compliance

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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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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20
Apr

Planning Ahead for Compliance

There is so much to consider during an ERP implementation, isn’t compliance something that can be attacked once everything else is in place? Compliance is a combination of people, processes, and software. Since these same components are part of a successful ERP implementation, it just makes sense to consider both at the same time. A good implementation focuses on more than just installing hardware and software; it considers how that software will complement the way things get done. And keeping track of how things get done (and making sure these processes meet internal and external expectations) is the dominion of compliance.

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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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17
Feb

Green Validation Webinar: Automating the Validation Process

Managing validation document lifecycles and deliverables can be error-prone and time-consuming. Which leads to the question: "Can paperless validation be a reality?"

Join us for our Green Validation Webinar on Tuesday, February 24th, at 12:00pm Eastern (9:00am Pacific) as Valarie King-Bailey, CEO of OnShore Technology Group, discusses effectively managing validation processes and documentation in a consistent and green manner.

This session will cover the following topics regarding ERP validation:

  • Initiating the validation activities early in an ERP project.
  • Eliminating paper documentation and slow approval processes.
  • Reducing time to completion by 50%.

Learn how to ensure compliance, streamline validation, and reduce costs by registering now for this webinar!

And then take a look at the other upcoming sessions we have in our Mastering Compliance and Innovation Life Sciences Webinar Series

26
Jan

What Keeps You Up at Night? 2014 in Review for Medical Device Companies

Quality compliance is never a static concern. With changes in programs and new guidance documents it may feel like trying to hit a moving target. During online discussions, many device manufacturers indicated that their areas of biggest concern were inspections, followed by product recalls, warning letters, UDI implementation and CAPA. Clearly, no one is alone in their concerns.

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20
Jan

The Power and Flexibility of Dynamics AX in Compliance

Everyone knows that an organization has reporting requirements within their accounting departments, but an organization should think beyond financials and recognize that compliance is relevant to so much more.

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6
Jan

When it Becomes Criminal

When the FDA warns of further enforcement, it is not just an attempt to intimidate. There are teeth behind this procedure and companies need to stand up and take notice. Ignoring or excessively delaying a response will not make it go away, the ramifications will only increase.

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25
Nov

Device Design Transfer – A Smooth Hand-off

Getting a new product into the customers hands as quickly as possible is critical to medical device manufacturers. Perhaps during the rush to hand off a product to the manufacturing floor, corners are cut. The end result can be manufacturing delays that prevent the product from going out the door – or even defective product reaching the customer.

Paying attention to the details up-front can save time in the long run. Resolving issues early in the process lends itself to a seamless transfer in house or to a contract manufacturer.

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24
Oct

Life Sciences and Microsoft Dynamics AX – Approaches for Meeting Your Regulatory Requirements

If you are a Microsoft Dynamics AX Life Sciences company attending AXUG Summit today, don’t miss out on the session being led by MAXLife client Donna Lenning, IT Director of Osmotica Pharmaceuticals, as she discusses "Life Sciences and Microsoft Dynamics AX – Approaches for Meeting Your Regulatory Requirements". 

More and more companies in the life sciences industry are running Microsoft Dynamics AX. In this session learn more about the various methods and approaches for setting up and configuring Microsoft Dynamics AX to meet the regulatory and special requirements the life science industry requires. Life Science SIG members are encouraged to attend this session.

The session takes place today, Thursday October 24th, from 2:30-3:30pm in room CC-31/32.