DataCore FDA Module

The DataCore FDA Module is an essential component of a comprehensive document management solution for pharmaceutical organizations with the need to manage GMP engineering documentation. DataCore’s FDA Module was developed to work within InnoCielo Meridian Enterprise, BlueCielo ECM Solutions' flagship document management software. Each aspect of the FDA Module is configurable and integrates seamlessly with InnoCielo Meridian Enterprise to comply with 21 CFR Part 11. The DataCore FDA Module has been installed and validated in numerous pharmaceutical organizations with multiple locations, and is available with validation documentation templates to reduce the cost and effort of validating the system.

• Audit trails
• Electronic signatures
• Workflow
• Life cycle & validation documentation
• Controlled printing
• Enhanced access control
• Bullet-proof security

Contact us to receive a Gap Analysis Report that compares each section of 21 CFR Part 11 and explains the functionality missing in out-of-the-box InnoCielo Meridian Enterprise by itself, but available with the FDA Module add-on.

• Improve compliance effectiveness
• Reduce residual compliance risk
• Reduce time spent searching for information
• Expedite the review process
• Increase profitability by cutting time-to-market for new products and reducing the cost of engineering operations

While DataCore Technology is the exclusive provider of the FDA Module in the United States, we have also formed strategic partnerships with some of the best international BlueCielo ECM Solutions resellers who can provide your organization with the DataCore FDA Module, implementation, and computer systems validation services. 

Click here to find a reseller in your area!