Potency Management for Pharmaceuticals in Sage X3 Sage X3 Tips, Tricks and Components

Some things to think about include built-in forms, predefined workflows, and other features designed to simplify compliance management. Accelerate process cycle times and control quality get accurate costing and pricing, real-time control over production planning, and adapt quickly to new regulations. One of the most important elements of supply chain transparency and compliance is ensuring that there are sound quality assurance processes in place.

A business case outlining the costs, expected benefits, and ROI of an ERP implementation is an integral part of initiating an ERP project. 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. There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data.

Achieve Operational Efficiency & Manage Your Business On A Global Scale

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. I think the bottom line is that investors have not placed heavy value on the PPD market as of yet. Not only that, it has not even valued in the potential for SAGE-718 either, which is being used to treat various types of neuropsychiatric disorders either. All it needs with SAGE-718, in my opinion, would be to succeed with at least one of the four indications being sought out for.

sage x3 pharmaceuticals

Some results of this drug targeting these other patient populations could also be released in 2024. While the HD indication is not a multibillion-dollar market opportunity, the AD and PD indications are. Hopefully, the biotech will be able to expand its presence towards these other neuropsychiatric disorders. It remains to be seen how ZURZUVAE will do on the market for PPD when it is released, but the reason why I believe it is important to highlight this biotech again is because there are several opportunities for it to recover. Especially, for the fact that there are 3 ongoing studies using its drug SAGE-718 for the treatment of patients with Huntington’s Disease [HD].

Computer System Validation (CSV) Use Case with Performance Validation

NexTec Group is an award-winning business software consulting firm with over 25 years’ experience. We specialize in implementing ERP and BI solutions that can manage product recalls and customer issues, track products, reduce waste and improve operations. Therefore, it is critical that your ERP system aid in creating and protecting these critical assets. A pharmaceutical manufacturing ERP must be able to document various ingredients, their storage, the manufacturing process, pH values, particle size, and much more – along with the ability to review it at any given moment. Additionally, the system will need to track any revisions made to the formula, scale it to batches, and more.

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With this one cohesive suite of applications management of company software is simplified. Not only that, but there is also an opportunity I laid out before with respect to SAGE-324, which is being advanced for the treatment of patients with essential tremor. This is not a large market opportunity like the other indications noted above, to be valued around $224.7 million in 2028, but could still be a good addition nonetheless.

The following components detail the PV solution:

According to the 10-Q SEC Filing, Sage Therapeutics had cash, cash equivalents and marketable securities of $1.1 billion as of June 30, 2023. However, as I noted above, it was not able to obtain FDA approval of ZURZUVAE for the treatment of patients with MDD. The what is sage x3 reason on why it is important to highlight these particular studies is because there are several of them for HD that are going to be released in 2024. Not only that, but as I stated above, SAGE-718 is also being developed to treat patients with PD and AD as well.

  • Managing inventory is a basic feature of any ERP system, but make sure yours allows you to follow the FEFO (first expired, first out) approach to inventory management.
  • A third risk to consider would be with respect to the launch of ZURZUVAE for the treatment of women with PPD, which is expected to take place in Q4 of 2023.
  • There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data.
  • Each company must determine how to do so and provide evidence that is has been done and that the software meets FDA requirements.
  • Sage X3 accelerates your entire business, and delivers faster insight into costs and performance at every step, on a global scale.
  • Sage ERP X3’s Pharmaceutical vertical addresses these unique and specialized needs of Pharmaceutical Manufacturers.

Whether it’s pharmaceutical or nutraceutical, life sciences companies span a variety of different disciplines including research and discovery, production, supply chain, and distribution. 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. Ideal for enterprises in manufacturing, distribution, wholesale, retail and service industries.

Need for better quality assurance

Recently, a medical technology company was upgrading their enterprise resource planning (ERP) software system to the latest Sage X3 platform in order to improve their efficiencies in accounting, distribution, and manufacturing. They would be implementing the Sage X3 platform as a SaaS (Software as a Service) with a browser-based interface. The scope of the system implementation was to include warehouse, customer care, field service, purchasing, planning, manufacturing, document control, handheld scanner, and quality control components.

sage x3 pharmaceuticals

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.

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This set of components aids companies in meeting regulatory compliance and has been MHRA audited. Managing inventory is a basic feature of any ERP system, but make sure yours allows you to follow the FEFO (first expired, first out) approach to inventory management. With a team of developers and certified consultants working across continents, SynergERP offers support on an international scale. SynergERP will ensure that our industry knowledge, employee expertise, and cutting-edge technology solutions work harmoniously to elevate your business operations and customer satisfaction. Take the product tour to see how Sage X3 supports key business processes and diverse company roles. Sage Therapeutics, Inc. has great potential left in its pipeline, despite the fact that the stock has traded lower on the back of it not obtaining FDA approval of ZURZUVAE for the treatment of patients with MDD.

Sage ERP X3’s Pharmaceutical vertical addresses these unique and specialized needs of Pharmaceutical Manufacturers. With regards to the current COVID-19 pandemic drug manufacturing industries are pressed with the issue of producing a drug as soon as possible. Proactivity will help in identifying loopholes, restocking and replenishing inventory items, identifying, predicting and addressing quality issues, and monitoring safety and maintenance. 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. Performance Validation’s experience with creating testable User Requirements from various inputs helped expedite that portion of the project. PV generated initial drafts of the test protocols by exploring the software, help menus, and forums initially.

SAGE-718 For Neuropsychiatric Disorders Can Still Bring Enormous Value

Sage X3 offers flexible configuration and deployment options which means it can be set up to support your industry-specific processes. The fourth and final risk to consider would be with respect to SAGE-324, which is being advanced with Biogen in the phase 2b KINETIC 2 study for the treatment of patients with essential tremor. There is no assurance that proof-of-concept in using this drug for the treatment of these patients will be established. A third risk to consider would be with respect to the launch of ZURZUVAE for the treatment of women with PPD, which is expected to take place in Q4 of 2023. That’s because while this is a good market opportunity, which is expected to reach $55.28 billion by 2030, there is no guarantee that it will gain traction upon release.

sage x3 pharmaceuticals