Data integrity is the completeness, accuracy and consistency of data, regardless of the format in which it is generated, retained or used. Maintaining the integrity of data pertaining to GMP activities is very important for maintaining compliance with the regulations. Best practices for maintaining data integrity not only encompass the Quality Control (QC) data but also the data which is generated by other activities like manufacturing, validation, packaging, materials management, facilities management and more. An effective way of maintaining data integrity involves risk-based and holistic assessment of the systems that store the data related to GMP operations, and include manual, electronic and hybrid systems.
Here are some of the best practices for maintaining GMP data integrity:
- Understanding Part 11 Requirements
The first step of working towards data integrity includes identifyingand understanding the Part 11 requirements applicable to electronic records and signatures used in GxP procedures and activities. Firms that majorly operate through paper based systems should also consider that laboratory instruments are associated with computer systems and thus they are not exempted from complying with regulations. Part 11 regulations must be properly understood to know about their applicability.
2. Data Management
Data management must be incorporated effectively into the quality system for ensuring the reliability and security of the data. Staff should be trained and the management should monitor that the procedures are being implemented properly. It is the duty of senior management to ensure that the firm has enough funding and is putting much effort for data management to make sure that the data in the firm is always complete, valid, secure and accurate.
3. Updating Quality Systems
For electronic records and computer systems, quality system procedures should be revised whenever required. Computer systems used in the firm need to be appropriately developed, tested, and assessed on a regular basis to ensure that they are properly validated. Changes made to the systems should be timely evaluated for their impact on various GMP operations. The quality unit, having proper training and expertise, should review and approve the changes made to the computer systems.
4. Laboratory Instruments Controls
It is also extremely important to comply with the regulations related to the computer systems associated with laboratory instruments. Although this area doesn’t receive much attention from regulators, there have been instances where warning letters have been issued to firms regarding issues in this area.
5. Data Integrity Assessment in Internal Audits
The firm must always incorporate data integrity assessment in its internal GMP audit programs. Internal audit staff must be trained in data integrity assessment and their training must be documented. For company-specific needs and newly published enforcement actions the firm must add or modify additional considerations. If the firm is outsourcing the audit functions to a third party, it should ensure that the auditors have proper training in data integrity assessment.
6. Updated About Regulations
Firms must always stay informed and updated about the latest regulations. Changes in enforcement actions must be monitored and implemented. It’s also important to stay aware about the current trends. This would help the firms in keeping up with the latest trends and complying with the regulations in an effective manner.
Although quality control laboratory is the most common area where data integrity issues are detected, it’s not the only one. GMP data integrity must be properly implemented in all the GxP areasfor maintaining data integrity and, thus, compliance with laws and regulations.