IQ Protocol

Main Process

 

Is a platform that provides the integrated content, tools, and methodologies that you need to implement, support, operate, and monitor your enterprise's solutions in the pharmaceutical industry.

The URS documents are the descriptions of the functionalities that the customer wants to run in the system. These documents can be managed with SAP Solution Manager.

The roadmap of SAP Solution Manager supports the full documentation of the different phases of the project, including predefined accelerators with versioning and status management.

The business blueprint phase of SAP Solution Manager allows the management and documentation of all kinds of templates, documents, etc., with versioning, status management, and definition of electronic signatures.

The platform integrates content, tools, and methods for implementation, support, operation and control;

enables central administration and control of allocated, decentralized applications; and provides automatic functions for evaluation of problems.

Tools

• SAP Solution Manager

Remark

• Procedural requirements for customers are not related to capabilities of SAP.
• The customer has to verify that all appropriate hardware and software were ordered, received, and correctly installed.

When an application is installed, an IQ protocol should be written. The IQ protocol describes how the hardware and the system and application software should be installed.

The IQ results should include the following:

• Documentation of the installation procedure followed by the installer
• Notes made by the installation technician during installation
• Records of data entered or received from the system during installation
• Obtainment of original installation and diagnostic media, documentation, and deliverables
• Variances from the IQ protocol

If the results are extensive, then a summary report indicating whether the installation was performed according to the protocol should be written. A knowledgeable and responsible person who has reviewed all the actual results should write the report, which should state:

• Whether or not the installation procedure was followed (as shown by the documentation generated by the person performing the installation)
• Whether the environmental and ergonomic recommendations made by the supplier were met
• Any deviations from the manufacturer’s procedures or recommendations (these should be explained and justified)

Services

• IT Infrastructure Installation and Integration

Remark

• Procedural requirements for customers are not related to capabilities of SAP. The customer has to verify all appropriate hardware and software were ordered, received, and correctly installed.