ALCOA to ALCOA Plus Plus for Data Integrity in pharma guideline

Attributable

Mainly to ask of following question  is that  Who, when, what and why?

1. Who Person has identified
2. When place has identified
3. What event identified
4. Why mean why all the operation will be happen
5. that all example will give as on QMS activity document

other example whenever during  log book entry is that like(instrument or operational logbook)  or used log book make entry time and date and person signature is also example attribute.

Legible

Document is Readable and permanent?

1. During manually entry in any place like instrument logbook etc might be a possible that document not readable due to analyst, operator etc hand right not proper hence traceability difficult to find out what event occur.
2. If data was not readable might chang data integrity.
3. Error negated due to use software and periodic review all log book

Contemporaneous

Measure factor – At the right time?

• Example same Instrument uses look book after event like kingfisher instrument factor analysis completed and after that do every entry like balances, and instrument uses etc..

Original

Document –  Unaltered state and ‘true copy’?

• Original data and metadata, format, do write .

Accurate

Document right value/action?

• Example Calibration date Real value and performances value is accurate or not etc check

Now time updated to ALCOA++ is that

Complete

Document – Is all information available?

• some time analyst or chemist or supervisor make document forgotten write scope, history, document procedure, method etc during make sop

Consistent

Document sequence correct?

• All topic covered like first title, scope, Responsibility etc go on as your index.

Enduring

Document  securely stored for long term use?

• Some will happen not fixed place document store hence possibility that document missing

Available

Is the data accessible immediately?

• Data meet as timely and easily whenever document required

 

 

Other topic

HPLC ||   Deviation || GMP ||