Regulatory Document Management Strategies

Precise regulatory documentation is an imperative in the healthcare industry. The sheer amount of paperwork and detailed tracking required for regulatory compliance can be daunting and costly. A well thought out automated document strategy can ease minds, facilitate audits and make a surprising difference in the efficiency of your operation.

Regulatory documentation often comes in paper forms that are copied and placed in numerous locations, approved by multiple individuals, and audited manually. Regulatory data may be collected and accessed via spreadsheets and IT applications, then manually, consolidated to complete tasks and make management decisions.

The problem with these methods is their inefficiency and the large time investment they require from employees in order to keep records up to date. Read how three healthcare organizations automate their regulatory document management processes to increase operational efficiency, reduce cost and improve quality.

Reducing the complexity and cost of clinical trial regulatory document management

A major cancer center 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 multitple 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 research regulatory document management process.

Preparing for exponential growth in regenerative medicine

A manufacture and distributor of stem cell culture media recognized the need to rapidly scale production as their pharmaceutical clients were completing clinic trials and preparing for commercial use.

In the highly regulated pharmaceutical industry, auditability and trackability of every critical material is imperative. Patient and product safety is a matter of utmost importance. Therefore manufactures, must implement audit and tracking processes that document critical materials from supplier, through manufacturing, to the end user. The custom application developed by VACAVA, Inc. supports the collection, retention, management and access of this supplier's, manufacturing and end user data supporting Good Manufacturing Process (GMP), ISO, and CFR regulations.

By implementing a cloud-based document solution from VACAVA, this manufacture now has an infrastructure that will enable them to rapidly scale efficiently and productively, without adding exponential staff or technology expense.

Improving the efficiency and cost of Lab Certification and Accreditation Management

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, 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.

These are three different Healthcare teams who embarked on similar strategies to improve their efficiency and costs through smarter regulatory document management.

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


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.

Tags: Regulatory Document ManagementRegulatory Binder ManagementLab Certification ManagementVACAVAcustomsoftware