It makes it possible to handle quality assurance, inventories, finances, sales, and research and development effectively. ERP Software for pharmaceutical industry helps connect, integrate, and control each department in the chemical company while also automating all pharma manufacturing functions like inventory, planning, etc. Mandatory government regulations make product traceability essential for pharmaceutical companies. Therefore, pharma companies must maintain a detailed record of all product transactions, including historical purchases. They also need to track the movement of goods — raw materials from the vendor to the inventory of pharmaceutical company and finished products from the warehouse to the end-user.
You can also assign an expiry date to the batches that have been produced through the First Expiry First Out (FEFO) basis. GerminIT’s Sage X3 team identified order processing and inventory verification as non-value-adding process steps which caused cost escalations. The pharmaceutical company’s orders range from single-use home-based consumption to bulk supplies. The pharmaceutical company retails the supplements from more than 30 stores with order volumes increasing at an exponential rate..
Pharmaceutical Manufacturing Regulations Solved by Sage X3
PV created a Requirements Traceability Matrix to document where each user requirement was qualified as evidenced by either testing or vendor documentation. Focused on the unique and specialized requirements of mid-sized process manufacturers in Food & Beverage, Chemicals, Cosmetics, Pharmaceuticals and related industries. Compare and evaluate your options for business management systems with the interactive and informative Chemical Manufacturer’s Technology checklist. There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data.
Sage X3 chemical software supports the demanding industry-specific functionality required by chemical manufacturers and distributors to streamline processes and ensure quality and compliance. You can convert leads or prospects to customers and use Projects to track opportunities. With the addition of workflow, the status of the project is tied to a person in the company. When entering an order, you can check the inventory of the finished good and the components inventory when the manufacturing order is created. The software can track internal or external development projects and can be attached to quotes. This means you can internally track sample requests as they’re processed and shipped to customers.
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The compliance management functionalities available within pharmaceutical ERP packages are designed specifically to help you meet the requirements set forth by regulatory agencies. The ability to assign tasks to particular individual staff members is an important aspect of creating accountability in managing for compliance. The beauty of using a pharmaceutical management package is that the developer built the system with your business in mind.
Having the right pharmaceutical ERP in place lets your company optimize operations, ensure accuracy and compliance and create efficiencies that boost the bottom line. In 1979 a French company called Société Parisienne de Micro-Informatique (SPEMI) was founded and they produced accounting software for Sord computers. The software was redeveloped for use on UNIX systems and a custom development tool was developed called Accès aux DONnées sous is sage x3 cloud based unIX (ADONIX).[4] Adonix Entreprise V2 was written on that platform. Sage X3 is an enterprise resource planning product developed by Sage Group aimed at established businesses.[2] The product was formerly known as Sage ERP X3 and is available in many of the territories that Sage operate. Regulations are there to ensure the safe and controlled running of the industry, but can often end up becoming a daunting task for mid-sized enterprises.
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Pharma ERP software is a versatile software that automates various pharmaceutical processes such as production and quality assessment, formula management, cost budgeting, lot tracking, and marketing. It records product expiry, corrigenda, non-conformances, and other related data to provide end-to-end traceability and track the movement of products throughout the manufacturing process. Businesses can comply with stringent regulatory requirements to meet the highest standards of quality and safety. ERP in pharmaceutical industry is a term used to describe sophisticated software systems created to connect and streamline numerous business activities within pharmaceutical firms.
This enables departments to work as a cohesive force and further the interests of the company. A single window enables pharma companies to handle everything from one place and save time, effort, energy, and resources. At Greytrix Australia being Development Partners for Sage, we address complexities of pharmaceutical industries with aforesaid features. The FD&C Act dictates that measurement information (dosage, etc.) be included on all drug package labeling or that product will be ruled misbranded. Implementing Sage X3 Pharmaceutical Preparation allows you to keep track of all the data pertaining to raw material usage up to each batch processing and captures this information within the system. Take advantage of Sage X3 sophisticated wholesale trade ERP and inventory allocation routines and automated landed cost calculations.
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Sage X3 ERP for pharmaceutical manufacturing also takes product variations into account. When solid converts into liquid or vice versa, its size, volume, area, potency, and other characteristics change. Sage X3 maps different Units Of Measure (UOM) with appropriate costs across the entire manufacturing schema and make measurements convenient. With the Sage X3 ERP for pharma industry offers a comprehensive suite of solutions that streamlines the entire process for achieving and maintaining compliance with the various regulations. Download our free E-book to learn more about Sage X3 Pharmaceutical Preparation, powered by Sage, and how this solution can ensure you achieve compliance in pharmaceutical manufacturing. Performance Validation provided the client with consultation through understanding the software, the stakeholders and their needs, and proposing the best fitting validation strategy for an Enterprise Resource Planning solution.
- Pharmaceutical products also require additional information to be displayed on labeling that is not common in other manufacturing verticals, including directions for safe use such as whether it is appropriate for children under a certain age.
- It can ensure enhanced efficiency in the wake of a pandemic when time is crucial to life.
- Sage 300 makes optimum utilization of all available resources, the result is higher efficiency and better performance.
- Considering the present situation, it has become a challenge for Pharma giants to come up with a possible vaccine to defeat COVID-19.
- PV generated initial drafts of the test protocols by exploring the software, help menus, and forums initially.
Pharmaceutical manufacturing is heavily regulated by the FDA through the Food Drug & Cosmetic Act (FD&C Act). Drug manufacturers and distributors are increasingly coming under the jurisdiction of widespread federal laws such as the Drug Supply Chain Security Act (DSCSA) that impose more stringent compliance requirements. Navigating the regulations in the pharmaceutical manufacturing industry requires being able to deploy business management solutions that capture end-to-end supply chain visibility for the delivery of accurate production and processing system data. Meet the pressure to stay competitive and remain compliant with an increasing array of regulatory requirements with ERP functionality designed especially for the challenges of your industry. Sage X3 pharmaceutical and life sciences functionality provides manufacturers in pharmaceuticals, nutraceuticals, medical devices with an industry-specific solution to manage your most elaborate business processes and stringent requirements.
Sage X3 ERP for Pharmaceuticals Industry
It can also track lot properties while optimizing and improving other business processes like batch production, sales functions, inventory control, purchasing, quality assurance, accounting and financials, regulatory reporting etc. Tracking operational, material and manufacturing costs manually are challenging for pharmaceutical companies. On the other hand, ERP application in pharmaceutical industry calculates the final product cost by accounting for R&D cost, raw material cost, customer incentives, insurance costs, and much more. Managing inventory is the major aspect of ERP software because finished products in pharmaceutical industries come up with an expiration date. The drugs are delivered on first come first out so that they reach the end consumers before the expiry date.
Managing production activities and providing insight into exactly what happened and when it happened is crucial to achieving product traceability. Your ERP system must be able to trace product origin, its path through the production process, and its final destination. This requires a recall plan directly into the system, data accuracy and traceability throughout the supply chain, documentation and retrieval of testing results on ingredients and finished goods, and more. Such transparency into materials is crucial to quality control and recall, should a situation call for it. Sage 300 makes optimum utilization of all available resources, the result is higher efficiency and better performance.
Quality Control In The Pharma Industry
The DSCSA necessitates the implementation of track-and-trace systems that can provide the full historical data of a product on-demand. This can be achieved by deploying the X3 Pharmaceutical Preparation bundle’s traceability features to provide comprehensive audit trails for products. Utilizing this bundled solution’s data tracing functionality allows you to deliver the full history of an end product to its original processing batch. All companies in FDA regulated industries are legally required to validate software if that software could impact product quality, safety, or effectiveness. Fully integrated manufacturing, distribution and accounting functions drive productivity; the sophisticated finite capacity planning tool optimizes shop floor scheduling.
Data captured from multiple sources like finished or still-in-production stages can be converted into actionable insights to estimate cost, deliverables, production, raw materials etc. A transparent system enhances visibility across departments by providing tools such as role-based views, real-time alerts and notifications, and real-time tracking and monitoring. Sage X3 equips businesses in the pharmaceutical and nutraceutical industries with the tools necessary to compete in this highly competitive environment. As pressures mount for lower prices and greater regulatory reach, companies must still focus on improving thinning pipelines and managing rising operational costs.
To answer those key questions, let’s take a look at some of the pharmaceutical ERP requirements. You may have other requirements depending on your specific needs, but that list should get you started. Once you’ve nailed down your requirements list, start to consider the modules and capabilities you will need in an ERP solution. All of these challenges amount to an increasing pressure to maintain competitiveness while simultaneously complying with an increasing array of regulatory requirements. Supply chain traceability is an important component to regulatory compliance, especially with an endless number of new and updated guidelines. So, you can update different Pharmacopeia, such as the Indian Pharmacopeia, US Pharmacopeia, using Sage X3.