Validation Services

PharmaReady Application Validation Standard Documentation and Services include modifying per each client’s requirements and executing the Installation Qualification and Operational Qualification documents to ensure a proper PharmaReady implementation and validate that all functions operate as designed.

The documents provided with PharmaReady as a part of our standard validation documentation include:

• Computer System Validation Plan
• Installation Qualification
• Operational Qualification
• IQ & OQ Execution
• Validation Summary Report

Each client is provided our standard validation documents above which are used to ensure the software is installed correctly and allow basic administrative and work flow functions.  Clients have the opportunity to review these Installation Qualification document and the two Operational Qualification documents and may opt to modify the initial baseline documents to accurately test their specific application configuration of the software.  The PharmaReady team then updates the IQ and OQ documents based on the clients’ changes.  Our clients approve the IQ and OQ documents in writing prior to our performing the validation.

After completing the execution of the IQ and OQ documents, we scan the completed documents and all supporting documentation and will mail the original documents with all supporting data to the client and/or any appointed client representative for post execution approval.  Our clients retain the original IQ and OQ documents and all other validation and training related documentation.  Lastly, the client sends us a copy of the post execution approvals and we prepare the formal Validation Summary Report.

For more information on Validation services email us.

Learn more about the fully integrated, regulatory compliant PharmaReady DMS, eCTD, SPL, and TRMS solutions.

• Overview
• Validation Services
• Regulatory Consulting Services
• Implementation Services
• Technical Support
• Education
• eCTD Templates
• PharmaReady Hosting