Alcoa Plus Principles
ALCOA + Principle:
ALCO + is a framework that ensures data integrity. It includes the ALCO principle with the addition of a few other attributes i.e.
· Complete: Complete information about all the critical steps involved in the whole process is required. All recorded data requires an Audit trail to ensure that nothing is missing or lost.
· Consistent: Good documentation practices should be applied during the process. Data must have a date and a timestamp
· Enduring: Long term storage of recorded data. It must be kept properly so that it remains intact andaccessible during the record retention period.
· Available: Data must be accessible and available in readable format whenever it is required for review.
Let’s take an example of a data Integrity issue and see it through the ALCO + Principle attributes for better understanding.
Examples of Data Integrity issues at Attributable level : alcoa plus principles
Deletion of selective data, deviation from standard procedures, omitting information on the purpose, and/or retaining any data.
1-Complete:
· The signature log is missing which is necessary to keep the record of a person’s entries.
· Data is recorded without instrument name, serial number, a person who performed the task or without the complete analysis.
· When collaborating as a team but names of all the team members are not present on data.
· Original data copy is not present. Only raw data is being kept for the record.
2- Consistent:
· Inconsistency between batch time and operator time.
· Ambiguous data or process due to faulty design of the worksheet
· Poor data record due to system error e.g. rpm of cfg
· Inability to save the data with a proper name and date record.
3- Enduring:
· Loss of data during printing.
· Incompatibility of data with the new soft wares result in loss of data
· Poor quality of reports made it hard To understand the data recorded.
· Operators record the data temporarily and didn’t document it on the official report.
· No backup files in case of system shutdown result in loss of data.
4- Available another alcoa plus principles
· Data not stored in a single file can result in loss of a partial data.
· Failure to make a backup, resulting in data loss over time.
· Disposal of the data before the retention period is over.
Data Integrity Issues:To enhance alcoa plus principles
1- Data Recording Issues:
· Loss of data
· Backdating/backlogging
· Data Fabrication
· Data manipulation
· Use of old data
· Data Traceability issues
· A mismatch between recorded data
· No audit trail
· Omitting negative data
· Disabling data trails
2- Operational Issues:
· Lack of Process Knowledge
· Lack of regulatory knowledge
· Use of un-Validated Software
· SOP deviations
· Inadequate reporting
· Inadequate access authorization
· Re-running sampling
· Unofficial Analysis conduction
· Unofficial batch sheets and reports
Data Integrity – Implementation for proper implementation of alcoa plus principles
Important Preventive Measures to avoid data integrity issue:
‘An ounce of prevention is worth a pound of cure’, this saying also goes for the pharmaceutical industry, it’s better to take important steps beforehand.
· Firstly identify the risk factors that can lead to data integrity in your process.
· Proper Protocols Placement at all the steps.
· Proper education and technical training of individuals involved in data recording.
· Complete implementation of Quality risk management processes.
· Internal Audit and inspections
· Validated and Up-to-date computer system
· Ensure quality management system is fully equipped with current requirements.
· Ensure on-time and proper documentation.
· Timely performance review meetings.
· Support quality culture within the organization.
Ways to Ensure Data Integrity:
An Organization must have a data integrity policy in place with complete guidelines about how to prevent the data integrity issues and should properly train the staff about that and defines
· Data breach and its consequences
· Proper record logging method
· Should have worksheet templates in place for the daily activities
· A proper backup system should be in place
· Validate systems periodically
· Select appropriate system and service providers
· Should assign roles to individuals
· Limit the access of templates to authorized individuals only.
· Control access of samples to authorize personnel
· Limit access to storage data to reduce risk of data amendments
· Control accessibility to raw data and batch records to ensure the accuracy of data
· Archive data regularly
· Audit the audit trails periodically to check the accuracy
· Set an activity logging clock
· Automate the system to remove the human error factor
· Check the printers and computers from time to time
· Check software updates
Responsibilities of a person in charge of data integrity:
· Be honest and accurate
· Always inform the supervisor in case of any alteration or deviations
· Perform data recording activity on daily basis on a proper record sheet
· Always record date and time
· Never record activities on back dates
· Make an activity performing plain.
Areas to focus on: alcoa plus principles
The main focus should be on PPP
1-Person: This should include three main things
· Training and education of the employees as they are involved in handling the process and have direct impact on the process
· Ensure the effectiveness and implementation of training practices.
· Supportive and accountable organizational Culture is a must
2-Place:
· Facilities should be equipped with proper equipment
· Qualify IT and validate System
· Proper management review system should be in place
3-Preventions:
· Ensure internal audit system
· Ensure the proper quality management system
· Ensure periodic assessment of all the procedures
Points to Ponder:
As most of the data integrity issues are related to ethical problems so we should ask ourselves.
Are we following ALCO Principles?
Do our facilities meet all the requirements?
Have we tried to find out the cause of deviation?
Are all the employees properly trained?
Do we have a supportive organizational culture?
When was the last time we did system validation?
Have we assigned the roles properly?
Read more about ALCOA FDA on official FDA site here
