Standard Operating Procedure for Data Lifecycle Management

Purpose

The purpose of this SOP is to establish policies and procedures for the effective management of data throughout its lifecycle, from creation or acquisition to disposal, within the pharmaceutical manufacturing facility. This SOP aims to ensure data integrity, availability, and compliance with regulatory requirements.

Scope

This SOP applies to all personnel involved in the creation, processing, storage, and disposal of data within the pharmaceutical manufacturing facility.

Responsibilities

• Data Steward: Responsible for overseeing the implementation of data lifecycle management practices, including data categorization, access controls, and disposal procedures.
• IT Personnel: Responsible for providing technical support, implementing data management tools, and ensuring the security and availability of data throughout its lifecycle.
• Data Users: Responsible for following data management procedures, including data entry, documentation, and adherence to data retention and disposal policies.

Procedure

1. Data Categorization: Classify data based on its sensitivity, criticality, and regulatory requirements. Categorize data into different levels to determine appropriate management practices throughout its lifecycle.
2. Data Entry and Documentation: Follow standardized procedures for data entry to ensure accuracy and completeness. Maintain detailed documentation for each data set, including metadata, to facilitate effective data management.
3. Data Storage: Implement secure storage solutions for different categories of data. Define access controls to restrict data access to authorized personnel based on their roles and responsibilities.
4. Data Retrieval: Establish procedures for retrieving and using data based on user permissions. Ensure that data retrieval is efficient and complies with data access policies.
5. Data Sharing: Define protocols for sharing data within and outside the organization, ensuring compliance with privacy regulations and data sharing agreements. Implement secure methods for data transmission.
6. Data Retention: Develop and implement data retention policies specifying the duration for which data should be retained based on its category. Regularly review and update retention policies to comply with changing regulatory requirements.
7. Data Disposal: Establish procedures for the secure and documented disposal of data at the end of its lifecycle. Ensure that data disposal methods comply with environmental regulations and data privacy requirements.
8. Data Archiving: Archive data that is no longer actively used but must be retained for compliance or historical purposes. Implement secure and easily retrievable archival solutions.
9. Data Backup: Implement regular data backup procedures to ensure data availability and protection against data loss. Verify the effectiveness of backup and restoration processes through periodic testing.
10. Periodic Review: Conduct periodic reviews of data management practices to ensure ongoing compliance with policies and procedures. Address any identified issues or deviations promptly and document corrective actions taken.
11. Training: Provide training to personnel involved in data management, emphasizing the importance of data lifecycle management, and ensuring awareness of relevant policies and procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Data Categorization Policy
• Data Entry and Documentation Procedures
• Data Storage and Access Control Guidelines
• Data Retention and Disposal Policies
• Data Archiving Procedures
• Data Backup and Restoration Records
• Periodic Review Reports
• Training Records

Reference

ISO/IEC 27002 – Information technology – Security techniques – Code of practice for information security controls

SOP Version

Version 1.0