MAXLife

10
Jul

Biopharmaceutical Company Rapidly Implements Dynamics 365 To Drive Growth

Biopharmaceutical Company Rapidly Implements Dynamics 365 To Drive Growth

This confidential organization is a clinical stage publicy traded biopharmaceutical company pioneering immunotherapies for life threatening and debilitating diseases that have been underserved by scientific innovation. The company’s mission is to help patients with serious diseases and few therapeutic options to combat cancer and other serious illnesses.



Fast Facts

Industry:
Biopharma

Location:
California

Existing Systems:
NetSuite

Evaluated Systems:
Microsoft Dynamics 365, Oracle

System Selected:
Microsoft Dynamics 365

THE SITUATION

As a five year old clinical stage biopharma company, this client had been running their business on the NetSuite ERP platform. However, with their lead program entering phase three for two indications and receiving orphan and breakthrough designation from the FDA, the company began to outgrow the NetSuite ERP platform as it no longer provided the scalability and visibility needed for long-term growth. With plans to grow from 70 to 200 people and to bring move 95% of manufacturing internally – the company wanted unified cloud based platform that integrated all areas of the business – with a heavy focus on manufacturing and supply chain – and could be implemented in phases with a rapid go live.

Disparate Systems Could No Longer Support Growth

MERIT’S SOLUTION

Executives at the company evaluated two potential NetSuite replacements – and ultimately chose the Microsoft Dynamics 365 platform over Oracle. The unified platform from Microsoft, which brings together capabilities for ERP, CRM, BI, IoT, Quality, and more, was a major differentiator for the company. The MAXLife365 and Rapid365 offerings from Merit Solutions were also clear advantages. Prior to evaluating Rapid365, the company was not aware that Microsoft Dynamics 365 could be deployed in a pre-configured / best practices / rapid implementation model. Considering that they were moving from a similar model with NetSuite and had a tight timeline to go live with financials, this was a determining factor that led them to choose Microsoft Dynamics 365 and Rapid365 over Oracle.


Expected Benefits:

  Implement modern technology that can deliver relevant and actionable business intelligence across the company.

  Increase ability to support aggressive growth and expansion goals.

  Streamline and automate manual and inefficient processes.

  Increase product quality and reduce the cost of maintaining compliance.

  Extend visibility and access into financial and supply chain data – reducing costs and increasing shareholder value.

  Increase ability to forecast, plan, and make informed decisions.

  Bring manufacturing in-house and drive effective supply chain processes.

Microsoft Dynamics 365 - Improve Decision Making


Trust Merit Solutions with your Life Sciences Industry Projects.

  Life Sciences Experience

We have been implementing, integrating, and customizing Life Sciences ERP and mobile applications for more than 10 years.

  We Know Validation

We understand the rigors of designing and deploying validation-ready systems.

  We Know Support

Our MeritCare team has been providing clients with issue resolution, ongoing support, managed and systems optimization services for years.

  Proven Implementation Methodology

We have a proven implementation methodology – both for enterprise transformations and rapid, pre-configured, and best practices deployments.


Contact Us Today

If you're interested in learning more about Microsoft Dynamics 365, Rapid365, MAXLife, or mobile applications for the Life Sciences Industry - please contact us now!

10
Jul

Dental Products Company Implements Dynamics 365 To Drive Growth

Dental Company Implements Dynamics 365 To Drive Growth

This confidential organization is a worldwide developer and distributor of high-tech dental and orthodontic materials, devices, and instruments. With a mission to improve the level of dental healthcare and to make dental procedures more predictable and hassle-free, this company employs roughly 1,600 employees worldwide and is FDA compliant, ISO certified, PCI compliant, and follow GMP. They have experienced non-stop growth for over 30 years!



Fast Facts

Industry:
Medical device

Location:
Utah

Existing Systems:
Oracle

Evaluated Systems:
Microsoft Dynamics 365, Infor

System Selected:
Microsoft Dynamics 365

THE SITUATION

This dental products company had been using a number of systems across the company to operate – including different systems for ERP, CRM, PLM, HRMS, LIMS, MRP, WMS, label printing, credit card processes, sales tax and more. As the company planned for increased growth and expansion, executives determined that the company needed a more modern and unified business platform that was more affordable, scalable, and flexible – with a path to a GMP-compliant cloud architecture.

Disparate Systems Could No Longer Support Growth

Microsoft Dynamics 365 for Pharmaceuticals

MERIT’S SOLUTION

After evaluating the Microsoft Dynamics 365 and Oracle business platforms, executives ultimately chose to implement the Microsoft platform with Merit Solutions. Executives chose Microsoft Dynamics 365 because it better addressed their critical project requirements, including: support for discrete, process, and lean manufacturing; it could be rolled out in phases across the globe; it is cost-effective and can be scaled and used for the next 15+ years; it is compliant with FDA, ISO, PCI, and GMP guidelines. The company also wanted to work with a partner with deep Life Sciences industry expertise and with global delivery capabilities. Merit Solutions’ unique IP, MAXLife365 and Rapid365, were recognized as a key value and ROI drivers for the company.


Expected Benefits:

  Unite and serve all sales and operations employees across the globe.

  Reduce the cost of meeting FDA, ISO, or GMP requirements.

  Increased agility to address changing markets, user or regulatory requirements.

  Improve performance through data intelligence – utilizing mobile and IoT friendly systems.

  Provide employees with easier, yet secure, access to the data they need to perform with higher quality.

  Increase ability to scale and grow unencumbered by business systems.

  Continuously drive platform ROI as the system grows within the business.

Microsoft Dynamics 365 - Improve Decision Making


Trust Merit Solutions with your Life Sciences Industry Projects.

  Life Sciences Experience

We have been implementing, integrating, and customizing Life Sciences ERP and mobile applications for more than 10 years.

  We Know Validation

We understand the rigors of designing and deploying validation-ready systems.

  We Know Support

Our MeritCare team has been providing clients with issue resolution, ongoing support, managed and systems optimization services for years.

  Proven Implementation Methodology

We have a proven implementation methodology – both for enterprise transformations and rapid, pre-configured, and best practices deployments.


Contact Us Today

If you're interested in learning more about Microsoft Dynamics 365, Rapid365, MAXLife, or mobile applications for the Life Sciences Industry - please contact us now!

27
Mar

Life Sciences Businesses Need More Than Simple ERP Systems

Life sciences companies are facing increased competition and experience periods of fast growth, especially after receiving FDA approval for a new product. As if that’s not challenging enough, there is increasing regulatory oversight which can be a distraction from core business processes. Early-stage and in-market life sciences organizations need more than entry-level software, but don’t need to invest heavily in costly ERP systems. Deploy a management solution that is flexible, agile and can support unique business operations today and well into the future.

Read more

13
Mar

Quality and Traceability Matters in Life Sciences Industry

Pharmaceutical, biotech, medical device manufacturers and other organizations in the life sciences industry provide life-changing products and value to customers. High quality products are expected and there is little room for mistakes, especially when a mistake can impact patient safety or health. Traceability requires close attention to detail and speed when a recall must be initiated. A digital business management solution will strengthen inventory management and the supply chain, as well as expedite the identification of each component with a quality issue.

As indicated in “Life Sciences: 6 Ways to Thrive in a Digital Future,” an eBook, minutes matter when it comes to saving lives. For life sciences organizations, managing quality issues for every component and every device is crucial, no matter whether they are located in house or at a customer site. Strong traceability requires close collaboration with supply chain partners and the ability to capture detailed product history documentation for each product. This level of data management simply can’t be trusted to spreadsheets or specialty software. Life sciences organizations need a unified, digital management platform, like MAXLife.

Read more

3
Mar

Get a Single Source Version of the Truth to Minimize Risk and Optimize Operations

Successful life sciences businesses cannot rely on disparate, specialty software for very long. Without real-time, reliable data, companies simply can’t respond fast enough to deviations in plans or take advantage of new opportunities. A centralized, integrated business management solution will provide a single source of the truth, providing the data leaders need to make decisions that improve operations, boost productivity and profitability, and drive growth.

Read more

22
Feb

Microsoft Dynamics 365 Life Sciences Webinar Series

Join sponsors Microsoft Corporation and Merit Solutions for an executive webinar series for biotech, pharmaceutical, and medical products companies: Leading Life Sciences to Success in a Digital Future.

This webinar series will discuss the impact a unified, digital technology platform can have on organizations – including heavily regulated Life Sciences companies.

To learn more, visit our webinar series page: Leading Life Sciences to Success in a Digital Future.

Or register for individual webinars using the links below:

Read more

13
Feb

Don’t Let Fast Growth Impact Profits or Productivity

After years of securing investors, performing product design and testing, and submitting documents to the FDA, many life sciences organizations suddenly find themselves in a period of fast growth after receiving FDA approval. Product approvals force pharmaceutical, biotech and medical device manufacturers into the next phase, which is manufacturing high quality products quickly, efficiently and profitably. Life sciences organizations can manage the entire process, from start to finish, by replacing inefficient business systems with a more modern management solution.

Change can happen, literally overnight, at many life sciences organizations. After receiving FDA approval, you need to jump into action setting up manufacturing operations to get your innovative new product into the marketplace as soon as possible. As discussed in “Life Sciences: 6 Ways to Thrive in a Digital Future,” an eBook, being prepared for strong, fast growth after approval is no small task. Replace entry-level or niche systems with a business management solution that can streamline the transition from the research and development phase to production and sales.

Read more

13
Jan

Life Sciences Organizations Succeed Under Pressure with Digital Transformation

Pharmaceutical, biotech, medical device and other life sciences companies are under increasing pressure to succeed in a highly competitive and regulated marketplace. There is no room for error, especially when delivering life-changing products to customers. An integrated business platform for ERP, CRM and BI can optimize operations, support all phases of growth and deliver the very data needed to succeed.

Read more

17
Sep

Osmotica Pharmaceutical Turns to MAXLife for Efficiency, Effectiveness, and Compliance

Donna-Lenning

What challenges / business issues were you experiencing that made you consider a new ERP platform? 
We were either executing all business processes manually or with simple automation such as QuickBooks for financial processes. In order to prepare for the planned growth, our leadership decided to begin the implementation of Microsoft Dynamics AX in 2012 in order to have a fully automated process experience in the organization.

What value did Merit Solutions provide during systems validation? 
Merit Solutions facilitated the User Requirements gathering process, assisted with documenting those requirements as well as the functional configuration and design documentation. They reviewed the Operational Qualification protocols and then provided valuable on-site assistance during the execution of the Operational Qualification protocols as the functional and technical resources to resolve all discrepancies during the execution. They also reviewed the installation qualification and provided remote support during the execution of the IQ. Lastly, they assisted with end user training and production cutover activities as we worked through the transition from manual processes to automated processes.

What other benefits have you realized since implementing MAXLife with Dynamics AX? 
We now have lifecycle management of our raw materials release process from planning to purchasing to receiving to testing and finally to release. Also, MAXLife was critical in ensuring that the Dynamics AX GXP functions were implemented with the appropriate 21 CFR Part 11 compliance requirements such as electronic records with electronics signatures and audit trail.

How has Merit Solutions’ knowledge of the pharmaceutical industry helped you? 
Merit Solutions immediately understood the rigorous and complex requirements of the pharmaceutical industry as a regulated industry. With specific knowledge of process manufacturing as well as lab functions that are supported with inventory management and finance functions, Merit Solutions exhibited a full life cycle breadth of knowledge and experience. It was especially important for us, because being a company with manual processes, we were able to leverage Merit Solutions best practices experience. Additionally, because of limited in-house resources, Merit also was critical for staff augmentation as we implemented AX with MAXLife extensions.

What do you like about working with Merit Solutions? Would you recommend Merit Solutions to other Life Sciences companies? 
Though Merit’s life sciences experience was invaluable, the thing I like best is the integrity and resourcefulness of their consulting and development staff. They don’t just get the job done, they get it done on time and provide quality deliverables which is critical to ensure efficiency, effectiveness, and compliance. They don’t give up and they always make things right. I trust them implicitly and I look forward to our continuing relationship.

How has Merit Solutions improved your day-to-day operations?
We have automated many critical processes from document management to inventory management to lab life cycle management using MAXLife. Our employees are using the systems and have seen efficiency improvements as well as a confidence that we are producing compliant GxP deliverables. Our users are looking for more out of the systems now… Merit has helped us leverage the system even though all processes aren’t yet automated. We still have manufacturing, EAM, and quality systems left to implement as we move toward our technology strategy of a fully integrated Life Sciences ERP solution using Microsoft Dynamics AX as the foundation. Merit is an integral partner to our vision and I look forward to our continuing partnership.