PV generated initial drafts of the test protocols by exploring the software, help menus, and forums initially. The team then began scheduling time with individual SMEs for respective business areas for support in drafting the test scripts in a manner that ensured that the testing would be reproducible. Final drafts of all test protocols were entered into client’s document management system to be routed for approval. With regards to the current COVID-19 pandemic drug manufacturing industries are pressed with the issue of producing a drug as soon as possible.
A good example of this can be found in the built-in forms and predefined workflows for compliance management offered in many pharmaceutical manufacturing ERP-oriented systems. Whether you need to optimize efficiency, manage compliance, or meet regulatory standards, there is software to address your needs. In fact, there are fully integrated ERP solutions for pharmaceutical manufacturers that manage everything from accounting to customer relationship management to manufacturing to sales and beyond.
Sage X3 FDA Compliance Validation
Sage X3 Pharmaceutical Preparations allows you to capture all of the data relevant to your manufacturing processes, including those inspected for FDA compliance. Automated reporting features enable you to review information at each processing stage to identify potential instances of noncompliance and address them before submission to regulatory agencies. With the X3 bundled is sage x3 cloud based solution, you can deliver electronic records as needed to fulfill FDA reporting requirements. Even if you are not in an FDA regulated industry, validation is still a good idea for businesses that want to improve quality. FDA software validation helps manufacturers reduce risk and ensure their products are produced and distributed according to high quality standards.
- There are many add-on products designed to extend the functionality of existing systems to handle specific tasks like R&D management, compliance tracking, or quality control.
- Automated reporting features enable you to review information at each processing stage to identify potential instances of noncompliance and address them before submission to regulatory agencies.
- In addition, Sage X3 chemical manufacturing software provides a powerful unit-of-measure conversion engine for managing complex metric measurements or conversions from liquids to solids or gases to liquids.
- It is worth noting that we have since performed several other Sage X3 validations completely remotely, without any onsite execution.
- Whether it’s pharmaceutical or nutraceutical, life sciences companies span a variety of different disciplines including research and discovery, production, supply chain, and distribution.
- Therefore, the ability to understand the potential return on your investment (ROI) before making that investment is invaluable to any enterprise.
Therefore, the ability to understand the potential return on your investment (ROI) before making that investment is invaluable to any enterprise. A recent study on “The Total Economic Impact of Sage X3” has demonstrated an impressive 177% ROI on using Sage X3. Process Manufacturing – One of the important functions in a Pharma company is the manufacturing of medicines. Even in helping to keep a record and streamline the manufacturing process, Sage ERP Solutions helps the manufacturers to keep service consistent and produce greater output.
Compliance is business-critical and companies operating in the Pharmaceutical industry must ensure:
It can ensure enhanced efficiency in the wake of a pandemic when time is crucial to life. A module specifically designed to manage quality control activities will give you all the tools you need to ensure you’re delivering the same quality product each time. Workflow management functionalities provide checkpoint tracking in your manufacturing process to identify when samples should be taken for quality control tests. Sage X3 can handle your entire product lifecycle, from conception through approval through manufacturing.
On completion of the system documentation, the PV team accelerated their effort toward writing of the test protocol to ensure adherence to the client’s timeline for implementation. Validating software involves establishing documented evidence that proves the software consistently meets predetermined specifications and quality attributes—that is satisfies its intended use. And even though most software is purchased from a third-party, the third-party vendor is not responsible for validation. Sage recently implemented an X3 solution at Shire Pharmaceuticals, one of the world’s fastest-growing pharma companies that specializes in solutions for behavioral health, gastrointestinal illnesses, regenerative medicine and rare diseases.
Four Scenarios that Smart Manufacturing Enables for Pharmaceutical Industry
Rigorously enforce inspections and ensure your products conform to required characteristics, operational tolerances or expected results. Conduct inspections at key event points or throughout the production and packaging processes, and automatically quarantine suspicious or substandard items for further inspection or disposal. The rules-based orientation of Sage X3 prevents usage of any item that lacks an acceptable quality status.
With many packages, you’ll also be given the option of creating custom reports or managerial dashboards. Producing consistent, high-quality pharmaceuticals that comply with regulations is another critical success factor for manufacturing companies in this industry. Make sure your system supports each step of the process and allows you to request quality control tests, track the results, and take corrective action.
Sage X3: ERP Software for Pharmaceutical Manufacturers
The ERP Pharma also offers interactive dashboards for highly transparent statistics and automated processes. The composition of drugs requires precise set of formulas to achieve the best medicine which is relative to a set of prioritized constraints. Smart manufacturing maximizes factors such as productivity, strength, reliability and efficiency with automated workflows, synchronization of assets, improved tracking and scheduling, and optimized energy consumption. It also reduces hazardous medical waste possibility as each step is measured accurately thus, increasing optimization.
Manufacturing of drugs involve complex individual sub-processes which are difficult to optimize in the absence of an ERP. Sage X3 Discrete Manufacturing Suite for medical device manufacturers supports the production of discrete units in configure-to-order, make-to-order, assemble-to-order or make-to-stock environments. Stay on top of new regulations and raise the quality bar with industry-specific food and beverage ERP software. Preserving its difference in the market is key for your company to remain competitive and grow. Your organization, processes and the unique way you manage your business significantly contribute to your difference.
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Your pharmaceutical company needs the right enterprise resource planning (ERP) solution to meet changing regulatory expectations and to achieve the efficiencies in supply chain management that drive productivity. The Sage X3 Pharmaceutical Preparation bundled solution captures and delivers the data necessary to maintaining compliance with FDA regulations for drug manufacturing. Applying X3’s extensive functionality allows you to trace all production processes as well as the lifecycles of all product batches created. Just as with several other manufacturing sectors, the FDA imposes stringent labeling requirements for pharmaceutical preparation. However, drug manufacturers may face varying regulatory obligations for ingredients that experience significantly different perishability rates that can affect end product shelf lives.
There are several ERP systems on the market designed to address the specific challenges facing pharmaceutical manufacturers. When you’re a pharmaceutical manufacturer, however, it doesn’t always feel that way – it feels like you’ll never find the solution that’s right for your business. Be sure that the system helps you remain in compliance with the many other requirements set by the various regulatory agencies you undoubtedly report to. Some things to think about include built-in forms, predefined workflows, and other features designed to simplify compliance management.
The Construction and Agricultural Market Conditions Affecting Equipment Manufacturers
With increased pressure from consumers and regulators on transparency and compliance, life sciences organizations are prioritizing data sharing and automation more than ever before. In our guide, we will cover industry trends, challenges, and process solutions and how an ERP solution can support businesses in the sector. Sage X3 pharmaceutical and life sciences functionality delivers industry-specific capability with the flexibility to accommodate your specific business requirements.
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. The Sage X3 ERP validation was completed ahead of schedule, meeting the customer’s overall system implementation deadlines. The company gained awareness of gaps in their procedures and security and resolved them. PV completed the validation effort by practicing excellent documentation standards, testing processes, and a focus on the customer needs. This medical device company now has an ERP system that is compliant with FDA regulations for computerized systems.
Why Sage X3 is ideal as a pharmaceutical ERP
The system offers a visual finite scheduling tool that can be used manually, or you can choose to let the system put together the best schedule. Back-office accounting functionality integrated with your pharmaceutical manufacturing package will encompass features like accounts payable processing, receivables management, financial reporting, and budgeting. If you’re running R&D projects, you’ll be able to track project costs through cost accounting features. It’s a common practice in Pharmaceutical manufacturing businesses to buy raw materials in one unit of measure, store them in warehouses in another, convert them into finished products in one more, and finally sell them in another.