ALCOA Plus [ALCO+] is the most powerful and sharp compare to previously introduced ALCO has the great importance regarding data integrity in pharmaceuticals company. Data security is the provocative questions is the pharmaceutical and related healthcare sector. Adulteration of data leads to serious health hazard to the end user.
All of the regulatory authority of healthcare related sector has taken their active place against data Adulteration. Data must be accurate, No an Adulterate data is accepted at any situation. Everybody desire the right data at any time any place. Data violation define the serious non-compliance of GMP.
ALCOA is abbreviate form, which indicate Attributable, Legible, Contemporaneous, Original and Accurate. In the period ALCOA, extend to ALCOA Plus[ALCOA+] by addition of Complete, Consistent, Enduring and Available.
In previous time all of the GMP compliance company use ALCOA, now they use ALCOA Plus concept to capture its place the most dependable tool for data security. Most of the GMP oriented company taken the tool for data security and data quality. ALCOA Plus ensure the data security and Integrity. All of the major GMP authority choose ALCOA Plus and implemented their respective directive. ALCOA determine the all-out of data quality. UK MHRA, FRA, TGA, WHO purely involved in data security, quality and data integrity.
The ALCOA and ALCOA Plus concept has been illustrated for better understanding of data related matters.
1. Attributable
Attributable define that the data must be easily traceable, so that anyone can identify that a specific person has collect the data in define time and noted down correctly. To correct any type of error regarding data recording, correction to be made in such way that anyone can read the error data and the corrected data easily. Reason must be noted down with specific signature and date.
Any document subject to data recording must be contains specific field where anyone can note down his/her name then signature and date option. Specific must contains sufficient space so that anyone can record data easily. If any alteration required, put a straight line over the error data then write down the actual data with signature and reason. If space is not available the put an asterisk mask then put another asterisk in a place where sufficient space for signature and reason recording.
2. Legible
Most of document in pharmaceutical company subject to data recording in specific field of a specific document. Entered data must be readable. Data which can be easily readable defined as legible data. Unclear data create confusion to reader and result of a specific test or critical point create unwanted error. The personnel who are responsible to entered data must be trained on GDP [Good Documentation Practice].
Permanent ink or indelible ink to be use to record the data, ball point pen to be use instead of fountain pen. Different color ink to be use to identify the recorded data easily i.e. if the printed document is black color then blue color ink pen can be use to record the data. Similar color ink pen with printed document create delay to identify the specific data.
The input data must be clear and easy to traceable who is responsible to input the data. Data should be entered in such way that no visibility of data subject to misunderstanding to the reader. Anyone who is going to deal with the recorded data must be comfortable with it.
3. Contemporaneous
All the data subject to recoded in document must be recorded on time indicate contemporary data. All data must be entry on the specific field of the document, just after completion of the work with signature and date, if any error occur during data recording then GDP to be follow to correct the issue.
If any correction identified after recording of data in the later date then actual data to be entered data and time with signature on that date. No advance or later data entry is not indicate cGMP culture at your firm. On time data recording is the pre-requisite of the compliance.
A person on the specific date may be absent or leave or fall any unwanted situation, if he fail to entry the data cause serious non-compliance so in time data entry to be ensure. If require, a training session may be conduct to emphasize the importance of contemporary data. Contemporary data culture on the document define that your firm is up to date and ready to face any compliance audit both local and global.
4. Original
To protect the data integrity, the original record must be preserved in such way that it can be preserved till it expiry. Batch document and some documents to be kept additional one year from its product expiry but validation document lasts company life so all type of document preservation may not same. A policy to be develop to preserve the documents and record.
Some document need to duplicate in multiple copy, in this case the creator must ensure the authenticity of the multiple copy with the help of site quality head other that QA documents. A controlled copy seal may be introduce for this issue.
5. Accurate
All data subject to record in the document must be error free. Data can’t be change at any cost. Alteration of data is strictly prohibited. Print out any data create its accuracy, hand written or manually input data, subject to change or alteration. If any facility declare to print out option then manually input data is totally invalid. You must follow the machine print out. To maintain the data quality is the big compliance issue.
Alteration of any digit in manually define the serious discrepancy data quality. It is undesirable to may any digit to next digit or similar digit. Data rounding may be accepted as per USP method but it is not mandatory to follow.
6. Complete
If it’s declare that the data is complete, then it means no alteration, deletion, only original data has been taken from its actual documented time. Incomplete data create haphazard situation to identify the original. Incomplete data recording leads the false result. Data to be record at actual from its predefined time as mention on the document.
If any document declare that you have to record data in 45 minutes interval then you have to record the data at 45 minutes interval not 50 or 60 minutes interval. If you note/record data other than 45 minutes create incomplete/false data. This data is purely incomplete.
7. Consistent
Data must be consistent, chronologically arranged in appropriate time frame. Data should be record in in such way that any audit can rely on it. GDP practice is the best way to record the data. Series of data that is chronologically organized define the data is more consistent and reliable. A reliable data can face any type of GMP audit due to it provides best data integrity.
Most of the pharma company face serious non-compliance at regulatory audit for data integrity. If your firm confirm data integrity then you can create best GMP culture at your firm. To maintain data integrity is the prior conditions of the cGMP.
8. Enduring
All type of material is not suitable for data recording, specific paper to be introduce for specific data recording. Data to be record in such material that it can be traceable after a period of time. Generally long lasting material use for data recording. You should take care about readability of data after a specific period of time based on its impotence.
Usually better quality paper use to record validation related document as its last till company life. Regular uses document like batch production record may be record in general usage paper as its last maximum 3 to 5 years including shelf life plus one year.
Document subject to destruction, proper recording to be marinated as it can be easily teachable. Approval must be taken before proceeded any type of destruction related activities.
9. Available
Data should be kept in a specific place where you can easily find it or it is available as when required. It should be keep in a secure place and access must be limited. List of personnel must be define to access the specific area. Data plays an important role when any organization want to take any decision based on previous history. By this time you have to make it available on that time so you have to keep it in right place. All type of future reference backed by data history so you must pay attention to secure your data.
This all about ALCOA and ALCOA Plus