PDL BioPharma Selects InnoCielo Meridian Enterprise with DataCore FDA Module


InnoCielo Meridian Enterprise for the Pharmaceutical Industry Data Sheet

Management Software Tracks More Than Details Article




Organizations in the pharmaceutical, biotech, and medical device industries are continually looking for innovative ways to bring new products to market faster. It is critical to maximize market success and lower product liabilities by reducing the risk through validation and maintaining compliance with government regulations. There are specific regulations that guide them in how to present, manage and store information, yet the implementation of these guidelines needs to fit with their individual business requirements.

DataCore Technology provides a number of solutions to fit the data management needs of pharmaceutical organizations, including Asset Information Management, Engineering Drawing Management, and Collaborative Project Management, designed to further enhance the value of your data to your business. Our solutions provide your organization with the ability to:

  • Reduce errors and omissions by ensuring the entire team has access to the latest plans and documents.

  • Improve quality throughout the organization by enabling compliance with U.S. Food and Drug Administration (FDA) regulations such as 21 CFR Part 11 and current good manufacturing practices (cGMP).

  • Increase profitability by bringing new products to market faster and reducing operating costs.

  • Enhance, automate and streamline collaboration throughout the organization by centralizing documentation.

DataCore has significant experience with implementing EDM systems in compliance with 21 CFR Part 11 and other FDA regulations. We have made important investments in ourselves to ensure the high quality and reliability of our services and software products is steadily managed. We have developed and continuously improve upon our Quality Management System and Project Delivery Methodology to ensure we implement systems according to current best practices, such as PMI and GAMP 4. We have also established a training program for new and current employees to maintain industry standard knowledge and continue to grow professionally.