Regulatory Consulting Firm Extends Reach with Online Document Management
Reglera is recognized as one of the largest and fastest growing regulatory consulting and business process outsourcing companies in the world. Since 1999, this Lakewood, CO, company has been helping human tissue and medical device companies navigate the regulatory maze through its expertise and understanding of regulatory and quality systems requirements.
Document Change Control Management is one of the outsourcing services Reglera offers. The Food and Drug Administration (FDA) and other agencies require that documents associated with product design and information be controlled. Examples include design/construction documents, standard operating procedures, employee training records and policies and procedures. The volume of documents a tissue or medical device company must manage is considerable. Companies engage Reglera to provide document control services – thus replacing and/or eliminating the expense and hassle of managing their own internal document control departments.
ImageSilo, an on-demand, web-based document management system, is one of the tools Reglera uses to provide its Document Control Services. The software provides a validated, secure system to index, manage and control all types of documents (i.e. word documents, Excel spreadsheets, CAD drawings, etc.).
An easy-to-use system, ImageSilo allows Reglera administrators and customer companies across the country and around the world to easily locate and organize crucial procedures and quality records 24 hours a day, 7 days a week. Because ImageSilo is web-based, Reglera can service an unlimited number of end users – regardless of their geographic location – without having to incur the expense and hassle of onsite software installations. The system accurately tracks document revisions and provides audit trails to trace when documents have been accessed, updated, etc.
“Image Silo has proven to be a dependable, user friendly and easy way to integrate and extend Reglera’s Electronic Document Change Control Management service to our end user client,” said Tim Anschutz, Vice President of Sales and Marketing at Reglera. Anschutz added, “Offering an ASP option provides clients with a nice entry point for helping keep capital expenditures low while also minimizing IT support for on-going hosting and maintenance activities. Depending on the business scenario, the web option can provide a very attractive and superior ROI.”