Deacom provides a high-level design document that includes the following: System Build This phase involves the delivery of the system build that will be in place at the time go-live.
DEACOM ERP software provides many tools to assist with the process which includes recording the history of all data conversion loads completed during implementation, outlining base test scripts that can be configured to support the OQ process, and providing Standard Operating Procedure (SOP) functionality to make creating the documents easier.
The FDA requires a specific set of documents as part of the 21 CFR Part 11 validation process and they are listed below.
The documents highlighted in blue are provided by Deacom.
Our ERP software includes the built-in tools necessary to assist you with this process and provide you with the most efficient means of meeting the requirements of 21 CFR Part 11 validation.
The promise of ERP systems is comprehensive and multi-disciplinary control of the entire enterprise - this often translates to unpredictable costs, unforeseen setbacks, and the fleeting "last mile." Our ERP specialists are well versed in the realities of ERP deployment and optimization.