5 Benefits of digitizing Pharma Batch Manufacturing Records (BMRs)
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The pharmaceutical industry’s global share will multiply and reach USD 1,494 billion by the end of 2023. America and Europe are two regions that hold the largest share of 38% and 30%, respectively.
Moreover, the pharmaceutical industry involves several documents related to operations on each production level; thus, considering the growing market share and increasing everyday operations, it becomes necessary to manage them efficiently.
Batch Manufacturing records are one of the many document-related operations that these companies deal with daily.
But what are they? And why is it so necessary for pharma companies to invest in a solution that helps them digitize these records?
Let’s see.
What are batch manufacturing records?
Crucial to track the complete cycle of each manufactured batch; a BMR is an essential quality and GMP document.
In layman’s terms, it is an approved MFR for each manufactured batch. It is a written record containing details regarding the batches the company has produced.
To put it more in context, a BMR will have all the information regarding all phases of the manufacturing process, right from the assignment of raw materials to packaging.
Following are some details that a batch manufacturing record consists of:
- Information regarding the production location
- Detail regarding unique batch numbers
- Quality tests reports
- Majorly used equipment
- Information regarding sampling processes
- Specific details of batches like weight, measurements, etc.
Why is it important to digitize Batch Manufacturing Records?
Storage requirements
For every slot of drug a pharma company produces, it is mandated to create a Batch Manufacturing Record. This document consists of important information that one might need to recall the entire batch after it gets dispatched in case it is required.
This means that if a company produces 100 different batches of the drug daily, it will have to get the paperwork done before it goes out in the market.
Implying they will have 100 additional files to take care of at the end of each day.
Which is just one aspect of it.
These records have to be retained by the manufacturing company till:
- Either one year after the product’s expiry,
- Or 5 years after authorities approve such a batch.
In both cases, these documents’ retention period lies between 3-6 years.
Considering the number of these files and the retention period, finding a place where they can be stored and maintained properly regularly becomes more challenging.
Even the storage facilities that promise you security and frictionless processes might bail on you.
Disorganization
Organization is the key whether you go for a storage facility or a cloud-based solution. If you can not retrieve the stored documents within time, then there is no point in investing in such alternatives.
The point is to find a solution that helps you organize these stacks of files and paper easily so you can retrieve them and comply with the FDA and CDSCO regulations as required.
Failing which, you might have to pay hefty penalties and fines, which can directly impact your overall business’s profitability and goodwill.
Storage costs
Say you find a storage facility ready to offer you its services. They are absolutely okay with managing the regularly increasing paper piles and agree with these documents’ retention periods.
But do you think they are going to be inexpensive?
Obviously, they are going to charge you very high. And the number they quote might not even justify the benefits that you get out of it. Because apart from storage, what other problem of yours are they addressing?
Retrieval issues? It will take anywhere from 5-7 days or even more to retrieve a document once it’s handed over.
Security concerns? No facility ever takes liability for any damages caused to your property while with them. Fire, theft, water damage, whatever it may be, it’s on you.
Delays in updation
A regular addition to paperwork means you will need these documents to reach the storage daily. You can’t keep those many files where you work because it is only a few days before 100 becomes 200, and you know how it goes.
Therefore, you will need to update these regularly, and it can become an additional unproductive step in the entire process.
5 benefits of digitizing Batch Manufacturing Records:
Eliminates risks of human error
Creating these records manually for each batch that goes out can increase the risks of human error. Automating the workflow can help you eliminate that and stay accurate throughout the process without jeopardizing your business’s operations at any cost.
It also eliminates any chances of human error that might occur during the process of organizing your documents. Since most advanced document management systems are equipped with the features like category-specific tags and common repositories, it makes the entire process seamless without any potential errors that might cause a problem in the long run.
Increases productivity
All that time you invested earlier in the filling, tagging, labelling, and finally dispatching each document is saved as soon as you switch to a document management system that helps you digitize and automate the same.
Meaning thereby your workforce is no longer occupied by unproductive tasks in the name of compliance. They can use their free time to perform more important tasks, and thus your company’s productivity will scale with time.
Keep up with compliances
The major reason why digitizing batch manufacturing records is essential for pharma companies is to keep up with regulatory compliances. These records must be maintained for internal and external audit purposes; thus, storing them securely and organizing them so that retrieving them instantly becomes possible is important.
Reduced overheads
Apart from the obvious costs associated with managing paper-based records, there are other expenses. One of the major expenses that companies bear is storage costs. Whether you choose to go with a storage facility or stack them in the corner of a rented place, real estate is expensive, and it will burn a hole in your pocket either way.
Real-time monitoring capabilities
Once you opt for a storage facility or stack your records in the corner of your office, they are out of sight. You don’t have any clue of what is happening with them if they are securely stored or not.
They might get into the hands of people who are not authorized to access them or get stolen. Moreover, when these documents are being worked upon, it becomes difficult to track their status and who is currently in ownership of these papers.
All these concerns just vaporize in thin air the moment you digitize them. Smart document management systems like dox2U allow you to track these documents and keep a tab on the activities without missing details. Thus, transparency!
Having a document management system that helps you digitize your paper-based operations is essential to scale your organization’s overall productivity, bring back the employee’s lost efficiency, eliminate human errors and keep up with regulatory complaints.
It would help if you digitize entirely and go paperless. There are many reasons, but to put it in perspective in a few words, it would be better to say that paper brings nothing but worries.
Digitize with dox2U today– a cloud-based document management system that also offers free Trial.
