Maintaining data integrity
Alignment to data management best practice approaches such as ALCOA and FAIR.
The importance of data integrity
Data integrity in life sciences is about much more than just checking files.
For compliance purposes, the eTMF must be checked down to document level. Whereas standard backups are unable to detect corruption, digital preservation solutions can run automatic checks on each file individually to identify issues that need to be addressed.
But there’s more to data integrity than checking files…
Ensuring the integrity of your clinical data is crucial for many reasons, including:
- To enable interrogation
- Prove the science of the research you have conducted
- Provide robust evidence behind the research findings
- Enables appropriate decisions to be made. If data is untrustworthy, inaccurate, unreliable (etc.) inspectors are unable to verify/interpret data to organisations that secure marketing approval.
Conforming to best practice principles like ALCOA supports the integrity of your data.
Best practice approaches to data management: ALCOA+
As life sciences organisations are becoming big data enterprises there is a clear need to implement good long-term data management practices.
The ALCOA principles are used as the basis for measuring and reporting on data integrity compliance. It’s also worth noting that these principles can also be referred to as ALCOA+ and ALCOA-C.
These principles generally apply across the board for good data management but they have particular relevance to the life sciences industry, with many of the principles being referenced in both FDA and EMA regulations as well as GxP guidelines.
The key principles of ALCOA+ are:
Attributability: Who acquired the data or performed an action and when?
- Legibility: Can you read the data and any entries?
- Contemporaneous: Documented at the time of the activity.
- Original: A written printout or observation or a certified copy thereof.
- Accurate: No errors or editing without documented amendments.
- Complete: All data including any repeat or reanalysis performed on the sample.
- Consistent: All elements of the analysis such as the sequence of events follow on and are date or time-stamped in the expected sequence.
- Enduring: Recorded in notebooks or electronic media in the data systems of instruments.
- Available: Can be accessed for review and audit or inspection over the lifetime of the record.
“Electronic records are managed in a validated system to ensure records are stored and maintained by ALCOA standards and are ready for retrieval in human readable form and electronic form. Access to records can be limited by individual and by level of access.”
FDA 21 CFR Part 11
Best practice approaches to data management: FAIR
An alternative option would be the FAIR data principles which were created to support further scientific study through good data management.
The key principles of FAIR data are:
- Findable: Metadata and data should be easy to find for both humans and computers.
- Accessible: Once the user finds the required data, they need to know how to access that data.
- Interoperable: The data usually needs to be integrated with other data. In addition, the data needs to interoperate with applications or workflows for analysis, storage, and processing.
- Re-usable: The ultimate goal of FAIR is to optimise the reuse of data. Metadata and data should be well-described so that they can be replicated and/or combined in different settings.
When we look at clinical studies there can be numerous partners that an organisation is working with to generate all the data needed for their specific study. The need to implement FAIR principles is paramount to being able to re-use the data generated.
Adhering to FAIR ensures that stakeholders can find and access the data they need.
The combination of both sets of principles (ALCOA+ and FAIR) can provide the foundation that life sciences organisations can build upon to ensure good data management and compliance, with proper data archival and preservation practices key to any successful implementation.
Services Product Blog & News About Us
Arkivum, a world leader in digital archiving and preservation, guarantees the past, present, and future of valuable data. Expert and meticulous in handling data and digitised assets in large volumes and multiple formats, Arkivum offers a fully managed, end-to-end service that streamlines complex workflows and regulatory processes.
© 2022 Arkivum Ltd. Company Reg No. 07530353 | VAT No. GB107755411