CIPER Beginner's Guide

What is the CIPER system?

CIPER system is an Internet application designed to support the 21 CFR Part 11 assessment process.

The CIPER service includes, for example, 21 CFR Part 11 assessment questionaire, on-line access of corresponding knowledge base (e.g. FDA Warning Letters), and cooperation of 21 CFR Part 11 experts.

The focus of CIPER is on the electronic record systems in FDA regulated companies. To use the CIPER service, the system to be assessed and the owner company should be registered first in the CIPER system.

Who are the CIPER users and what are their CIPER roles?

The CIPER users are the persons registered in the OPULUS Web system and granted to access the CIPER system.

A CIPER role determines a set of available functions and data for users. The available CIPER role types are: SOR (System Owner Representative), CSPR (CIPER Service Provider Representative), and administrator.

SOR users are delegated by the system owner companies. Their main task is to answer the questions in the CIPER questionaire according to the actual system properties.

CSPR users are delegated by the CIPER service provider. They supervise the assessment process and provides expert help for the SOR users in any problem related to the CIPER service.

Administrators are responsible for registrations, user access control, and the content of CIPER questionaire explanations and knowledge base references.

Note that the CIPER questionaire of a given system can be accessed only by the authorized SOR and CSPR users.