Here we will learn about what is data integrity? And what kind of mechanism we can place to fix the data integrity issues.
- Definition of data integrity?
- What are the common data integrity issues?
- Impact of data integrity issues?
- How to fix data integrity issues?
These are the contents which we will learn today let’s start one by one.
What is data integrity (Definition) in pharmaceutical?
Data integrity is a complete, consistent and accuracy of the data throughout the life cycle.
This is a simple Definition of Data Integrity.
Data should be complete with all activities involved from initial to destruction.
The data generated should be consistent and accurate throughout the life of the data.
What is Alcoa Plus In Pharmaceutical?
ALCOA is the tool to shows assuring of the manufacturing facility later on by adding some parameters in Alcoa, the most powerful and trustworthy tool is formed as Alcoa plus.
Alcoa plus is one of the tools to ensure data integrity. ALCOA plus maintains reliability and quality on the manufacturing facility’s system.
Acronyms of Alcoa Plus or Full form of Alcoa Plus:
Let us understand ALCOA Plus:
It defines that reported activity should be in a readable, understandable format throughout the lifetime duration.
It defines that recorded data should be on time or in real-time. If Real-time data reporting is not possible then another person as reported by and activity performer as done by can do reporting.
It defines that the data reported should be a true copy, it’s initially reported data. Xerox copy will not be original data. Xerox copy can be considered when initial data will confirm the authenticity of the copies.
It defines that data should be error-free. If any corrections are made that should be justified properly.
It defines that data generated should be complete with raw data. Any justification, repetition, or any kind of other data has to be attached.
It defines that all data should be in chronological order with time and date stamped.
It defines that the data should be available with proper legibility for long periods of the data.
It defines that the data should be easily accessible whenever required for the lifetime of the data.
What are common integrity issues in pharmaceutical?
i. Intentional integrity issue:
Intentional integrity is a violation of compliance.
Non-compliance such as manipulation, alteration, falsification, fabrication, deletion or modifications to get the final results in a acceptable level are not allowed in the Pharmaceutical industry.
ii. Non-intentional integrity:
Impact of data integrity issue in pharmaceutical?
How to fix data integrity issues in pharmaceutical?
- Selection of appropriate system and vendor
- Risk-based validation
- Good quality management system
- Change management system
- Disaster management system
- Regular internal audits
- IT system
- Be accurate system
- Archival and retrieval system
Selection of appropriate system and vendor
The system which is used in a GxP environment should be validated. System validation can be done by an internal trained person or external vendor. To determine the complexity of the system GAMP5 (Good Automated Manufacturing Practices) can be referred for risk-based validation. The Risk-based validation of the system increases the chances of reliability of the data.
Good Quality management system
To comply with GxP compliance the activity performed in the facility should have an audit record. The audit record in such a format should not be modified, erase, or delete. The audit record should represent the chronology of who, when, what, and why the activity was performed.
To check the compliance level in the facility a periodic audits review has to conduct.
Change management system
A change management system is a crucial tool to address the change history of the data. For changes made in the data should have proper traceability to identify what are superseded changes.
Disaster management system
The disaster management system is to act on the backup and recovery of the data for long life. If a natural calamity happens to be like fire, flood to avoid data loss should have a backup in the form of a floppy, Disc, or any other format.
To avoid power supply interruption UPS (Uninterrupted Power Supply) supply should be in place.
An alternative source, like software or system, should be available that can record and stored data while power shortages and power downtime.
Regular internal audits
It’s a regulatory requirement that the facility should comply with all GxP compliance levels. To check the compliance level into the facility internal audit has to conduct through the management. Or the facility can hire a third-party auditor to check compliance into the facility.
The IT systems have an important role in the facility. IT system is responsible to maintain, cybersecurity to avoid malware attacks, system access control, data backup and recovery, system passwords, system interconnections, server-based system, data storage system, UPS arrangements, and checking administrative rights.
Be accurate system
1. Calibrated instruments Tobe used.
2. Instruments should be calibrated regularly.
3. System should fulfill regulatory requirements. ( Such as 21 CFR, GAMP 5, or any other regulatory)
4. System should capable to provide alarm messages while communication failure, device problem, and tempering.
5. Network system should be accurate to show the data location from where the data is generated and stored at a designated place.
Archival and retrieval system
To maintain electronic data, paper data, disc, or floppy data, archival and retrieval of data systems should be in place to verify the archival and retrieval of data throughout the life cycle.
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