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while working in pharmaceutical industry you  must have heard about someone lost his job due   to the data integrity issue in pharmaceutical  industry every employee should be very very   clear on good documentation practices and alcohol  plus principles data integrity issues are always   unexpected to be get identified by any  regulatory authority like usf diamhra or tga   watch this presentation to be very  clear on alcohol plus principles   and avoiding any kind of data integrity issues   now we will see the what alcoa plus  plus is a stands for attributable   l eligible c contemporaneous or original  a accurate whereas plus plus symbol sign   is given for the complete consistent  enduring and available documentation here we will be seeing the each component in  a detail first we will see the attributable   attributable ensures accountability this contains  a record of who performed the action and when it   was performed the data generated or collected  must be traceable back to the individual   who generated the information you  can see the below example wherein   in a green tick example you can backtrace the  person who has performed the calculation error   the date on which he has performed the  calculation error and what was the previous entry next is legible in simple words the data should  be understandable the term legible traceable and   permanent refers to the requirement that the data  is readable understandable and allow clear picture   of the events in the record so that all the gxp  activities conducted can be fully reconstructed   by the people viewing these records in  the example section you can see the one   non-legible data written wherein it is very  difficult to understand whether the data entry   made is of a number 27 or 29 or anything else the  data must be legible for the entire lifetime of   the document and you must never need to reach out  the author of the document to understand the data this stands for the contemporaries contemporaries  means the online documentation of the real-time   entry contaminants means to record result  measurement or data at the time of the work   is being performed data should not be backdated  or the post dated you can see the below example of   contamination entry variant no back  dating or the post heating is done   the data is entered at the  exact time of the monitoring owing alcohol plus stands for the original in  order to preserve the meaning and indicative   of data the original record should be preserved  meaning the material used should be durable in   the case of duplicates the creator of the original  record should confirm the authenticity of copies in alcohol plus a stands for  accurate the term accurate means   the data is correct truthful complete and reliable now we'll move to the plus part  plus means complete consistent   enduring and available first  we will see the complete   complete means availability of data should be  in the entire form and ensuring that nothing is   excluded or omitted or added intentional  hiding of information shall not be done next is consistent consistent refers to the  reproducibility once the data is generated   it should not get changed during its  lifetime of the tenure once entity is   done and verified in the document like bmr or  bpr it should be same throughout the 10 year   next is engineering entering refers to the  long lasting property of data it is expected   that the data should not get recorded over the  envelope sticking out so the ndrav documents   sap formats are the raw datasheet shall be used  for documentation purpose here it is expected that   the ink that is used for documentation purpose  is having the property that it should not get   faded over the time period and it should be a long  lasting next is available data generators shall   be available whenever required or asked by the  regulatory authorities for the inspection purpose   data should be readily producible and accessible  whenever there is requirement to review the data   thanks for watching videos see left video to know  the different types of materials in pharmaceutical   industry and see right video to know the change  control classification in pharmaceutical industry