Implementation Services
PharmaReady Implementation Services offers the people, processes, technology, and experience to ensure your specific implementation is successful. We have extensive experience in helping to define library structures, reader groups, and all rolls that support our customer’s operational goals.
During your implementation we are 100% focused on the needs of your Life Sciences organization. Our services cover a strategic assessment of your existing infrastructure, professional assessment, and a full product rollout when required.
PharmaReady meets all the regulatory requirements that are pertinent to your needs, including FDA 21 CFR Part 11, and cGMP compliance, International quality standards & regulations, meeting the needs of varying countries and regulatory agencies.
- Project Plan Development: PharmaReady assigns a Project Manager as the central point of contact for the duration of this project. PharmaReady’s Project Manager will work jointly with our customer to develop a comprehensive Project Plan to maximize efficiency and effectiveness of the PharmaReady system roll-out for each customer.
- Implementation Support: PharmaReady provides full implementation support to include, but not limited to, helping to define library structures, reader groups, and roles in a manner that supports our customers’ operational goals and objectives.
- Software Set-up: PharmaReady provides full software configuration and set-up services to ensure that the server along with the PharmaReady and Microsoft software components are fully functional in the customer’s environment.
- IQ/OQ Documentation: A full set of Installation Qualification and Operational Qualification documents are provided with the software licensing fee.
- Document Loading: PharmaReady will load existing MS Office documents into the system from a cross section of our customer organization. PharmaReady will set up the review and approval workflow process and all other relevant document properties for these documents.
- System Training: PharmaReady provides Administrator, Document Management, Reader, and Technical web-based training sessions along with a full complement of training guides.
- Validation Services: PharmaReady will provide Part 11 Validation Services to include executing the Installation Qualification and Operational Qualification documents to ensure a proper PharmaReady implementation and validate that all functions operate as designed.
- Maintenance & Support: Includes web support, unlimited phone and email business day support, and all software upgrades during the term of the Maintenance & Support agreement.
Learn more about the fully integrated, regulatory compliant PharmaReady DMS, eCTD, SPL, and TRMS solutions.
|
|
