In the current scenario, with the COVID-19 pandemic still being an imminent threat, all the major and minor industrial sectors are undergoing massive changes. Same goes for the pharmaceutical manufacturing industry, which is facing more business challenges than ever before.
The pharma companies worldwide were already finding it hard to keep pace with the changing regulatory, traceability, & quality control requirements, radical healthcare reforms, increasing process complexities, changing consumer reforms, volatile market trends, tight competition, and more.
To add to it, the disruptions brought by Industry 4.0 and digitization in the pharmaceutical manufacturing sector have had far-reaching consequences for the industry. Together, these challenges have underpinned pharma manufacturers to the wall and forced them to go back to the drawing board.
The need to differentiate themselves
Given the conditions at hand, pharmaceutical manufacturing businesses need to differentiate themselves in order to stand out. They need to improve their current operational practices, streamline their processes, maximize operational efficiency to reduce costs, and win consumer loyalty.
On top of it, they need to produce healthcare products at compelling prices, while upholding the quality standards, and meeting the precise regulatory compliance across all manufacturing processes, along with faster turnaround times.
To achieve this, pharma manufacturers need to have a system in place that offers streamlined workflow, data-backed analytics, and centralized management, and facilitates agile decision-making. A system, that helps reduce cost, and improve the manufacturing processes, patient safety, hygiene standards etc., too.
ERP software to the rescue
In these demanding times, the manufacturers need to put in place a robust IT infrastructure that among other things, also allows leveraging the data that’s available in abundance. In short, they need to equip themselves with the best-in-class ERP software to stay ahead of the curve.
An ERP software for pharmaceutical industry emerges as the system that controls, connects, and integrates all the departments, and internal processes, and automates all the key functions such as planning, procurement, inventory, manufacturing, and business intelligence.
Moreover, it also helps manufacturers keep a track on sensitive operations across organization, such as compliance, expiries, quality, formulation, costing, yield and more. This enhances transparency in operations, and facilitates smooth functioning of the entire pharma manufacturing unit.
To better understand the different roles an ERP software plays for pharmaceutical manufacturing businesses through its different modules, continue reading:
Formulation holds great significance in pharmaceutical manufacturing industry, and a pharmaceutical ERP software plays a crucial role in managing it. Created after an intense research, a formula is protected by copyrights, and should be accurately followed, without allowing any margin of error.
An ERP system for pharmaceutical manufacturing helps manufacturers manage all the essential aspects of formulation, including storing, retrieving, and revising every formula used in the business, and maintaining countless manufacturing instructions, besides offering different essential functionalities.
Allows global integration
Majority of pharmaceutical products are manufactured by different pharma companies across the globe. This calls for the mandatory provisions for global integration. A good pharmaceutical manufacturing software must offer integration options, that too in real-time.
For instance, it should be able to handle conversions associated with the challenges posed by differential time zones, currencies, language, etc. which could actually be taxing and time-consuming if converted and translated manually.
Helps meet regulatory compliance
The pharma manufacturers must always keep abreast of the latest industry, and compliance standards as well as policies. A pharmaceutical ERP software helps in this regard, as it comes with a dedicated module to manage comprehensive compliance amid dynamic changes in the regulatory landscape.
With its features such as workflows, approval controls, and audit trails, an ERP for pharmaceuticals ensures that the pharma companies adhere to all the local & global regulatory compliances such as the FDA CFR 21 Part 11, and also other requirements, and perform vigilant audits.
Helps with Quality Control & traceability
Manufacturing pharma products that meet highest quality standards, and are completely safe and fit for consumption, is one of the top priorities for pharma manufacturers. To ensure this, they need the ability to quickly identify where, when, and what goes wrong at their manufacturing plant, and fix it.
A pharma ERP solution with strong Quality Control (QC) & traceability functionalities ensures full conformance with expected results by allowing only the appropriate materials to be sent for approvals, while rejecting & sending the inappropriate ones for quarantine. Also, by allowing tracing & tracking the ingredients, it enables swift product recalls through its bi-directional traceability functionality.
Helps with inventory,& supplier management
A good pharmaceutical ERP software allows manufacturers to make sure that inventory is always sufficient and enough to meet demand and forecasts. Besides, it offers a way to monitor and control pilferage in real-time, and to create triggers for needed replenishment and procurement, materials usage, and inventory status changes.
Additionally, an ERP software for pharmaceutical industry allows the manufacturers to procure raw materials from only the recognized suppliers who have the ‘Supplier Verification’. This way, only the high quality, and safe materials enter the system, as the software accepts raw materials procured only from the authorized vendors whose information is stored in the system.
Provides support to sample management, clinical trials, and commercialization
Extensive clinical trials, and rigorous sample testing are an inseparable part of the pharma manufacturing process. Keeping a manual record of these samples could lead to costly errors. Hence, pharma companies rely on ERP for pharmaceuticals that allow maintaining such records and trial histories in a centralized database that can be accessed anytime for reference use and audit purpose.
An ERP for pharmaceutical industry also helps the manufacturers manage the complex, multi-layered processes involved in developing a product, getting it approved, and even launching it. Basically, it provides support to commercialization, i.e., to all the processes such as manufacturing, sales and marketing, production planning, distribution, and quality management, etc.
Allows production as per cGMP norms
Manufacturing operations in a pharma company must be conducted as per the cGMP norms, and a pharma ERP software ensures it. It allows the manufacturers to maintain the pre-production records in the MBR, so as to check if the production is done as per the set industry standards.
Post production, the entire production process data is stored in the Batch Master Record (BMR), which can be compared to the MBR for audit purpose and also to see if there is any deviation,which, if found, can be fixed through NC/CAPA.
It ensures data security
Data security is of paramount importance for pharmaceutical manufacturing businesses that spend a significant number of resources on research and development initiatives; be it related to formulation, material substitution, sensitive reports,or even the customer order details.
A pharmaceutical manufacturing ERP software offers a wide range of stringent security protocols such as access controls, data encryption, audit trails, and electronic signatures and passwords, among others, to ensure that the fatal security breaches remain at a bay.
To sum up
By reading this blog, you might have got a fair bit of insight into the role of an ERP software for pharma industry. If you are looking to re-engineer the processes of your pharma company in order to stay afloat in the wake of existing challenges, a pharma ERP solutions just what you need.
We at BatchMaster have a comprehensive experience of serving the pharma manufacturers with distinction for past 30+ years through our ERP solution tailored specifically for the pharma manufacturing industry. Reach out to our team of experts for a free demo/consultation.