IT Systems Used in Procurement – Standard Operating Procedure

1) Purpose

To establish a standardized process for the utilization, management, and maintenance of IT systems used in the procurement process to ensure efficiency, data accuracy, and compliance within the pharmaceutical purchase department.

2) Scope

This SOP applies to all IT systems used in procurement activities, including enterprise resource planning (ERP) systems, procurement software, and other digital tools.

3) Responsibilities

Procurement Manager: Responsible for overseeing the implementation and use of IT systems in procurement.
IT Department: Responsible for the technical support, maintenance, and security of IT systems.
Procurement Team: Responsible for utilizing IT systems according to established procedures and reporting any issues.

4) Procedure

4.1) Selection of IT Systems:
4.1.1) Identify the requirements for IT systems based on procurement activities and objectives.
4.1.2) Evaluate and select IT systems that meet the identified requirements, ensuring they are compatible with existing infrastructure.

4.2) Implementation of IT Systems:
4.2.1) Develop an implementation plan, including timelines, responsibilities, and training needs.
4.2.2) Coordinate with the IT department to install and configure the selected systems.
4.2.3) Conduct training sessions for procurement staff to ensure proper use of the new systems.

4.3) Data Management:
4.3.1) Establish data entry protocols to ensure accuracy and consistency in the IT systems.
4.3.2) Regularly update and maintain procurement data within the IT systems.
4.3.3) Implement data backup procedures to prevent data loss.

4.4) System Maintenance:
4.4.1) Schedule regular maintenance and updates for IT systems to ensure optimal performance.
4.4.2) Coordinate with the IT department for troubleshooting and resolving technical issues.
4.4.3) Monitor system performance and report any anomalies or issues to the IT department.

4.5) Security and Access Control:
4.5.1) Implement security measures to protect procurement data from unauthorized access or breaches.
4.5.2) Define access levels and permissions for procurement staff based on their roles and responsibilities.
4.5.3) Conduct regular audits of access logs to ensure compliance with security protocols.

4.6) Continuous Improvement:
4.6.1) Regularly review and assess the effectiveness of IT systems in supporting procurement activities.
4.6.2) Solicit feedback from users to identify areas for improvement and implement changes as necessary.
4.6.3) Stay informed about new technologies and updates in procurement IT systems.

4.7) Documentation and Record Keeping:
4.7.1) Maintain detailed records of IT system configurations, user manuals, and training materials.
4.7.2) Ensure documentation is complete, accurate, and readily available for audits and future reference.

5) Abbreviations, if any

• ERP: Enterprise Resource Planning
• IT: Information Technology

6) Documents, if any

• System Implementation Plans
• Data Entry Protocols
• Maintenance Schedules
• Access Control Policies
• System Configuration Records

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211, ISO 9001:2015
Industry Standards: Best practices in IT system management for procurement

8) SOP Version

Version 1.0