Ensuring Compliance with SciCord’s Pharmaceutical Validation Service

Summary

SciCord Solution is provided as a Commercial off-the-shelf software or COTS.  SciCord provides a complete package documenting control of the software product.  Additionally, documentation and testing are required to verify the software product meets the organization requirements within the target environment with appropriate control of people, hardware, and process.  SciCord’s pharmaceutical validation Service is intended to provide the required customer specific documentation.

Goal

Computer system validation of a COTS solution in the pharmaceutical industry must ensure an acceptable degree of documented evidence establishing confidence in the consistency, accuracy, and reliability against predetermined specifications.

The SciCord Validation Service goal is to ensure both technical and procedural controls are implemented for compliance with good documentation practices for electronic data generated by the system

Service Design

A Typical model for computerized systems validation is presented in the image below:

The Software as a Service (SaaS) delivery model of SciCord greatly simplifies the customer specific validation activities.  Hardware in the SaaS delivery model is entirely the responsibility of the vendor, thereby removing a major complicating factor from the customer validation task list.For COTS solutions, much of the documentation/testing in the model above should be supplied by the vendor.  The customer specific documentation includes User Requirements and Performance Qualification.

Deliverables