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.

If you’re somewhat dysfunctional when it comes to data retrieval and upkeep, you could find yourself out of date and out of compliance. If your document process is out of control, any of these deficiencies could contribute to your company’s regulatory undoing:

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

Spring (Cleaning) is in the Air

So what are the FDA’s expectations when it comes to document control? There are quite a few, and they’re all dependent on running a tight, organized ship. For instance:

  1. The FDA wants only current and approved documents to be accessible to employees.
  1. The FDA expects documents to be reviewed on a regular basis (annual or biannual) to make sure they are still relevant to current business processes (effectiveness review).
  1. New documents or documents being revised should go through a change control workflow to ensure that changes being implemented are valid.
  1. Involved personnel need to be notified when a new document/ SOP is released and adequately trained on each document revision. A training matrix or training history should also be maintained for these staff in order to display training history on a document.
  1. Documents need to be retained for an appropriate length of time, which may vary based on the type of document.

Eliminate the Clutter

From a Quality perspective, to meet the FDA’s expectations, it’s critical to put – then keep – your records house in order. The first step to maintaining control is to take stock of the current status, and then target the deficiencies. Are there approaches to handling critical documents that could use improvement or are there steps to simply eliminate?

There are some common hiccups among Life Sciences companies when it comes to document management, and the most effective way to overcome or eliminate these is through automation. For instance:

Document-initiated training. Updates to a document are the catalyst to notify employees that training is needed; then each employee’s training completion/signoff is tracked automatically. Under a manual system, this becomes more difficult as the number of documents and employees increase when a company grows or introduces new products.

Impact analysis for changes. When using a manual system, it is difficult to understand exactly which documents are affected by a change made to another document.

Document search and retrieval. Locating the necessary records is more difficult in a manual or network system. An electronic document management system provides more ways to organize and search for documents easily. For example, using dashboards and repositories can eliminate searching by showing users the documents they need to work with or that need their attention.

Periodic review of documents. Review of design specs, work instructions, SOPs, forms, etc. cannot be performed effectively in a cluttered, inefficient, or out-of-control handling environment. One has to remember when to review the document for its accuracy and find the document before it expires. Automatic reminders can eliminate oversite.

Efficiency Effects

While these hiccups will trip up most companies, there are exceptions. If a company is passing audits, they may conclude they are doing a good job with a manual document management system. However, it might be worth considering the hidden costs to the organization — lots of non-value added work just to maintain the system.

An electronic document management solution will save time and allow employees to focus on other tasks, instead of following up on pending approvals or training needs, manually updating training records, manually updating the newest document version, manually creating document master lists or training reports, etc.

They may also want to consider their plans for growth. If they are planning to hire a significant number of employees, introduce a new product, or add a new facility, the time needed to manually manage documents will grow very quickly. A manual system that is working now may be too difficult to manage a year from now.

A Fresh Start

An effective Document Control process should consistently achieve all the improvements mentioned above. A robust, automated document management solution will be able to integrate with other solutions and provide access to approved, controlled documents throughout the quality and regulatory system (CAPA, audit, etc.). Ultimately the most significant benefits come in the areas of reduced cycle time for approvals, improved collaboration, more accurate training notifications and reporting, streamlined periodic reviews, and visibility and management of changes. Best of all? All of these tie directly back to the FDA’s inspection agenda, thereby supporting overall compliance and successful Quality audits.


Document Management

5 Minute Overview

Our document control software enables you to create, collaborate, approve, change, and train on documents within a single system. Download this video to learn how Document Management can help your organization.

medical device complaint handling



Sandy Carson

Marketing Communications & Events Manager, Pilgrim Quality Solutions

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