Data Integrity Principles few important considerations : ALCOA and ALCOA+
Data integrity principles referenced in the MHRA guidance includes the following criteria’s:
The company management culture should ensure that data is accurate, legible, complete and accurate in both paper and electronic forms.
Moving from computerized or laboratory management systems (LIMS) to paper-based manual systems or vice versa does not change the data integrity principles; they were to be followed by the organization following ALCOA+ principles.
If any data integrity weaknesses or threat’s are identified, organization should suffice that necessary corrective and preventive actions (CAPA) were implemented across all relevant activities and systems (it should be applied for both network based and stand alone systems).
ALCOA has been introduced by FDA while ALCOA+ concept has been introduced by European MHRA. “ALCOA+”. While the FDA’s draft guidance introduced the concept of ALCOA, or data needing to be Attributable, Legible, Contemporaneous, Original, and Accurate, the MHRA guidance references “ALCOA+” which includes the additional concepts of the data being Complete, Consistent, Enduring and Available.
In certain cases reduced effort and/or frequency of control measures may be justified for data that has a lesser impact to product or patient;
All systems and processes in manufacturing or quality control laboratory should be designated in a way that will facilitate compliance (cGMP/cGLP) and data integrity principles.
Accessibility and availability to blank paper formats for raw/source data recording should be appropriately controlled and monitored. All blank formats issued by quality assurance department should be appropriately numbered and should have format number and should be monitored by issuance register. Use of controlled books with numbered pages, may be necessary to prevent the re-creation of a record;
The use of scribes to record activity on behalf of another operator can be considered where justified. In this case, the recording by the second person should be equally competent with the task being performed, and the records should clearly validate both the person performing the task and the person completing the record (person who have completed the documentation).
Raw data can only be excluded where it can be demonstrated through valid scientific justification that the data are not representative of the quantity measured, sampled or acquired. In all cases, this justification should be documented and considered during data review and reporting.
All Raw data (even excluded data) should be stored with the original data set, and should be available for review for auditing agencies in a readily available format (PDF, Word) and hard copies.
Organizations should be able to demonstrate to auditing/Regulatory agencies the access levels granted to individual staff members (persons who does the bench work) is restricted, further he does not admin functionalities and further guarantee that historical information regarding audit trials user access level is available on request by auditing agencies. (updated on 13/11/2020)