The will be developed/modified as part of {Describe, in broad terms, the project of which the PCS development is a part. Include specific project identifiers, like project number(s), products, and key processing technologies.}
II.1.1.2.Key Objectives
The key objective is to provide a process control system with the required functionality and flexibility while simultaneously meeting the requirements of ISPE GAMP 4, cGMP, FDA’s 21 CFR Part 11, ISA S88.01, and policies and procedures. The benefit of meeting or exceeding these key objectives is a profitable manufacturing facility offering flexibility to meet market demand.
II.1.1.3.Anticipated Benefits
The following is a list of the major benefits anticipated from the project:
The is a manufacturing facility located in designed to produce . The following model identifies site equipment pertinent to this project:
{The diagram below is provided as a sample to indicate the appropriate level of detail for the facility overview. Replace with diagrams and/or information specific to your facility.}
II.1.2.1.Existing Facilities and Equipment
II.1.2.2.New Facilities and Equipment
II.1.2.3.Modifications to Existing Facilities and Equipment
II.1.3.Automation Overview
The following diagram identifies site automation systems pertinent to this project:
{The diagram below is provided as a sample to indicate the appropriate level of detail for the automation overview. Replace with diagrams and/or information specific to your facility.}
The PCS maintains a secure environment in accordance with cGMP, GAMP, and FDA 21CFR Part 11 requirements using S88.01 standards. The PCS monitors and controls the cGMP portion of the to:
Provide an interactive illustration of the process for operator information and process control
Provide equipment status and monitoring functionality
Provide sequential process control via control modules, phases and/or procedures
Acquire process data for real-time and historical analysis
Tailor procedural control of the process via parameter modification
II.3.Simulation System
The PCS vendor scope includes the hardware and packaged software necessary to configure and support an independent Simulation System. The Simulation System shall be initially installed at the vendor site and utilized for the development and factory testing of the application software. When the application software is ready for installation at the facility, it will be transferred from the Simulation System to the facility PCS hardware platform. Subsequently, the Simulation System hardware and packaged software will also be moved to the site, and utilized for PCS application maintenance and enhancement activities.
