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