Organizations have been utilizing validated computerized systems for years. However, in recent years, regulators have found that these organizations are falling short when it comes to maintaining adequate data integrity within their computerized systems. In response to the increasing number of observations related to data integrity made during inspections, a recommendation for the development of new guidance for good data management was put forth at an informal consultation held by the WHO (World Health Organization) in April 2014. Shortly after, the WHO Expert Committee on Specifications for Pharmaceutical Preparations received documents from PQT-Inspections proposing the outline of a new guidance. The goal of this was to consolidate and improve upon the existing principles ensuring data integrity from current good practices and guidance documents.
Attributable data must be recorded so that it can be linked to the unique individual who produced it. Every piece of data entered into the record must be capable of being traced back to the time it was taken and to the individual who entered it.
Legible data must be traceable, permanent, readable, and understandable by anyone reviewing the record. This is expanded to include any metadata pertaining to the record.
Contemporaneous data are data that are summarily entered into the record at the time they are generated.
Original data, or the source data, is the record medium in which the data was first recorded. An original data record should include the first data entered and all successive data entries required to fully detail the scope of the project.
Accurate data are correct, truthful, complete, valid, and reliable. Controls put in place to assure the accuracy of data should be implemented on a risk-based structure.
Attributable: The main controls needed to maintain an attributable electronic record are the use of secure and unique user logons and electronic signatures. Using generic login-IDs or sharing credentials should always be avoided. Unique user logons allow for individuals to be linked to the creation, modification or deletion of data within the record. For a signature to be legally-binding there should be a secure link between the person signing and the resulting signature. The use of digital images of hand written signatures is not often considered a secure method for electronically signing documents. These images lose their credibility when not stored in a secure location or when they appear on documents that can be easily copied by others.
Legible: In order for an electronic record to be considered legible, traceable, and permanent it must utilize controls such as writing SOPs and designing a system that promotes saving electronic data in concurrence with the execution of the activity. This is best done by prohibiting the creation or manipulation of data in temporary memory as well as immediately committing data to a permanent memory before moving on. Secure time stamped audit trails should be used to record operator actions. The system configuration should limit the enhanced security rights of users such as turning off the audit trail or overwriting data. These administrative rights should be reserved (whenever possible) for individuals who are independent of those responsible for the content of the electronic records. Improperly overwriting data or manipulating the audit trail impairs the legibility of the data by obscuring the original value of the record. This is equivalent to the use of single line cross outs in paper records to denote changes to the data. The data in these paper records are changed but the original values must still be legible beneath the cross out mark.
Contemporaneous: Contemporaneous recording of data also utilizes the controls of writing SOPs and maintaining settings that immediately commits data to a permanent memory. In order for the data to be considered contemporaneous the record must also have a secure time stamp system that cannot be altered by users. Time and date stamps should be synchronized across all systems involved in the GxP activity. These controls should be true for both the workstation OS and any relevant software application used. Data is not considered contemporaneous when recorded on an unofficial document and then later entered into the official electronic record.
Original: Original electronic records (or certified true copies) should undergo review and approval procedures. These reviews should describe the review method itself as well as any changes made to the information in the original records. These include changes documented in audit trails or any other relevant metadata. Written procedures should define the frequency, roles and responsibilities, and approach to the review of metadata. A risk-based approach to the scope of these procedures is recommended. Once reviewed, electronic data sets should be electronically signed to document their approval.
Controls should also be put in place to guarantee the retention of original electronic documents as best as possible. The original record should be routinely backed up and stored separately in a safe location in case the original record is lost. Secure storage areas should have a designated electronic archivist who is independent of the GxP operation. Tests should be carried out at times in order to verify that the copy can be retrieved and utilized from secure storage areas.
Accurate: Data accuracy should be maintained through a quality management system that is risk-based and appropriate to the scope of the operation. Routine calibration and equipment maintenance should be performed. Computer systems that generate, maintain, distribute or archive electronic records should be validated. Entry of critical data such as high priority formulas for spreadsheets should be verified by two authorized individuals. Once verified, critical data fields should be locked to prevent modification by any unauthorized individuals.
Written based off the WHO Annex 5 Draft Guidance on Data Integrity