Government regulations are becoming more prevalent and we can only expect this trend to continue. Just because they don’t touch your business today doesn’t mean they won’t in the near future. Compliance isn’t just for the finance folks anymore. Which is why it’s important to consider compliance issues while selecting an ERP software solution.Continue reading "Compliance: Robust Reporting is Key"
Entries tagged as compliance
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.
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.Continue reading "What Keeps You Up at Night? 2014 in Review for Medical Device Companies"
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.Continue reading "The Power and Flexibility of Dynamics AX in Compliance"
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.Continue reading "When it Becomes Criminal"
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.Continue reading "Device Design Transfer - A Smooth Hand-off"
The bridge from product inception and or production to the customer’s hands may seem like an amicable journey. The plan is followed and milestones attained. Then QA jumps out and growls that the product can’t be released due to a potential quality issue. The result: deadlines not met, revenue not realized and workplace harmony is destroyed. Sound familiar? Well you aren’t alone.
A 2014 survey of device manufactures conducted by Compliance-Alliance found that 27% of respondents categorized QA as a “necessary evil, a deterrent to revenue or a policeman who always says no.”Continue reading "Quality and Compliance: The Ogres Under the Bridge?"
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.
If you're like a lot of the Executives we've been talking to recently, some of your main goals and objectives for 2014 include:
- Driving growth by increasing margins, expanding into new geographies, and speeding innovation and time-to-market.
- Improving operational effectiveness by standardizing processes, increasing visibility, driving efficiency.
- Improving decision making with better access to real-time data and key performance indicators.
- Future-proofing IT architecture by meeting the profoundly more demanding IT trends of businesses today:
- Supporting BYOD (Bring your own device)
- Exploiting Big Data
- Connecting via Social Media
- Utilizing the Internet "Store"
- Mitigating risk and maintaining compliance with improved visibility, control, and security.
Do these sound familiar?
When Trading Technologies International, Inc. found themselves facing similar objectives, they decided they needed to integrate their company with a global ERP solution and streamline and standardize their business processes. Read more about how they did it - and the benefits they have received since undergoing their business transformation: Trading Technologies Implements Microsoft Dynamics AX to Optimize Processes, Extend Organizational Insight, Improve Decision Making, and Transform Their Business.
The Life Sciences industry is often considered a leader when it comes to the utilization of new, innovative technology to drive major advancements in R&D. However, we have found that when it comes to inventory, manufacturing, and supply chain management business processes – many Life Sciences companies still find them-selves buried in paper or using 20 year old technology.
By maintaining the status quo, these companies are ignoring the significant cost savings, efficiencies, and competitive advantages that new, innovative Life Sciences ERP systems can provide.
This white paper will look at some of the key feature requirements enterprise Life Sciences companies should look consider when evaluating new Quality and Compliance ERP software. It will also identify how today’s industry leaders are using Life Sciences ERP Software like MAXLife to achieve compliance, eliminate costly paperwork errors, reduce operating costs, speed up information distribution and collaboration, and enable strategies for improving product quality and process efficiency.
Read the white paper: Managing Quality and Compliance: Life Sciences ERP