Like the holy books in every religion, the ALCOA principles should be the holy books in all pharmaceutical and medical device manufacturing facilities all over the world. All the data, the research work, clinical trial data, validation / qualification data, manufacturing batch record, monitoring records etc. are equally important and they form the foundation of proof of the work being carried out. These data must be integral and the data integrity must be proved. If the data integrity is breached, it gives a serious indication of malpractices, falsification and manipulation in the data management of the organization. Here comes the importance of the principles laid to ensure data integrity through ALCOA+. Data integrity is very essential in pharmaceutical and medical device manufacturing facilities. The only way to achieve data integrity is to follow the ALCOA+ principles. After all, record speaks finally!!
What is ALCOA+?
ALCOA+ is a framework or set of principles that ensures data integrity. The ALCOA has been since the 1990’s and is used by regulated industries as a framework for ensuring data integrity. ALCOA was first coined by Stan W. Woollen from the FDA’s Office of Enforcement. It is key to Good Documentation Practice [GDP]. ALCOA principles ensure data integrity and they apply to the following records.
Electronic records – Data recorded using equipment that ranges from simple machines to complex and highly configurable computerized systems.
Paper records – Manual recording on paper of a manual observation or of an activity.
Hybrid – where both paper records and electronic records constitute the original record.
Others –Photography, images, chromatography plates, and more.
Data Integrity as per United states Foods & Drugs Administration [USFDA]
Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy and accurate [ALCOA].
Data Integrity as per Medicines and Healthcare products Regulatory Agency [MHRA]
Data integrity is defined as ”the extent to which all data are complete, consistent and accurate throughout the data lifecycle”.
Difference between ALCOA and ALCOA+?
ALCOA stands for Attributable, Legible, Contemporaneous, Original and Accurate. ALCOA was then expanded to ALCOA +, by the addition of a few more concepts which are Complete, Consistent, Enduring and Available. They were added to ALCOA in 2010.
All the ALCOA principles are explained in simple words with pictures. Pictures are given for an easy reference as our brain remembers easily the images to correlate just like in childhood when we learned the nine planets by “My Very Excellent Mother Just Served Us Nine Pizzas” for the order of the planets Mercury, Venus, Earth, Mars, Jupiter, Saturn, Uranus, Neptune and Pluto.
- Attributable
Information is captured that identifies the source of the data.
Example:
1.During a validation exercise, test results should be initialed and dated by the person executing the test.
2. Adjustment of a setpoint on a process or monitoring system should be made by an authorized user and the details of the change logged in an audit trail.
3. A correction on a lab record should be initialed and dated to show when and who made the adjustment.
2. Legible
Information is human-readable. Reports, tables, and listings should be legible.
Example:
1.Good Documentation Practice will always promote the use of indelible ink when completing records.
2.When making corrections to a record, ensure a single line is used to strike out the old record.
3.Controlling your paper records/forms for the information to be recorded.
3.Contemporaneous
Information is recorded at the time of data generation or event observation.
Example
1.If executing a validation protocol, tests should be performed and their results recorded as they happen on the approved protocol.
2.Data that is logged, or testing that is performed electronically, should have a date/time stamp attached to the record.
3.Electronic systems that log data should have their system clocks synchronized.
4.Use of a master clock system that synchronizes to the IT network so wall clocks within labs and processing areas are synchronized.
4.Original
Source of data is available
Example:
1.Ensure validation test results are recorded on the approved protocol. Recording results in a notebook for transcription later is prohibited.
2.If your original data is hand written and needs to be stored electronically, ensure a “true copy” is generated, the copy is verified for completeness and then migrated into the electronic system.
5. Accurate
Data can be verified as correct via repeatable calculation.
Example:
1.Use a witness check for critical record collection to confirm accuracy of data.
2.Consider how to capture data electronically and verify its accuracy. Build accuracy checks into the design of the electronic system.
3.Place controls/verification on manual data entry.
ALCOA+ CCEA
6. Complete
All data are present
7.Consistent
Data are compatible, free from variation and non-contradictory.
8. Enduring
Data are preserved and retrievable during its lifetime according to the data type retention period.
9. Available
Accessible anytime by anyone who needs the data.
Conclusion
Though it sounds so simple, it needs lot of monitoring and exercise. The implementation will be successful only after lot of trainings. The basics, outcome of data integrity has to be sowed in the minds of all in the Pharmaceutical and Medical industries. The main challenge in Data Integrity compliance is the drive to convert from manual entry paper records to electronic records. In simple words, if principles of ALCOA+ are followed, the safety of the drugs / devices are assured to the patient and if not followed the trust will be broken and can never be repaired or mended again!!
Choice of path of following ALCOA+
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“As how true history depends upon the written manuscripts, data are the manuscripts to maintain good health of the patients and data integrity breach is disservice to the human population”.
Muthu
Note-The images given for representation in this blog are taken from Google Images. Many thanks for Google.
Beautifully drafted with examples for one to understand and absorb. Good work and keep it up.
Thank you Jignesh for the compliments. It is a fuel for the hard work!!