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‘Oh Crap,’ Was That Today? Keeping on top of regulatory document management

by Terry Bird

Anyone who works with regulatory documentation knows it can be difficult to stay on top of all the associated documents, requirements and deadlines. Let one aspect of the process slip your mind and you’ll feel like you are watching the ark sail away as the water rises around you. Failing to maintain proper regulatory documentation can end up costing your organization both money and your good reputation, making it more difficult to acquire new business and funding.

The procedures for managing regulatory documents can pose organizational problems. Most organizations track and complete these forms on paper. The forms need to be approved by multiple people, copied and stored in numerous places, which is made even more complicated when there are multiple locations in a network that need to maintain the same information. This leads to dozens of chances to miss a deadline, misplace a form or end up with incorrect information being submitted.

An opportunity to improve efficiency and reduce cost

Recently, a major Minnesota healthcare provider realized the value of changing their process for lab certification and accreditation management. With 190 labs running over 2 million tests per year, the provider’s process of manually tracking certificate completion, maintenance and expiration dates in a spreadsheet was challenging.

Collaborating with VACAVA Inc, a custom solution provider, they designed and implemented a software application which simplifies data collection, management and access. The cloud-based implementation enables remote data entry in a real-time sharing environment and introduces features like certification renewal notifications, compliance reports, profile management, certificate archiving and automated certification/accreditation form population. With the help of this new solution, the organization has increased its efficiency and reduced its costs.

Reducing the complexity and cost of clinical trial regulatory document management

A major cancer center also recognized the opportunity to dramatically reduce management complexity and cost by transforming their clinical trial regulatory document process.  This comprehensive cancer center offers its patients opportunities to participate in more than 500 clinical trials at multiple locations. They simplified their clinical trial regulatory documents collection, management and access by collaborating with VACAVA, Inc. to design and implement an affordable custom application specific to their needs.

Paper documentation has been replaced with easy-to-create online forms, a single source of online information has eliminated confusion caused by multiple paper versions, and all signatures are obtained via electronic signature. The cloud implementation enables remote review of regulatory documents to ease the review process performed by monitors and auditors. This new application has enabled the institution to significantly increase efficiency and quality, while reducing the cost of its regulatory document management process.

VACAVA. Inc.

VACAVA’s mission is to deliver high-quality, affordable custom applications that allow companies to reengineer their existing processes and operate more efficiently and effectively. VACAVA’s solutions are tailored exactly to the needs of the organization, allowing us to work with companies of all sizes, from fledgling ventures to Fortune 500 companies.

Learn how VACAVA can help your organization. Contact me today.