Document 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…)

Get Your Documents Under Control

Get Your Documents Under Control

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Do people ever tell you that you’re a control freak? That’s not typically a compliment, unless you work in the Quality or Compliance departments at your company. Then it’s an aspiration.

A robust Document Control process lies at the heart of a Quality Management system. Nearly every element of auditing and compliance is verified by examining documented evidence. That’s the FDA inspectors’ bread and butter, so to stay compliant, you need to keep your organization’s documents fresh and handy. (more…)

Document Management in the Quality Fold: What You Should Know

Document Management in the Quality Fold: What You Should Know

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

If you work in the Quality arena, you probably know that the effectiveness of a Quality Management System (QMS) relies extensively upon enterprise-wide collaboration and begins with a solid process for managing important documents, like standard operating procedures. But as rapidly as business and its processes evolve these days, many organizations struggle to stay current in a sea of change. So it’s not surprising that document management remains at the very top of quality management processes being automated within the highly regulated Life Sciences space. (more…)

Pushing Paper (Or Not): Cloud-based Document Management Saves Time, Reduces Risk

Pushing Paper (Or Not): Cloud-based Document Management Saves Time, Reduces Risk

Mark Crawford

Sometimes the most important step in a successful product launch is knowing where the documents are—getting delayed by not being able to find the documents the FDA insists on seeing (or worse, having to start over) is a major drag.  The same is true when it comes time for an FDA audit. (more…)

Time For SaaS?

Time For SaaS?

Michael Reynolds

Outsourced Enterprise Compliance and Quality Management  — application and data management in the form of Software as a Service (SaaS) — is a partnership needed more  today than ever, particularly in the increasingly complex regulatory environment that Pharma, Biotech and Medical Device companies find themselves. (more…)

Do You Know Where Your Documents Are?

Mark Crawford

According to the FDA, six words not to utter on FDA inspection day are: “Now, where is that darn document?” (It’s nice the FDA has a sense of humor, at least on paper).

Kidding aside, this is a big-enough issue that the FDA recently offered a seminar to alleviate problems such as:

  • Unscanned paper documents
  • Confusing naming conventions
  • E-mails as documentation
  • Non-functional or non-existent SOPs
  • Missing documents

(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…)