Standard Operating Procedure for Data Integrity Training Program

Purpose

The purpose of this SOP is to establish procedures for the implementation and management of a Data Integrity Training Program within the pharmaceutical manufacturing facility. This program aims to educate personnel on the principles of data integrity, regulatory requirements, and best practices to ensure the accuracy and reliability of electronic data.

Scope

This SOP applies to all personnel involved in the generation, processing, and management of electronic data, including operators, IT personnel, quality control personnel, and quality assurance personnel.

Responsibilities

• Training Coordinator: Responsible for coordinating and overseeing the Data Integrity Training Program, including the development of training materials and the scheduling of training sessions.
• Department Supervisors: Responsible for identifying the training needs of personnel within their respective departments and ensuring that employees attend the required training sessions.
• Employees: Responsible for actively participating in the Data Integrity Training Program, completing assigned training modules, and applying the knowledge gained in their daily activities.

Procedure

1. Training Needs Assessment: Conduct a periodic assessment to identify the data integrity training needs of personnel within each department. Consider factors such as job roles, responsibilities, and changes in regulations.
2. Development of Training Materials: Collaborate with subject matter experts to develop comprehensive training materials covering topics such as data integrity principles, regulatory requirements, best practices, and the importance of data accuracy and reliability.
3. Scheduling Training Sessions: Establish a schedule for Data Integrity Training sessions based on the identified needs. Ensure that all personnel attend the required training within the specified timeframe.
4. Training Delivery: Conduct training sessions through various formats, including in-person sessions, webinars, or e-learning modules. Provide opportunities for interactive discussions and clarification of any questions or concerns raised by participants.
5. Assessment and Certification: Evaluate participants through quizzes, assessments, or practical exercises to ensure understanding. Issue certificates of completion to personnel who successfully complete the training program.
6. Documentation: Maintain records of training attendance, assessment results, and issued certificates. Document any feedback received from participants and use it to enhance future training sessions.
7. Periodic Review and Update: Conduct periodic reviews of the Data Integrity Training Program to assess its effectiveness. Update training materials and methods based on feedback, changes in regulations, or emerging best practices.
8. Integration with Onboarding: Ensure that new employees receive Data Integrity Training as part of their onboarding process. Tailor the training to align with their specific roles and responsibilities.
9. Communication: Communicate any updates or changes to the Data Integrity Training Program to all relevant personnel. Encourage continuous learning and adherence to data integrity principles.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Training Needs Assessment Report
• Data Integrity Training Materials
• Training Attendance Records
• Certificates of Completion

Reference

EU GMP Annex 11 – Computerized Systems

SOP Version

Version 1.0