Data Integrity Means: 
- Accurate and reliable data and Information
-Ensuring data trustworthiness and reliability
-The degree to which a collection of data is complete, consistent and accurate
We have To learn what may go wrong which lead to data integrity issues in cGMP. We Will learn phase wise and day to day cases.To understand DATA Integrity let understand requirement and concept Recent regulatory agency observations steer industry to the conclusion that there can be severe penalties for not having data quality that leads to product quality. Data quality may be explained by a simple and straight forward equation: Data Integrity + Data Management = Data Quality. Data quality is mutually dependent on both data integrity and data management.Data management is the process by which we create, control, manage, utilize, and maintain data integrity.Data integrity is the foundation of Data Quality.Conversely, data quality with data integrity but without good data management lacks control of data.Similarly data management without data integrity will lack the elements necessary to have data quality.Data integrity can be expressed in terms of the acronym "ALCOA+” which represents attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.These attributes must be understood and applied to data integrity with good data management. It is only through both that data quality can be achieved. These attributes explained with next time in elaborated manner.
ALCOA:
A = ATTRIBUTABLE
Attributable data linked to the individual who created or recorded the data.
Person’s signature or initials provide attribution to the DATA, that this data recorded, prepared, analyzed or done by, verified by, reviewed by, checked by the individual. In simple words, the data having traceability of the individual who performed the activity.For computerized systems, making data attributable is the utilization of a unique user with an associated private password linked to the individual’s identity.Examples are shared below which leads to data integrity issues
1) The Person/Individual not present in the company however signed the activity on that date.
2) Sharing of Passwords.
3) Generic user Ids.
4) Deletion of Data
5) Different data Folders
6) Individual data files
7) No Audit trail
8)The Computerized system doesn't having control to capture the changes (who, when and why).
9) Entering the Area without having authorization of that Area.
10) User access rights which prevent (or audit trail) data amendments.
11) The use of scribes to record activity on behalf of another operator/Analysts should be considered only on an exceptional basis and only take place where:
> the act of recording places the product or activity at risk, e.g. documenting line interventions by aseptic area operators;
> to accommodate cultural or mitigate staff literacy/language limitations, for instance, where an activity is performed by an operator, but witnessed and recorded by a supervisor or officer
.
L= LEGIBLE
Legible data are clear, concise, and readable. Changes to legible data must not hide or obscure the original record.The data should be understandable, means the raw data shall be write in such a way that it should be easily understandable.
Which activity may Leads to Data Integrity Issues
1)Overwriting.
2)Usage of Fluids, eraser, hiding any written information for unfair means.
3) All Electronic data (raw data, Audit trail) must be able to be reviewed and understood in human readable form.
4) The correct metadata should be linked to each action(for example, Weight prints, pH prints etc.)
C = CONTEMPORANEOUS
Contemporaneous means data must include the date and time of its measurement or action. For computerized systems all data, including metadata, must be related to an action or event.
Which activity may Leads to Data Integrity issues
1) Record data first in unofficial documentation (e.g. on a scrap of paper) and later transfer the data to official documentation (e.g. the laboratory notebook). Instead, original data should be recorded directly in official records, such as approved analytical worksheets, immediately at the time of the GxP activity.
2) It is improper to back date or forward date a record. Instead the date recorded should be the actual date of the data entry. Late entries should be indicated as such. If a person makes mistakes on a paper document he or she should make single-line corrections, sign and date and provide reasons for the changes and retain this record in the record set.
3) Stand-alone computerized systems are provided with full administrator rights to the workstation operating systems on which the original electronic records are stored, this may inappropriately grant permissions to users to rename, copy, delete files stored on the local system and to change the time/date stamp.
4) Difference in time more than ±1 min form the satellite watch to the Clock represents the time in the Instrument/Equipment.
O= ORIGINAL
Original data is the original record or a certified copy.Original data and/or certified true and exact copies that preserve the content and meaning of the original data should be retained as such, original records should be complete, enduring and readily retrievable and readable throughout the records retention period.Original data include original electronic data and metadata in stand-alone computerized laboratory instrument systems.(e.g. UV/Vis, FT-IR, ECG, LC/MS/MS, hematology and chemistry analyzers, etc.), original electronic data and metadata in automated production systems(e.g. automated filter integrity testers, SCADA, DCS, etc.), original electronic data and metadata in network database systems (e.g. LIMS, ERP, MES, eCRF / EDC, toxicology databases, deviation and CAPA databases, etc.), handwritten sample preparation information in paper notebooks, printed recordings of balance readings, electronic health records, paper batch records.
Which activity may Leads to Data Integrity issues
1)Data and document retention arrangements should ensure the protection of records from deliberate or inadvertent alteration or loss. Secure controls should be in place to ensure the data integrity of the record throughout the retention period. Archival processes should be defined in written procedures and validated where appropriate.
2) Data collected or recorded (manually and/or by recording instruments or computerized systems) during a process or
procedure should show that all the defined and required steps have in fact been taken and that the quantity and quality of the output are as expected, enable the complete history of the process or material to be traced and be retained in a comprehensible and accessible form. That is , original records and/or certified true copies should be complete, consistent and enduring.
3) If true copies of original paper records are made by scanning the original paper and converting to an electronic, image, such as pdf, then additional measures to protect the electronic image from further alteration are required (e.g. storage in secure network location with limited access only to electronic archivist personnel, measures to control potential use of annotation tools or other means of preventing further alteration of the copy).
4) Preserving the original electronic data in electronic form is also important since data in dynamic format facilitates greater usability of the data for subsequent processes. For example,temperature logger data maintained electronically facilitates subsequent tracking and trending and monitoring of temperatures in statistical process control charts.
5) Trial Injections of sample.
6) Unauthorized folders in electronic systems in which some GMP data is there.
7)Reprocessing of data without authorization.
In addition to the option of creating certified true copies of original electronic data as verified back-up copies that are then secured in electronic archives, another option to create a certified true copy of original electronic data would be to migrate the original electronic data from one system to another and to verify and document that the validated data migration process preserved the entire content, including all meaningful metadata, as well as the meaning of the original electronic data.
9) Duplicate/repeat analysis without using QMS Investigation and assessment of risk.
A= ACCURATE
Accurate data is correct through the system’s lifecycle. It indicates the same value and its correct meaning. The term “accurate” means data are correct, truthful, valid and reliable.For both paper and electronic records, achieving the goal of accurate data requires adequate procedures, processes, systems and controls that comprise the quality management system. The quality management system should be appropriate to the scope of its activities and risk-based. Controls that assure the accuracy of data in paper records and electronic records include, but are not limited to qualification, calibration and maintenance of equipment, such as balances and pH meters, that generate printouts;Validation of computerized systems that generate, maintain, distribute or archive electronic records;Validation of analytical methods;Validation of production processes;Review of GxP records;Investigation of deviations and doubtful and out-of-specifications results;
Which activity may Leads to Data Integrity issues
1) The entry of critical data into a computer not by an authorized person (e.g. entry of a master processing formula) requires an independent verification and release for use by a second authorized person. For example, to detect and manage risks associated with critical data, procedures would require verification by a second person, such as quality unit personnel, of: calculation formulae entered into spreadsheets; master data entered into LIMS such as fields for specification ranges used to flag out-of-specification values on the certificate of analysis; other critical master data, as appropriate. In addition, once verified, these critical data fields would be locked to prevent further modification, when feasible and appropriate.
2) To ensure the accuracy of sample weights recorded on paper printout from the balance, the balance would be appropriately calibrated and maintained prior to use. In addition, synchronizing and locking the metadata settings on the balance for the time/date settings would ensure accurate recordings of time/date on the balance printout.
3) first data failed specs, retest data passes specs, lab investigations are inadequate or non-existent, but retest data is submitted to the application, anyway.
C = COMPLETE
Complete data includes all data from actions taken to obtain the final result. Complete data includes all metadata generated for each action taken including audit trails.Data management controls need to include procedural controls that ensure that all data are captured and maintained. In the laboratory this data should include all runs -- not just those that passed. The data should not only have the values but also units where appropriate. Procedures must provide the controls when data not used to calculate a final result must be scientifically justified.
C = CONSISTENT
Consistent data shall be created in a manner that can be repeated following a logical sequence of activities based on the method or procedure. Consistency can be defined throughout the lifecycle of data.Procedural controls are essential to successfully creating consistent data. If users are following prescribed methods the likelihood that data can be recreated in a repeatable and consistent manner is much higher. Better efficiencies can often be realized when the method of capture is refined by the users who follow the procedural control on a regular basis.Efficiencies can be built into your process wherein you address multiple data integrity elements simultaneously. For example, time stamps can be used to indicate that adequate time has elapsed to complete process tasks adding both consistent and contemporaneous data integrity elements into a single process.
E = Enduring
Enduring data must be protected from loss, damage, and/or alteration and must be available throughout the defined retention period. Data should be stored on a medium that endures the entire retention period. Data backups should be stored at a different location than the original/raw data. Procedural controls must monitor your data. Confirmation that data can be recovered and read throughout the retention period must be tested periodically as appropriate.
A= AVAILABLEAvailable data are readily retrieved throughout the lifecycle of the system, or the appropriate retention period. Data must be available in human readable form. Considerations must be taken to ensure that data is always available in a timely manner. Procedures must identify how data is stored, where it is stored, and how it can be retrieved. As systems improve, system owners need to ensure that all data are available as systems are upgraded In order to successfully produce good quality data, we must embody the concept that good data quality is an output of both data integrity and data management. The appropriate starting point is to understand and apply the elements of data integrity and implement good efficient data management. It is only through both that data quality can be achieved.
Reference : Data integrity Hand book
