Data Integrity and FDA Terminologies..

It is well said that data without integrity is just numbers and letters  .FDA(Food and drug administration) expects from pharmaceuticals that the data they have generated is reliable and accurate .In recent years FDA have observed many data integrity issues across the globe many warning letters have been issued  to curb data integrity FDA have also issued guidance on data integrity .

21 CFR(Code of Federal regulations) provides us with flexible system to manage data . Risk management system has also been given to look into data integrity issues . In  21 CFR Schedule J regulations have been issued by FDA on data integrity .

• 211.68         Backup of data exact and complete
• 212.110       Data to be stored and prevent deterioration
• 211.100       Contemporaneous data(At the time of activity)
• 211.180       Original records

Terminologies FDA uses with respect to data .

• Metadata  is an information required to understand the data example 10 is just an number without metadata Kg in some casesmetadata is Date , Stamp , Time , Instrument ID etc . According to 21 CFR 211.188 and 211.194 Data should be maintained along with metadata throughout the retention period to Reconstruct the cGMP activities .
• Audit trail is an computer generated record with time stamp which assures .When  cGMP activity occurred,Who performed cGMP activity ,What cGMP activity have been performed ,Why cGMP activity have been performed .Thus Audit trail helps in reconstruction of cGMP activity performed .
• Static and dynamic Data  Static data means Fixed data such as data reconstructed on paper or image. Dynamic data means interaction between user and record example In compression machine when compressing force is increased the thickness of tablet decreases and consequently record changes .
• Backup  FDA refers to Backup in 211.68 as true copies of original data must be maintained throughout the retention period .