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Compliance In Focus
Posted by Holly Whitta on Tue, Sep 27, 2016

Organization: The Master Key to Compliance

While good organizational skills may present a challenge to many of us, allowing disorder toOrganization_-_The_Master_Key_to_Compliance.jpg follow us to work is simply a recipe for disaster. Not only can disorganization create for a hectic day, it can also lead to larger problems with industry compliance standards and FDA approvals. Whether your company is involved in drug trials or device studies, poor organization can leave your site more vulnerable to non-compliance if risk-based monitoring is used. It can also create an unpleasant environment during an FDA audit if there are issues with a Sponsor or site’s compliance with ALCOA (attributable, legible, contemporaneous, original, and accurate) guidelines. (Please refer to our ALCOA infographic for more information.)

On the other hand, great organizational skills may help your facility avoid an FDA auditor issuing a Form 483 or warning letter, if documentation is complete and accurate. Being well-organized can aid in compliance with the Guidelines for Good Clinical Practice (GCP) for both The World Health Organization (WHO) and The International Conference on Harmonization (ICH). Being systematic and detailed can lead to the assurance of data integrity, the ultimate protection of subjects, and proper tracking of essential documentation. (More information on applying GCP can be found in IMARC’s whitepaper here.)

Knowing how to begin the task of reorganization can be tricky for many. However, the answer begins within the same compliance guidelines that sites and Sponsors strive to meet. Great organization begins with having a well-designed plan, sticking to that plan, and selecting the proper tools and templates to carry out the task at hand.

What methods do YOU use to maintain order within your workplace? Do you have specific tools or templates that are used to assist with maintaining good documentation practices?

Good Clinical Practice

 

photo credit: Sarah Ross photography IMG_9648 via photopin (license)

Topics: ALCOA, Compliance, Organization

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