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Jun 25, 2015

4 Reasons Why Document Review is Crucial to Compliance


When was the last time you reviewed 
your quality documents?
by Cindy Fazzi
Editor, MasterControl Insider

When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

“For organizations using a paper-based or hybrid system, a common problem is lack of document review,” said Jackson. “They have internal policies that require them to review their SOPs, work instructions, and other critical quality documents on a regular basis, but they fail to track them down. When that happens, they are violating their own policies.”

Jackson works closely with regulated companies that comply with FDA and other regulations, as well as ISO and other international standards. He said switching from a manual process to an electronic system such as MasterControl is a major initiative, which explains why many organizations neglect to review essential documents during the transition.

4 Reasons Why You Need Document Review

“During revision, people are shocked to discover that they haven’t reviewed an important document in so many years. A regular review will help you in your revision process because you will know immediately if something needs to be revised. Don’t wait for something to happen that forces you to revise your document. By reviewing regularly, you become more proactive about change,” said Jackson.
This article is related to the Whitepaper: Automating Document Control Processes.To get the full details, please download your free copy.

If your company is regulated and you can’t remember the last time your quality documents were reviewed, Jackson said these are the reasons why it’s time to do it sooner than later:
  • To update processes and instructions that have changed.
  • To ensure your employees are using the latest documents and following accurate instructions and procedures.
  • To boost your preparedness for audits and inspections.
  • To comply with ISO, GxP, and other standards and regulations.

The frequency of document review depends on how often a document changes and how complex and important it is. Processes that change constantly might not need a formal review date because each update already calls for a review.

Benefits of “Built-In” Document Review

Companies that use a paper-based or hybrid document management system typically use a spreadsheet to track down documents. It’s not foolproof and it’s one of the reasons document review falls through the cracks.

An electronic system will automate basic tasks such as scheduling the reviews, sending out reminders, and distribution of documents. Jackson said if you are looking to automate your manual system, choose a software solution with built-in document review.

For example, MasterControl Documents2 gives users an option to add a review date to a document. If an SOP is scheduled for review on Aug. 1 per policy, the system will notify the stakeholders in advance to make sure the document is reviewed before then. Users can set the amount of time they need—30 or even 60 days in advance —to review and revise the document prior to the review date.

Jackson cited the following benefits of an automated document management system in enforcing a company’s document review policy:

  • Ability to add a review date to important documents that impact compliance.
  • Task assignment, notification, and escalation are automated. There is no need to “hunt down” people, so inviting non-quality personnel to participate in document review will be easier.
  • Ability to designate a role instead of a user for the task of reviewing a document. Even when employees move on to different departments and positions, or if they leave the company altogether, the role of document reviewer will stay, which means the right person will always get notified and the task will not be forgotten.
  • The document review process will be visible to stakeholders. Look for a system with robust analytics and reporting function so you can generate a report to see which documents are due for review at a certain time (in 60 days, 90 days, etc.) and you can then spread out your future review dates.

Good documentation is part and parcel of GxP standards, which require accuracy of quality procedures and documents. “Reviewing these documents regularly should be a part of your compliance efforts,” said Jackson.




Cindy Fazzi is the editor of MasterControl Insider, a monthly publication for MasterControl users. She writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.


References:
1Marty Jackson, who joined MasterControl in 2011, is originally from Ann Arbor, Michigan, area. He’s a former Deloitte consultant with over 10 years of experience providing consulting services to businesses and government agencies, including 19 of Fortune’s Top 500 companies.
2To learn more about MasterControl Documents, go to: http://www.mastercontrol.com/document-control-software/?lne=nold&nlc=doccon






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White Paper: Automating Document Control Processes
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Product Data Sheet: MasterControl Collaboration™
White Paper: MasterControl: What's the Return on Investment?