GOOD DOCUMENTATION PRACTICES
ALCOA / ALCOA+ Fair Principles
Attributable - All paper and electronic data must be attributable to the person generating the data including who performed an action and when. Attributable can be accomplished by recording manually by initialing and dating a paper record or by audit trail in an electronic system.
Legible - All paper and electronic data must be legible and permanent. Ensuring records are legible and permanent assists with its accessibility throughout the data lifecycle including the storage of paper and electronic data.
Contemporaneous - Contemporaneous means to record the paper or electronic data at the time it is performed. Date and time stamps should flow in order of execution for the data to be credible. Data should never be backdated, or forms completed with expected results prior to execution.
Original - Original data is the paper or electronic medium in which the data point is initially recorded including protocol, form, notebooks, spreadsheet, database, or software application. Understanding where the original data is generated to ensure content and meaning are preserved.
Accurate - For paper and electronic data to be accurate, the data should be free from errors, complete, truthful, and reflective of the observation. Editing should only be performed by using the principles of GDPs.
CCEA
Complete - All paper and electronic data including original test results and repeat test results must be properly recorded clearly identifying the person performing the test as well as when the test was performed.
Consistent - The data’s sequence of events should be in the expected sequence of operations and appropriately date or time stamped to demonstrate the data are contemporaneous.
Enduring - Paper and electronic data are appropriately recorded in laboratory notebooks or invalidated software systems including spreadsheets and databases.
Available - Paper and electronic data are required to be readily available for review, audits, or inspections for the required lifetime of the record. Paper and electronic data should be clearly indexed and/or appropriately labeled to facilitate retrieval.
OAIS
OAIS The Reference Model for an Open Archival Information System (OAIS) was developed for use in facilitating a broad, discipline independent, consensus on the requirements for an archive or repository to provide long-term, preservation of digital information. It was also intended to support the development of additional digital preservation standards.
ALCOA / ALCOA+
FINDABLE
Be able to find your data! By using rich metadata and keywords you can run your system appropriately with a searchable resource.
ACCESSIBLE
Be able to find your data! By using rich metadata and keywords you can run your system appropriately with a searchable resource.
INTEROPERABLE
Use a formal, accessible, shares and broadly applicable language for knowledge representation.
REUSABLE
Reusability is the one of the most critical things. Use a plurality of acccurate and relevant attributes and make the data available to use!
More about ALCOA and Alcoa+
ALCOA and ALCOA+ Differences
ALCOA and ALCOA+ are important principles for ensuring data integrity, but they have some differences.
ALCOA represents the original five principles of data integrity: data should be attributable, legible, recorded in real-time, original, and accurate. It serves as a framework for generating and documenting data in regulated industries.
On the other hand, ALCOA+ expands on the ALCOA principles. It includes the original five principles and adds four more: data should be complete, consistent, enduring, and available. These additional principles address the need for data to be comprehensive, uniform, accessible over time, and easily retrievable.
To sum up, ALCOA provides the core principles of data integrity, while ALCOA+ builds upon them by incorporating extra principles that tackle emerging challenges in data management and regulatory compliance. By embracing both sets of principles, organizations can establish a strong foundation for maintaining data integrity throughout its lifecycle.
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