.

Warehouse Management Systems (WMS)

Warehouse Management Systems are a set of tools and software that automate warehouse operations. They enable warehouse managers to have better control by automating daily processes such as storing, labeling, and tracking inventory, managing workers and their operations, analyzing captured data, and carrying out routine checks. WMS is seamlessly integrated into warehouse operations with no downtime required for installation, making them easy to adopt for any organization looking to opt for it. For the pharmaceutical industry, all WMS must be GMP and 21 CFR part 11 compliant solutions and meet all ALCOA+ requirements. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/7-benefits-of-warehouse-automation-in-the-pharma-industry/

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/

Robust WMS re-shaping the future of Pharmaceutical Supply Chain - BCI Pharmision

 

Why The Pharma Industry Needs a Robust WMS

The global pharmaceutical industry has grown phenomenally over the past decade. This is reasonably so, given the advancement in research and innovation. However, since 2019 there has been a significant impact on this industry due to Covid-19, both on the demand and supply side. Manpower availability and logistics continuity were deeply affected exposing the need for local and regional self-reliance for manufacturing and warehousing. The result of which has been that The World Economic Outlook reported a global growth at 4.4%, considerably lesser by 7% as witnessed in 2019.

However, the Indian numbers for the pharma industry have been buoyant, to say the least. According to FICCI and EY’s Indian Pharmaceutical Industry 2021 report, India is on track to achieve $130BN target sales by 2030, at a CAGR of 12% from 2020-2030. This is much higher than global number predictions. And while India is gunning to become a global supplier of drugs, it is looking to get there by focusing on four key enablers.

Research & Innovation – By not just producing licensed drugs in India, but also actively pursuing research in the field of drugs and testing.

Healthcare access – Actuating deep penetration of healthcare across the country.

Access to medicines – Studying and building globally competitive drug pricing and procurement models so that access to drugs is not blocked.

Strengthening manufacturing and supply base – Decentralizing drug manufacturing and realizing the importance of efficient supply chain and logistics infrastructure.

Manufacturing Encouragement from the Government

India supplies over 60% of global demand for vaccines and over 40% of generic pharma demand in the US. No wonder it’s called the pharmacy of the world. India currently has more than 10,500 manufacturing units across the country, catering to more than 150 countries. To bolster these solid numbers further, the government is encouraging private manufacturers with new schemes and subsidies. The idea is to instill pride of quality in ‘Make in India’.

The offshoot of this nudge is that there will be satellite manufacturing units that will mushroom all over the country. This will, in no way, hamper the manufacturing quality, as stringent testing and manufacturing SOPS will ensure meeting global standards, but where breakage of quality might occur is warehousing and logistics. We know that all through the Supply chain, there is constant and consistent checking and tests. This makes it more crucial to have a seamless and world-class Warehouse Management Software (WMS).

WMS And Its Importance

Supply chains across industries cannot exist without robust warehousing, and this is of utmost significance in the pharma sector. Given its regulations adherence, drugs warehousing must be transparent, error-free, and seamless. Here are some of the other vital strong points of a good Warehouse Management Software.

Inventory Management – Perhaps no other manufacturing industry is as strict and a stickler for manufacturing and expiry date protocol as the pharma industry. And not without reason because its efficacy and people’s lives depend on it. An excellent WMS can track products in the warehouse as per expiry dates and help optimize first-expired-first-out meds.

Temperature Maintenance – Quite often pharmaceuticals must be maintained at constant temperatures. Without a doubt, this must be integrated with a WMS rather than manual operations. Automating climate-controlling can reduce contamination, promptly identify, and inform refrigerator/freezer breakage, and at the same time, optimize energy usage.

Security Concerns – Yes, a good WMS gives you a clear stock of all the inventory at any time in your warehouse. It also details stock coming in and batches going out. However, where it similarly excels is in labeling and vendor tracking. This is of importance when managing spillage and possible theft too. For more information, visit https://www.pharmision.barcodeindia.com/blogs/robust-wms-re-shaping-the-future-of-pharmaceutical-supply-chain/

Digital Transformation in Pharma Manufacturing and its Benefits - BCI Pharmision

 

According to a KPMG study, companies in the life sciences industry have already recognized that digital transformation will lead to changing roles in the ecosystem. 85% of respondents see tech companies as the driving force of digitalization in their industry, and 63% see these companies as possible cooperation partners within the next year.

More than digitization’s far-reaching benefits, it has become a necessity in the pharma industry. The Food and Drug Administration (FDA) has made that quite clear through its guidelines. Companies need to eliminate the scope of human error in an industry where tolerances in precision and quality are nil. They must set up and adopt processes and SOPs to guarantee high-quality products.

Another reason why digitization is key to the life sciences industry is a certain emerging trend.

The new buzzword in the pharma industry is patient-centricity.

Many industry experts have the opinion that patient-centricity will be of prime importance in the coming years and digitalization is instrumental in this important step. In the same KPMG study, 17 percent of respondents named ‘patient-centricity’ as a current benefit of digitalization, while 24 percent believed this will be a key focus within the next 5 years.

But is digital transformation an absolute necessity? Let us find out…

The Problem with the Traditional Way of Functioning
One of the biggest challenges that pharma manufacturers with traditional setups often face are issues bridging the gaps between people and systems, people, and data, and even between groups of people. This affects manufacturing processes, performance, and even product quality.

These companies’ manual processes are slow, cumbersome, and prone to human error. This negatively impacts their ability to meet the good manufacturing practice (cGMP) guidelines. The most common issues faced by these organizations include, but are not limited to Inefficient processes, Illegible and inaccurate information, data integrity, disconnected systems, and human error. For more information, visit https://www.pharmision.barcodeindia.com/blogs/digital-transformation-in-pharma-manufacturing-and-its-benefits/

Why Pharma Companies Need to Automate Manufacturing Processes Today - BCI Pharmision

 

The tragic news of 66 Gambian children dying after consuming Indian cough syrups has sent shockwaves through the world.

The WHO has said that it has found ‘unacceptable amounts’ of diethylene glycol in the syrups, which when consumed can cause life-threatening gastrointestinal symptoms.

Despite the Food and Drug Administration (FDA) stressing on adherence to regulatory compliances, there are several companies in the world today that are failing to do so. There is no tolerance for error in the pharmaceutical industry and the unfortunate tragedy that occurred is a stark example of the repercussions of non-compliance.

Speaking of non-compliance, a few alarming trends emerge when we go over the warning letter issued by the Food and Drug Administration (FDA) between FY2013 and FY2018 (refer Table 1 below).

The number of warning letters issued keep going up each year and a majority of the 483s cite data integrity as an issue. In FY2018, for example, data integrity deficiencies were cited in 57 percent of all warning letters (excluding those issued to compounding pharmacies).

Yes, the FDA has become stricter with their inspections each year, but warning letters issued over the years indicate that many pharmaceutical companies continue to struggle to meet the compliance criteria for a few basic, yet critical rules.

These observations raise a bunch of questions…

Why are so many pharmaceutical companies failing to meet certain compliance criteria time and time again?

What is the root cause behind some problems persisting over the years, such as lack of data integrity?

Is it a competence issue with staff or does the fault lie with the SOPs?

And what are the companies complying with the regulations doing differently?

Table 1: Breakdown of FDA 483s for the period FY2013 to FY2018

Source: An Analysis of FDA FY2018 Drug GMP Warning Letters (pharmaceuticalonline.com)

Over the years, the Food and Drug Administration (FDA) has cited the failure to implement a reliable process monitoring program to ensure better control over the manufacturing process as a problem area pharma companies should work on.

The obvious information that we can glean from this is that pharma companies need to embrace automation and digitization in order to meet the compliance criteria. With the industry known for its stringent guidelines, this should have seemed obvious. But, according to a global McKinsey study, the pharma industry ranks quite low in terms of digital maturity and has been slow to adapt to new technology. For more information, visit https://www.pharmision.barcodeindia.com/blogs/why-pharma-companies-need-to-automate-manufacturing-processes-today/

7 Benefits of Warehouse Automation in the Pharma Industry - BCI Pharmision

 

With the introduction of the Pharma 4.0 guidelines, the pharmaceutical industry has been undergoing a sea change when it comes to embracing new technology. The industry understands how process automation can completely change the way businesses are run and how it enables them to optimize processes, improve data collection and storage, deliver higher quality than ever at significantly lower costs, and at a considerably reduced time-to-market.

Process automation has also transformed warehousing in the pharmaceutical industry. A vital part of the supply chain lifecycle, warehousing in the pharma industry is especially crucial given the strict regulatory quality and safety compliances demanded from the industry. It’s no wonder that pharma warehouses across the globe are becoming smarter with each passing day. Automated Warehouses are often equipped with Warehouse Management Systems to optimize daily processes.

Warehouse Management Systems (WMS)

Warehouse Management Systems are a set of tools and software that automate warehouse operations. They enable warehouse managers to have better control by automating daily processes such as storing, labeling, and tracking inventory, managing workers and their operations, analyzing captured data, and carrying out routine checks. WMS is seamlessly integrated into warehouse operations with no downtime required for installation, making them easy to adopt for any organization looking to opt for it. For the pharmaceutical industry, all WMS must be GMP and 21 CFR part 11 compliant solutions and meet all ALCOA+ requirements.

Benefits of warehouse automation

There are several benefits to automating warehouse operations. While some benefits, such as an increase in efficiency and a safer work environment, are immediately obvious, other benefits take a while to be noticed. For the sake of brevity of this article we have mentioned only seven benefits:

Improved Operational Efficiencyc

One of the biggest reasons why most pharma companies opt for warehouse automation is to improve their efficiency. It allows them to increase capacity and refine their processes thanks to the level of optimization possible with the latest technology in warehouse automation. Improved operational efficiency has a direct correlation with KPIs such as time, cost, quality, and productivity, which means it also has a huge positive impact on the business.

Minimized Errors

Automating warehouse processes reduces the chance of human error, which can be extremely dangerous in the case of a sensitive industry such as pharma, where stringent standards and complex regulations are to be met. Automating manual processes such as data collection, handling, and analyzing ensures that the information recorded is reliable and error-free. This can assist the pharmaceutical industry to meet stringent standards and complex regulations. Minimizing errors in a warehouse also benefits a company by reducing wastage and loss.

Optimized cost

While warehouse automation requires a company to invest first, the ROI on it is surprisingly quick. This is due to the fact that automation saves a lot of time and considerable cost through increased efficiency, optimized storage space, improved quality, higher productivity, and substantially minimized error, wastage, and loss. This is another reason why the pharma industry has witnessed a rise in the number of companies opting for warehouse automation solutions. Not only does deploying warehouse automation bring a competitive edge to a company but it also helps make greater margins of profit in the long run.

Better Quality Control and Assurance

Quality Control and Quality Assurance are of prime importance in the pharma industry, with numerous tests being carried out throughout the lifecycle of the product even while at the warehouse. The industry has greatly benefitted by automating all warehouse processes related to QA/AC, from sampling to labeling, to calibration and validation of the products. Warehouse automation is also convenient when it comes to the frequent quality audits that are typical to the pharma industry.

Improved Data Analytics and Integrity

Automating data collection and analysis has a number of benefits. First, a large amount of data can be collated, processed, and analyzed with precision, meaning that a large amount of data is gathered and processed accurately in a relatively short amount of time. Data Integrity is extremely critical in the pharma industry, owing to the strict standards and regulations that are to be met. It also helps during audits, when the people in charge are confident that the data is authentic and error-free.

Sustainability

An added advantage of adopting warehouse management solutions is that it enables business owners to achieve their environment-related goals. Automated warehouses optimize resource usage and space, reduce losses, and also enable considerable energy savings, which make it an excellent choice for businesses looking to attain their sustainability goals. The best part about automating warehouses is that sustainability comes as a natural by-product owing to the optimized performance that the use of technology enables. For more information, visit https://www.pharmision.barcodeindia.com/blogs/7-benefits-of-warehouse-automation-in-the-pharma-industry/

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/