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Quality and Compliance: The Ogres Under the Bridge?

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?"

The 3 D's of Medical Device Documentation

We are surrounded by acronyms. It is a wonder we can communicate at all. To make things more complicated, every industry has its own set of terms. The files defined below may sound similar but are governed by different requirements. They are all connected like the cars of a train. It is important to understand the expectations for each file in order to maintain compliance. Poor design controls can lead to product issues and a poorly compiled DHR may indicate a lack of evidence that the product was manufactured appropriately. Continue reading "The 3 D's of Medical Device Documentation"

Change will do you good

Change is inevitable. The ability to control change is the challenge. It is the most important part of a company’s quality management system and is critical to ensure product safety and efficacy. Companies need to be able to respond to change quickly while maintaining compliance. Although it may seem like a daunting task, it is important to create a culture where the process of change is all about improving quality.

Continue reading "Change will do you good"

Customers Are Complaining - Make Sure You Are Listening

One of the most common reasons for FDA warning letters is for deficiencies in complaint handling. They typically fall into the following areas:

  • Inadequate procedures or failing to follow procedures to collect, document and interpret complaints
  • Inadequate timeliness of closure
  • Inadequate connection of complaints to reportable requirements

A complaint is any customer dissatisfaction with quality or performance and may include packaging or labeling.

Given that broad definition, it may be a difficult task to have processes in place to handle complaints as it becomes hard to sort through and give each an appropriate evaluation and to further escalate and take action on the serious ones. Products that pose a significant risk to the user are more regulated and it is expected that they are captured and investigated efficiently.

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Life Sciences Supply Chain Confidence

Manufacturing is generally a global endeavor. Supply chains cross borders creating a convoluted matrix of primary and third party suppliers. This makes knowing what you’re really getting more challenging. Comprehensive supplier control procedures are a must. The FDA holds the manufacturer responsible for the integrity of the materials or services that are outsourced. A review of warning letters clearly makes the case to implement a robust supplier program. Continue reading "Life Sciences Supply Chain Confidence"

Webinar Recording: Integrating Microsoft Dynamics AX into a "Hybrid" QMS Environment

Merit Solutions was happy to host the first webinar for AXUG's Life Sciences Special Interest Group. 

In many Life Sciences organizations, functions are spread across multiple business systems. For example, sales teams work in Salesforce.com, logistics works in Microsoft Dynamics AX, and quality tracks their documents in an external Quality Management or Document system.

Join us to learn about the pitfalls of this approach, and what the ideal integration strategies are for handling data that has multiple touch points, such as:

  • Items
  • Customers
  • And how these relate to Quality documents like ECOs, CAPAs, NCRs, and Complaint tracking

If you are in the Life Sciences industry and you missed this meeting, you missed a great session! No worries though because we recorded it for you so that you are able to view and not miss out on the great knowledge that was shared!

Download the on-demand webinar: Integrating Microsoft Dynamics AX into a "Hybrid" QMS Environment.

Microsoft Dynamics AX Validation Webinar Recording

What a great meeting hosted by Valarie King-Bailey on Validating Dynamics AX - What you Need to Know!

This meeting focused on how software validation is a mandatory requirement for highly regulated companies - especially life sciences. As life sciences companies adapt Microsoft Dynamics AX, they must consider how to validate the system to help ensure sustained compliance.

The goal of this webinar was to introduce 21st century validation techniques and discuss practical strategies for the validation of Microsoft Dynamics AX.

If you are in the Life Sciences industry and you missed this meeting, you missed a great session! No worries though because we recorded it for you so that you are able to view and not miss out on the great knowledge that was shared!

Register now to view the webinar from Merit Solutions' partner - Valarie King-Bailey and OnShore Technology Group.

Audit Readiness - A 24/7 Culture

The notification everyone dreads has come. You are being audited. The organization kicks in high gear “to get ready”. They believe they are being proactive because the activities are occurring before the audit. In actuality this is reactive behavior brought about by the notification.

The quality culture should be robust enough that any time an inspector comes in you are ready. It should be a mindset for everyday and extend to the entire staff throughout the facility not only in the quality functions.

Continue reading "Audit Readiness - A 24/7 Culture"

Are You Still Doing What You Say You Are Doing?

A very common audit observation is not following procedures. 23% of quality related warning letters issued by the FDA in 2013 were for document controls. The lion’s share of these issues involved the use of documents that do not follow the process. An auditor may notice a gap while reviewing document controls, reviewing executed records, during direct observation of your process or through questioning of operators. They may also probe multiple operators to establish consistency.

Some managers may have a false sense of confidence in thinking that “We’re O.K. We have a procedure for that.” Yes you can certainly be cited for having no procedure at all. But you have to look at the adequacy of the procedures to the purpose and scope. The CFR requirements are specific. Documents should be clear and easy to follow. Changes have to be documented, reviewed and approved. Communication of a change and evidence of training must be documented.

Continue reading "Are You Still Doing What You Say You Are Doing?"

Osmotica Pharmaceutical Customer Spotlight

We recently had the opportunity to speak with Donna Lenning (IT Director) and Kelly Moore (QA Documentation Manager) from Osmotica Pharmaceutical, a global drug delivery company based in the US.

Donna and Kelly were gracious enough to discuss their experiences working with Merit Solutions, the benefits they have received from MAXLife's Pharmaceutical ERP for Microsoft Dynamics AX functionality, along with the Quality Document Management and Training and Certification Management MAXLife SharePoint applications.

We hope you enjoy their feedback!