ADVANCED SOLUTIONS FOR ECTD ASSEMBLY & PUBLISHING
Global life sciences companies are increasingly adopting the eCTD as the preferred format for global dossiers. The International Conference on Harmonization (ICH) has established an acceptable format for the electronic Common Technical Document (eCTD) to facilitate the delivery of dossiers to global agencies in a uniform manner. The U.S. has indicated that the eCTD is their preferred format beginning January 1, 2008.
To develop a fully electronic dossier based on the eCTD format requires a comprehensive strategy and integrated technologies to ensure success. These technologies include:
- Enterprise Content Management
- Quality Assurance
- Input/Capture Technologies
- Electronic Publishing
- Transformation
- Storage Technologies
- Integrated Messaging
Infotehna’s eCTDExpert™ - The RIGHT Choice
eCTDExpert™ is a comprehensive solution that leverages Infotehna’s own compliance process control engine coupled with EMC/Documentum’s flagship content management technology. The solution delivers regulatory document control in accordance with cGMP and GAMP guidelines. In addition to its comprehensive document lifecycle workflow, cGMP change control, security model, audit trails, digital/electronic signature capability, version control, eCTDExpert™ includes an integrated input/capture and publishing capability for document rendering, publishing, and eCTD XML generation. The system is fully compliant 21 CFR Part 11 guidelines for closed systems and is validation ready. eCTDExpert™ delivers a total solution for regulatory affairs organizations.
Rapid Deployment and On Demand Technical Support
In support of eCTDExpert™ Infotehna provides comprehensive on demand services and technical support to ensure rapid deployment and system adoption. All Infotehna life sciences solutions are deployed in validated systems environments, thus we offer validation (IQ/OQ/PQ) protocols to support validation efforts.
To facilitate rapid deployment, Infotehna’s technical team stands ready to deliver tactical project management services, training, and migration services for a turnkey approach. Stop wasting time and money on “solutions” that require expensive customization and integration. Infotehna’s all-in-one eCTDExpert™ is designed to accelerate your return on investment and implementation. If your objective is compliance and you seek a cost effective solution for quality, R&D, regulatory, and marketing, look no further than Infotehna’s eCTDExpert™.