Change Management Posts

Document and Change Management: These Siblings Play Well Together

Document and Change Management: These Siblings Play Well Together

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

This is the story of a beautiful family – Mr. & Mrs. Quality Management and their two children, Document Management and Change Management. Unlike many siblings that squabble daily, the Quality family kids play very well together. Their favorite playground is in the Life Sciences where they frequently collaborate to show off their teamwork and agility.

In that arena, the siblings do sometimes demonstrate distinctive personality traits as well. For instance, Document can be overwhelming, and at times, sloppy and out of control; Change is a constant force and can be difficult at times, but prefers to be in control. In those instances, they need to support each other. There’s no denying their relationship, and that they are, in fact, better together. (more…)

Resources for FDA Compliant Change Management

Resources for FDA Compliant Change Management

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
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Like the corrective action process, the change management process is a central part of your quality management system. Change is difficult to manage because it touches every area of your business (including suppliers) because it is constant, and because the process to manage it needs to be compliance-driven. If you already have a change management process in place, here are some resources to help you understand areas where your process can be more harmonized, compliant, and efficient.

Tell the whole story about each change.

This Q&A on FDA compliant change management provides insight into better managing impact assessment and documentation of a change. These areas are typically weak in most change management processes. The article points out that change documentation is often weak or incomplete because there is an internal assumption that “everyone knows what is going on.” When an auditor or other third party later reviews the change, the record seems incomplete because it doesn’t tell the full story. This can make the process seem less thorough or compliant than it actually is.
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7 Challenges of Managing Change (and How to Deal with Them)

7 Challenges of Managing Change (and How to Deal with Them)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Only so much fits into a 40-hour work week. Pressing deadlines, critical projects, and a growing list of priorities can make it difficult to complete everything that needs to get done. Introducing changes adds new layers of complexity to the mix.

But fear not, managing change throughout your organization does not need to be stressful. Having the right processes and tools can help. Let’s take a look at some of the top challenges and how to beat them. (more…)

How Change Management and Continuous Improvement Work Together

How Change Management and Continuous Improvement Work Together

Massimo Franza, Senior Director of Software Development, Pilgrim Quality Solutions

As my colleague Kevin Lee says in his blog, The Pursuit of Zero Waste: Continuous Improvement to Drive Quality:

The Pursuit of Zero Waste requires that an organization continuously improves its current products, processes, and people involved in making the perfect device, the perfect item or the perfect process to yield zero waste.

So he really talks about how continuous improvement is the key to remain successful and to keep your organization growing.

In today’s post, we’ll discuss the relationship between change management and continuous improvement. (more…)

Get with the (Management) Program… for a Change

Get with the (Management) Program… for a Change

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions

Social networks, outsourcing, mobile apps, expiring patents, mergers and acquisitions, are but a few landmarks in the last 10 years that have changed the way business is conducted forever.  If nothing else, industries have acknowledged that they must embrace change to remain competitive and protect market share.  As such, regulated industries such as life sciences, must adopt a proactive and systematic method to integrate new technologies and efficiencies while preserving the quality, safety and efficacy of their products and services. (more…)

Five Key Essentials for a Good Electronic Document Management System

Organizations need to accommodate continuous improvement activities, daily operations and change that correspond to document content – administering all these documents, making it accessible and keeping it current. Today’s regulated companies must track and manage all documents from different departments, plant locations, customers, vendors and regulatory agencies. To be competitive, a firm must automate its handling of documents with an effective electronic document management system (EDMS). EDMS is a set of products and services that lets users electronically store, locate, retrieve, share and track documents. (more…)

The FDA Devotes Almost Half of its Staff to Product Regulation – Shouldn’t They Eat Their Own Dog Food?

Compliance and Quality management is crucial issue for almost any business, large or small. No matter what medical product your company manufactures or services, it’s a virtual certainty that you are beholden to an array of different regulations, both internal and from the FDA such as cGMP quality systems. Ensuring that your company remains in compliance with these regulations and proving the quality and safety of products and services at all times is something that can’t be left to chance. (more…)