Medical Device

1
Sep

Managing Compliance Risk in Medical Device Manufacturing

The medical device manufacturer that had a spectacular compliance failure probably made the headlines. Their story will be noted in university classes around the world for years to come. Let’s look at another outcome.

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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.

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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.

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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.

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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.

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28
Dec

Life Sciences Videos

In order to sustain profitable growth, today’s Life Sciences companies must redefine the way value is delivered, reduce costs and eliminate waste, and enhance quality and safety.

Fill out the form below for access to the following Life Sciences Videos:

  • Life Sciences Webinar: Electronic Batch Records
  • Life Sciences Webinar: Business Process Improvements
  • Integrating Dynamics AX into a Hybrid QMS Environment

  • Green Validation: Automating The Validation Process

26
May

New White Paper: Using ERP to Prepare for Commercialization

New products in the Life Sciences industry fail to win a significant spot in the market at an alarming rate. And since the costs of bringing a product to market are extremely high – the risk of any missteps can be devastating. Therefore, it makes sense for biotech, pharma, and medical device companies to use every tool at their disposal to ensure they are as prepared as possible. Unfortunately, many companies overlook one of the most versatile tools available to them – their ERP solution.

If you are an early stage and rapidly growing Life Sciences organizations, download this free white paper to learn how Life Sciences ERP systems can help you:

  • Increase corporate value
  • Mitigate risk
  • Ensure compliance
  • Orchestrate your supply chain
  • Setup quality assurance and CAPA processes
  • Manage customer complaints and returns
  • Maintain a validated and qualified environment

Download the white paper now: Using ERP to Prepare for Commercialization.

18
Apr

New Life Sciences ERP White Paper

It goes without saying that every business that intends to grow needs an ERP system that provides a framework for business processes and insight into costs, results and performance. For companies in some industries, almost any ERP system will probably work fine. But because of the highly regulated nature of their industry, Life Sciences companies have special requirements they need to consider when selecting an ERP system.

Too often, Life Sciences companies don’t realize that not all ERP systems are the same. Companies in this industry need an ERP solution that meets all their unique business needs and that can also help them to reduce the risk of non-compliance with government regulations. At a minimum, an ERP system in Life Sciences should have strong support for crucial industry specific needs that allow the company to meet its regulatory compliance obligation without adding burdensome manual processes that add unnecessary costs.

In this white paper, we explore some of the common requirements of ERP for biotech, medical device, pharmaceutical, and other life sciences organizations- including Track and Trace, Electronic Signatures, Effectivity Dates, Quality Management Systems, Document Management, and ERP Validation.

Access the free white paper today: ERP in Life Sciences.

26
Feb

Free Electronic Batch Records Demo Webinar – March 8th

Register now and join Merit Solutions and Ultra Consultants on Tuesday, March 8 at 1:00pm CST for a free Electronic Batch Records demo webinar.

During this webinar we will discuss:

  • Introduction to Electronic Batch Records (and Device History Records)
  • Benefits of Electronic Batch Records systems
  • And an Electronic Batch Record demo of functionality in MAXLife.

We hope you can join us for this free webinar!

Electronic Batch Records
Tuesday, March 8th, 2016
1:00pm – 2:00pm CST
Presented by: Merit Solutions and Ultra Consultants

Register Now

10
Feb

MAXLife Video – Microsoft Dynamics AX for Pharmaceutical, Medical Device, and Biotech Organizations

Why should pharmaceutical, medical device, or Biotech organizations considering new enterprise ERP systems include MAXLife for Microsoft Dynamics AX in their shortlist of potential solutions?

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