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ALCOA & ALCOA+ Data Integrity

DATA+INTEGRITY = DATA INTEGRITY
ALCOA+ Data Integrity

ALCOA was a tool to implement the data integrity but ALCOA+ made this tool more powerful and sharp.ALCOA is stands for Attributable,  Legible, Contemporaneous, Original and Accurate but ALCOA+ is additional of a few more concepts which are Complete, Consistent, Enduring and Available.
ALCOA+ has been implemented and is in use by various big bodies such as the FDA, WHO, GAMP (GAMP=Good automated manufacturing practice).  

Data:

  1. Fact and statistics collected together for reference or analysis.
  2. Thinking known or assume as facts, making the basis of reasoning or calculation.

Integrity:

  1. The quality of being honest and having strong moral principles.
  2. The state of being whole and undivided.
EXAMPLE OF GDP CORRECTIONS
  1. Writing errors
  2. Grammatically mistake
  3. Typographical errors
  4. Transcription errors
  5. Calculation errors etc.

EXAMPLE OF DATA INTEGRITY ISSUES

  1. Back/Forward dating/Timing
  2. Time and date manipulation
  3. Unauthorized access
  4. Alteration of raw or original data
  5. Multiple analysis without justification 
  6. Providing passing result without testing
  7. Re-use of controlled document number
  8. Falsification of batch records for getting clean records
  9. Unofficial trail of sample etc

ALCOA+

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate                                                                                                          
  • Complete
  • Consistent
  • Enduring
  • Available

Attributable:

  1. Who has done, checked, verify, review, approve.
  2. Data should be easily identified to the person who did the data collection, place of origin and the time of data collection.

Legible:

  1. Legible data means the data can be easily read for the short and long term.
  2. The data must be legible.
  3. The records should be permanent.
  4. Use indelible ink, Signal line cut and sing, do not use whitener and do not overwrite.
  5. Prepare permanent copy of fade-able data (Printout that may fade away)

Contemporaneous:

  1. Data must be recorded in real time as and when it occurred.
  2. Any practical must be according to written procedure.
  3. Data or Testing that is performed electronically should have a date/time stamp attached to the records

Original:

  1. Data must be preserved in its unaltered state according to written procedure.
  2. Raw data shall be kept along with its final reports.
  3. Data should be entered on original or true copy (Controlled/issue copy)
  4. Ensure validation test result are recorded on the approved protocol/reports
  5. Recording result in a notebook for transcription later can introduce errors.
  6. If your original data in hand written and need to be stored electronically, ensure a true copy is generated, the copy is verified for completeness and then migrated into the electronic system.

Accurate:

  1. It should be error tree.In the case of any amendment, there should be accompanying documents to support the change.
  2. Data must correctly, reflect the actual observation.
  3. There should be no editing or errors correction without document and approval.

Complete:

  1. Exp. A batch production records must contain all related information i.e. Weight/sterilization/depyrogenation printout, incident, deviation details along with it.
  2. A qualification documents must contain related records printout with its.
  3. A process validation records must contain protocol, reports, batch records, testing records, results etc. with it.

Consistent:

  1. Good documentation practices should be applied throughout any process, without exception, including deviation, change control, incidents that may occur during the process. This includes capturing all change made to data.

   Enduring:

       Data entries are storage on media proven for records retention period.

   Available:

       Data entries are readily accessible in human readable format when needed.

Data Integrity as per 21 CFR Rules 

21 CFR has rules of data integrity its part 11 has every thing about electronic data digital signature. Clarifying the method under which electronic records as well as signature are taken to be accurate, valid, reliable, confidential and equal proportion to the paper records and signatures written by hands.The aim of part 11 of 21 CFR Rules is to promote the integrity of the usage of electronic records and signature such that the data is not distorted, deleted, or manipulated in any way. Furthermore these rules ensure that the relationship between data records is maintained. The maintenance of data relationship is impotent in that it will enable you to retrieve information from various sources.     

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