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/

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/