The View of FDA on Data Integrity.

The only tool available for FDA(Food and drug administration) to ensure Identity , Strength and purity of drugs is the data of Drugs so, integrity(Accuracy  , Reliability ) of that data or Data integrity is of utmost importance for FDA .

Need of Data Integrity –

Due to unavailability of data or less data of drugs FDA have faced many consequences Like Thalidomide disaster , Sulfa drugs tragedy, Poisoned Acetaminophen capsules .these disasters led to death of many people in USA and the reason was Lack of sufficient Safety data .

The state of FDA on the subject is so clear that despite of warning letters and import alerts FDA even institutes criminal charges/consent decrees on an organisation or individual involved in data integrity .FDA the regulatory agency of USA(United states of America) after many amendments made 21-CFR and added Data integrity as a clause in subpart J .

How to achieve  …..

• Attributable –              It should be clear who recorded the data
• Legible –                       Data should be clear and easy to read
• Contemporaneous –  Data entry should be done at the time of activity
• Original –                    Data should be original
• Accurate –                   Data should be accurate and without                                                               manipulation
• Complete –                  Data should be complete .
• consistent –                 Data should be consistent
• Enduring –                  Data should last for a period of time .
• Available –                  Data should be available whenever asked to get it .

If all these points are present in data according to 21 CFR(Code of federal regulation) we can be clear that integrity of data have been achieved in the document .