The data integrity has turned into an intense issue which is bringing association a terrible name during regulatory inspection. The administrative body trusts that the organisation where the information is precise, reliable and accurate and follow the regulatory guidelines and SOPs are working legitimately.
The data integrity is characterised as " the degree to which all information are finished, accurate and precise"
The administrative body anticipate that the duty regarding data management and data integrity lies with the manufacturer experiencing investigation. It is their obligation to check loopholes in their organisation and guarantee that date trustworthiness is kept up.
Slips in information respectability are not constrained to misrepresentation, it can be accidental and still cause hazard. Any potential for bargaining the unwavering quality of information is a danger that ought to be recognised and comprehended all together have proper control to be set up.
Data integrity issues can happen at any point of time intentionally or unintentionally, by any employee, so administration should be careful in recognising issues and comprehend purposes for omissions, when found, to empower examination of the issue and execution of corrective and preventive activity.
Management shall regularly monitor all such issues during management review meeting and provide sufficient resources so that such issues may not happen. If any data integrity issues is found internally than it shall be bring to the notice of the management. Such issues may be handles through deviations. The impact shall be assessed on sound scientific ground.
Expectation of regulatory bodies in filled documents
- Personnel shall make on line entries in the documents.
- The entries made by the operating personnel shall be checked and signed by the supervising personnel.
- No entry shall be over written.
- If anything is wrong do not over write it.
- Strike it with a single line and sign near the entry with date and put the correct entry.
- While making corrections, it shall be ensured that the previous entry is still legible.
- Initials are acceptable unless the documents specially require a signature.
- There shall not be any blanks in the formats/documents.
- All the supporting documents which are generated during external agencies validation, calibration activity etc shall be checked/verified by the concerned department personnel/QA department
- All the related documents like weight slips, annexures, appendix, labels shall be traceable to the main document.
- All the relevant documents shall be handed over after completion of the activity to Quality Assurance department.
- The following should be avoided:
- Overwriting of numerical number.
- Whitening / artificial correction of errors/mistakes.
- Wrong calculations.
- Using White tape or white Ink
- Wrong entry of time, temperature, vacuum, pressure or numerical numbers.
- Formulae, symbols that are typed with errors.
14. The practices of making rough entries to be faired subsequently shall be avoided.
15. If a wrong entry is made, it shall be strike off with signature.
16. Record shall be made by the person responsible for an activity.
17. Person filling the record shall be very clearly identified with the Record.