In pharmaceutical companies, one of the biggest challenges is understanding and meeting quality, compliance, and regulatory challenges. The companies are under peer pressure to resolve these challenges and change their practices to set their standards as per government regulations. Also, violating these rules lead to getting FDA 483 letters from the concerned bodies.
To resolve all these challenges one of the best solutions is implementing ERP software. The software offers excellent compliance and regulations-related features that help in crisis management and also aid in managing the risk management of the company products. The software also offers companies a systematic strategy to make regulatory-related changes in business operations.
All-in-all, Pharma companies can easily streamline and manage their production and operation in the functions of the business. The pharma erp software also helps in mitigating business risks and also improves the decision-making capability of the business.
In this blog, we will see how an ERP can help pharma companies to ensure compliance and regulations.
It is a very effective feature of pharma ERP which helps companies to trace their medications while also removing counterfeited and recalled medications. The feature records every single data on a particular product quantity and makes it easy to trace raw materials within a specific product batch. This process explains the expired batches and exactly which batch is now ready for purchase. It also indicates which batch needs a recall based on certain events.
In pharmaceutical companies purchasing materials from verified and certified vendors is key. ERP software helps to keep all records of the material purchases made. The best benefit of having an ERP in the pharmaceutical industry is that the software saves every record of discounts given by the vendors along with their date and time. It also sends alerts and notifications to the businesses about the expiry of the materials which apparently improves the quality of Pharma products while ensuring better compliance.
Pharmaceutical companies require real-time data access to all vital information to enhance performance. With accurate data, companies can monitor and reduce the impacts of non-compliance efficiently. The implementation of ERP software in the pharma manufacturing plants ensures better management of complex factors along with following the rigorous industry guidelines as well as practices.
Every pharma company requires detailed and accurate documentation since it builds a greater level of transparency and also resolves concerns too quickly. Generally, the documentation involves all data about the regulations that need to be complied with, vendor data, QC reports & specifications, inventory details, installed systems details, and more. ERP software is capable of generating all such data streamlined with product labels, batch manufacturing records, and more.
Quality standards have the highest importance in a compliance-regulated workplace for pharma companies. ERP software offers a comprehensive framework to manage product innovation with precise data management with better quality process controls. The software addresses a number of issues including resolving quality issues quickly by saving time as well as effort and improving the bottom line. Also, with the help of ERP software, if a quality check test is failed, companies can perform CAPA (Non-conformance and Corrective and Preventive Actions). It also helps with stability testing, sampling plans, batch monitoring activities, and frequent inspection plans which eliminates the need for rework.
The manufacturing sector requires data security at every phase be it formula generation, generating sensitive reports, user details, etc. Hence data breaching is the biggest concern among pharma companies nowadays. ERP software has special features like an audit trail which keeps all records about each update made along with the time and date. For better security of transactions, an authorized operator is assigned who also creates a detailed log of all audit transactions while keeping all data completely secured.
An ERP software can manage documentation quality compliance and other major concerns of the manufacturing business. Hence companies can easily focus on other factors like customer relationship management. The more transparent a business process the more satisfied the customers can be. The software also offers sample management while also allowing the tracking of customer complaints in an effective manner.
As per the DEA rules, drug distributors as well as manufacturers must design and deploy a system that can determine suspicious ordering activity of controlled elements like medicine. As per the regulations, distributors and manufacturers may create and utilize a system that reports suspicious orders to the local DEA. The regulation determines unusual size orders, orders of unstable frequency, orders that are very different from the normal ones, etc. ERP software can help pharma companies to monitor, track, and report any dubious orders and can also help in blocking the shipment of controlled elements.
Medications play a very important role in our lives and hence it is quintessential to follow the guidelines offered without any errors. The ERP application can help pharma companies in formulating ingredients that are very impactful and cost-effective to stay on par with competitive prices. Also, the software is required to maintain a sturdy database of consumption, compositions, raw materials, and more.
As far as the health of humans is concerned, the pharmaceutical industry must be alert to the latest government notices or announcements along with the development of standard medical associations. Hence, to stay updated with all compliance-related policies and medical standards, the enterprise resource planning system can help. The system can easily manage comprehensive guidelines during any dynamic transformation in the compliance sector.
An improved compliance and regulations strategy can give strong positive and remarkable advantages to Pharma’s business operations. Once a Pharma business meets the compliance and regulations requirements the complete supply chain of the business gets improved and a considerable amount of growth can be seen in sales. The above-mentioned role of ERP in the pharmaceutical industry cannot be overlooked since all these benefits are quite prominent and ensure excellent business growth. These advantages will take pharma companies to become more sustainable and have flexibility, scalability, and customization.
Deepali Daiya is a communication expert who excels in understanding customer needs. She writes powerful sales scripts and articles with very high conversion rates. Currently, she is associated with Sage Software Solutions, a leading distributor of high-quality ERP system and CRM systems to small and mid-sized businesses in India.
Twitter Profile:- https://twitter.com/2021Deepali