Best practices to avoid Data integrity issues and ALCOA plus

What is data integrity?

 Data integrity is now a common issue found during regulatory inspections in the pharmaceutical industry. 
    Data manipulation, data alteration, and data deletion are the common issues observed in most of the regulatory inspections in various pharmaceutical organizations.
 
     Data integrity issues, non-compliance, violation of Alcoa plus are major reasons to fail inspection in Pharmaceutical industries, then the major question arises is what is data integrity? and what is the importance of data integrity?

  The acronym ALCOA introduced in the 1990’s. It is used/adopted by the regulated industry as a framework for ensuring data integrity and it is key for good documentation practices in the Pharmaceutical industry.
Data integrity, Alcoa plus plays a major role in Pharmaceutical industries to comply with the regulatory requirements. 

Here we will learn about what is data integrity? And what kind of mechanism we can place to fix the data integrity issues.

  1. Definition of data integrity?
  2. What are the common data integrity issues?
  3. Impact of data integrity issues?
  4. How to fix data integrity issues?
  5. Conclusion
These are the contents which we will learn today let’s start one by one.

1. 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.

 The data generated from starting to the end means initial data generation, processing, recording, use, retention, archival, retrieval, and destruction of data should comply with the quality standards.
   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.

 Data integrity can be ensured through ALCOAplus

What is Alcoa Plus In Pharmaceutical?

ALCOA is the tool to shows assuring of 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.

ALCOA plus is relates to the data, whether paper or electronic format which is defined by the USFDA guidance.
data-integrity-alcoa-plus
ALCOA plus

Acronyms of Alcoa Plus or Full form of Alcoa Plus:

ALCOA Plus is an acronym of
A-Attributable,
L-Legible,
C-Contemporaneous,
O-Original,
A-Accurate,
C-Complete,
C-Consistent,
E-Enduring, and
A-Available.

Let us understand ALCOA Plus:

Attributable:

It defines that who performs the activity, what is the original place, and at what time the activity is performed.

Legible:

It defines that reported activity should be in a readable, understandable format throughout the lifetime duration.

Contemporaneous:

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.

Original:

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.

Accurate:

It defines that data should be error-free. If any corrections made that should be justified properly.

Complete:

It defines that data generated should be complete with raw data. Any justification, repetition, or any kind of other data has to be attached.

Consistent:

It defines that all data should be in chronological order with time and date stamped.

Enduring:

It defines that the data should be available with proper legibility for long periods of the data.

Available:

It defines that the data should be easily accessible whenever required for the lifetime of the data.

2. What are common integrity issues in pharmaceutical?

Here for a better understanding, we will specify two types of integrity issues.
i. Intentional ii. Non-intentional

i. Intentional integrity issue:

In all organizations to maintain the regulatory standard having its own cGMP practice and procedure. The person who is working in the facility is knowingly not following the cGMP practices or define the procedure and hiding the wrong things whatever hi has done. Those activities come under intentional integrity. Such type of activities are considered as intentional integrity.
This type of integrity issue may cost a high impact on the organization such as form 483 observation, warning letter, and some time import ban also. In such cases, organizations may separate or terminate the person from an organization who do that activity.
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. 

The organization has a right to investigate non-compliance and if found guilty then the organization can take proper action on the person.

iI. Non-intentional integrity: 

Non-intentional integrity issues may happen due to inadequate knowledge of the system, lack of proper training, lack of experience. In such cases, organizations may conduct an investigation to know the root cause of the integrity issue. If found guilty then the organization may provide proper training to the personnel to avoid integrity issues.

3.impact of data integrity issue in pharmaceutical?

Due to data integrity issues found in the regulatory inspections, the inspector will issue Form 483 observation, warning letter, import ban, and the organization will face a huge impact on the market. Due to data integrity issues, the organization may lose its business. Once data integrity issues found the reliability and trustworthy ness also loose by the regulator on the organization. The organization’s reputation will get down and it will impact revenue as well. 

4. How to fix data integrity issues in pharmaceutical?

There are 9 best ways to fix data integrity issues:
  1. Selection of appropriate system and vendor
  2. Risk-based validation
  3. Good quality management system
  4. Change management system
  5. Disaster management system
  6. Regular internal audits
  7. IT system
  8. Be accurate system
  9. Archival and retrieval system
Related search:

1. Selection of appropriate system and vendor

The selection of the proper systems and vendors is an initial requirement to maintain the data integrity issues. The selected system should comply with regulatory requirements and the vendor should be approved with current GMP requirements.

2. Risk-based validation

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.

3. 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 activity performed.
To check the compliance level into the facility the periodically audits review has to conduct.

4. 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.

5. Disaster management system

The disaster management system is to act on the backup and recovery of the data for a long life. If a natural calamity happens to like fire, flood to avoid data lost should have a backup in the form of a floppy, Disc, or any other format.
To avoid the power supply interruption UPS (Uninterrupted Power Supply) supply should be in place.
The alternative source, like software or system, should be available that can record and stored data while power shortages and power downtime.

6. 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 the third-party auditor to check compliance into the facility.

7. IT system

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 to check administrative rights.

8. 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 that data location from where the data generated and stored at a designated place.

9. Archival and retrieval system

To maintain electronic data, paper data, disc or floppy data, archival and retrieval of data system should be on place to verify the archival and retrieval of data throughout the life cycle.

5. Conclusion:

Data Integrity is an integral part of the pharmaceutical industry to assure the reliability and quality of drug products to the regulator.
It is important to maintain data integrity to fulfill the regulatory requirements and to counter the observations such as 483, warning letter, import ban, and sometimes consent decree also.
In this article, we learn about the;
1. What is the Meaning of Data integrity? 
2. What is Alcoa Plus?
3. What is the Importance of Data Integrity?
4. What is the importance of ALCOA Plus?
5. Definition of Data Integrity?
6. Acronyms of Alcoa plus?
FDA guidance for data integrity
Data integrity requirements FDA
Data integrity guidelines FDA
FDA data integrity guidance final
Meaning of data integrity

NDA in Pharmaceutical

ANDA in Pharmaceutical

Types of Validation

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