In the current ‘ultra-competitive’ business scenario, every business needs a contemporary ERP solution irrespective of its size. Still many businesses are oblivious of this fact, and either use outdated IT systems to run their business operations, or don’t use an ERP at all. Talking about manufacturing small & medium enterprises (SMEs), many feel that their business doesn’t need an ERP. But things are changing, and many manufacturing SMEs are finally shedding a lot of their misconceptions. They are coming to terms with the fact that they aren’t ‘too small’ for an ERP solution; that it’s not the number of users that determines the need for an ERP solution; and that ERP tools are not best-suited only for large-scale industries due to high cost of ownership, complexity of implementation and subsequent maintenance costs.
In fact, the challenges manufacturing SMEs face, and the needs they have, aren’t any different than that of large manufacturing industries. This includes the need to follow the regulatory mandates, meet reporting requirements, as well as quality parameters, manage resources, keep a check on costs, etc. To fulfill these requirements, the manufacturing SMEs need a tool that can help them standardize their processes, streamline their operations, keep a tight lid on the costs as well as wastage, stay audit-ready, and make best use of the resources, among other things.
Additionally, they need a tool that can help them become faster and sharper than the competition, and taking their specifics into account, help them realize the full potential of their market. And an ERP software is precisely that tool. The manufacturing SMEs too are fast getting aware of the benefits of this long-term investment.
This includes pharmaceutical manufacturing SMEs too
Yes, the pharmaceutical manufacturing SMEs too are warming up to the idea of having a pharma ERP to run their business operations. Earlier, they would focus only on investing in resources that directly impact the productivity, and pay little attention to investing in a pharmaceutical software that can also impact the business in more ways than one. As a result, such businesses were happy using spreadsheets and manual, paper-based processes. But today, a majority of these businesses have realized that forget about thriving; following such practices won’t even help them sustain in the long run. To get to the next stage of growth, a pharma ERP software is going to be of paramount importance, and the absence of which can mean the difference between survival and dissolution.
Time and again, a pharma ERP has proven that the benefits it offers to a pharmaceutical manufacturing SME are too good to be ignored. It brings in more efficiency through streamlined operations, and more transparency; improves the responsiveness to the customers and in turn, the customer satisfaction; facilitates accurate, data-backed, and quick decision making; boost productivity; streamlines the data flow within the organization; helps reduce the operating costs; offers next-level automation; and helps stay compliant to regulatory mandates, as well as meet all the quality parameters.
A pharma ERP delivers the benefits mentioned above through its powerful set of features. Though there are many essential features, but if we’ve to talk strictly about the five ‘superpower’ features of a pharma ERP software, what could those be?
These five powerful features make pharma ERP a ‘must-have’ for manufacturing SMEs
Formulation/Recipe management – Formulation management holds great significance in the pharma industry. A formula/recipe is the pharma manufacturer’s most valuable business asset. As a matter of fact, a pharma manufacturer’s success hinges on formulation’s successful management, which includes formula control, security, and tracking. A good pharma ERP software allows the manufacturing SMEs to document all the details associated with each ingredient and how it’s used in the manufacturing process. It also allows them to track ingredient details, store formulations, and secure each formula with an approval workflow. This feature also ensures selective access, which means only a selected few have access to the formula and its use.
Batch Processing: Manufacturing in a pharma business is done in batches that too as per cGMP guidelines. An ERP solution that understands and follows this is what manufacturers should look for. The key is to check if the ERP can very well differentiate and handle the production of tablets/powders, capsules/soft gelatins, syrups etc. It must be able to seamlessly handle the entire production process from batch creation to ticketing and finally closure along with calculating the production cost considering the material, labor, and other costs. What’s specific to a Pharma ERP is its readiness to print BMR and MBR, perform batch monitoring activities, dynamically size batches as per specifications, execute SOPs and such.
Quality & Regulatory compliance – A good pharma ERP software allows pharma manufacturing SMEs to ensure compliance with regulatory requirements such as FDA 21 CFR, and other industry, environmental, as well as regulatory requirements. It has numerous features in place such as workflows, approval controls, and audit trails that help make compliance easier for the pharma manufacturers. Also, a pharmaceutical software integrates formulation management with regulatory requirements to create a productive business model that meets all industry norms and government regulations.
Safety is of paramount importance in the pharmaceutical manufacturing industry. Any drug that reaches the end consumer should be absolutely safe and fit for consumption. Hence, any good pharmaceutical software for pharma manufacturing SMEs must include quality assurance (QA) & quality control (QC) capabilities including stability testing. It should support QA testing, document the entire process and the outcome of each test, eliminate even the slightest of slip-ups, and ensure conformance with expected results. Well-defined QA and QC roles and compliance to cGMP mean that only the appropriate materials are sent for production or shipment while the inappropriate ones are rejected and sent for quarantine. NC, CAPA, Inspection plans, Adverse Event Reporting, BMR, MBR, etc. are other features that cannot be missed in a Pharma ERP solution.
Lot traceability – Pharma manufacturing SMEs need to keep a close eye on every part of their manufacturing process, because if anything ever goes wrong, they quickly need to identify exactly what, where, and when happened in their manufacturing plant. A pharmaceutical ERP software comes with lot traceability feature, and allows the manufacturers to trace ingredients all the way through the supply chain- from procurement to final sale and vice versa. This allows them to manage any recall situation, and make swift product recalls when necessary. Besides, it also gives the manufacturers feasibility to perform mock recalls, a mandate these days. This even allows a 360 degree view into a product lot’s activity, and ensure each lot remains distinct in subsequent operations.
Inventory & material management – The aim today of any pharma manufacturers is to produce drugs that are high on quality and low on price. Any good pharma ERP software allows manufacturing SMEs to control material wastage and monitor inventory levels through its dedicated inventory & material management features thereby ensuring greater profit margins. It helps the manufacturers identify material required for production, set targets, create triggers for procurement and replenishment, monitor material usage scientifically, reconcile inventory balances, and formulate inventory status reports in a timely manner. By calculating when, what and how much to produce and procure, the system keeps the inventory always optimized shunning the situations of over or understock. It even supports the first expiring, first out (FEFO) approach to inventory management, which in turn allows the manufacturers to maintain consistent quality, and avoid the risk of selling an expired product.
To sum up
The pharma manufacturing SMEs today know that having a pharmaceutical software is no longer a luxury for their business, but an absolute necessity. It has emerged as a tool that helps the pharma manufacturers address their business challenges, deliver healthcare products of supreme quality at compelling prices, reduce cost, streamline operations and maximize efficiency. One such software, which comes loaded with all the aforementioned features, and checks all the boxes for pharma manufacturers, is BatchMaster ERP for pharmaceuticals – a software tailor-made for the pharmaceutical industry and is apt in handling the need of contract manufacturing too. Get in touch with our team of experts for guidance on how the software can work wonders for your pharma manufacturing small & medium enterprise.