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May 2, 2024 · Learn what ALCOA and ALCOA Plus mean and how they are applied in pharmaceutical manufacturing to ensure data quality and reliability. Find out the nine components of ALCOA Plus and their definitions, examples and FAQs.
- ALCOA Principles of Data Integrity : Pharmaguideline
Data integrity is protection of data from unauthorized and...
- ALCOA in Pharmaceuticals : A necessary tool for Quality
ALCOA in pharmaceuticals is used to ensure that the quality...
- ALCOA Principles of Data Integrity : Pharmaguideline
Learn about the key aspects of data integrity in Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations, such as ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate). See the origin, definition, and examples of data types and data flow in the pharmaceutical industry.
- Attributable Meaning in Alcoa Plus
- Legible Meaning in Alcoa Plus
- Contemporaneous Meaning in Alcoa Plus
- Original Meaning in Alcoa Plus
- Accurate Meaning in Alcoa Plus
- Complete Meaning in Alcoa Plus
- Consistent Meaning in Alcoa Plus
- Enduring Meaning in Alcoa Plus
- Available Meaning in Alcoa Plus
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A: Attributable –This principle ensures that data is linked to its source and allows for traceability. It helps to answer the question of who is responsible for generating or modifying the data. When recording the documentation, it is important to attribute it to a particular individual. This means including the name of the person responsible for c...
L: Legible –Legibility emphasizes the importance of data being easily readable and understandable. It ensures that information can be comprehend and interpreted without any doubt. Making sure data is easy to read is more than just being able to understand it clearly, although that’s important when keeping records by hand. With electronic data, it’s...
C: Contemporaneous –Contemporaneous means that data should be recorded at the time it is generated or observed. It promotes the accuracy and reliability of data by preventing delayed or retrospective entries. It’s very important to record data whenever something happens or an action is taken. When it comes to electronic data, it’s usually normal to...
O: Original –Originality signifies that data should be the first record or a certified true copy of the original information. It emphasizes the preservation of the primary source without any alterations. It’s better to have original records instead of copies or transcriptions, especially when keeping records manually. For example, if you write info...
A: Accurate – Accuracy is a fundamental aspect of data integrity. It requires data to be correct, free from errors, and consistent with the observed or intended results. All records should show exactly what really happened, and they should be free of mistakes. We shouldn’t edit the original information in a way that makes us lose that information. ...
C: Complete –Completeness ensures that all necessary information is included and nothing is omitted. It prevents partial or fragmented data that could lead to misinterpretation. Every piece of data that is recorded should have a Audit trail that shows if anything has been deleted or lost. This doesn’t only include the main data, but also informatio...
C: Consistent –Consistency requires data to be uniform and coherent across different records and sources. It ensures that there are no conflicting or contradictory pieces of information. Consistency means keeping data in chronological order, with a date and time stamp that follows a logical sequence. If any changes are made to the original data, th...
E: Enduring –Enduring signifies that data should be preserved and maintained throughout its designated retention period. It ensures data integrity over time, allowing for proper historical reference and analysis. ALCOA+ focuses on making sure data is available for a long time, even decades after it’s recorded. This means taking steps to ensure data...
A: Available –Availability emphasizes that data should be accessible when needed. It should be stored securely and retrievable for authorized personnel to support decision-making and regulatory compliance. Data needs to not just exist, but also be easy to find and access. This means having storage systems that allow searching, proper indexing, and ...
Learn what ALCOA Plus means and how it applies to data integrity in pharmaceutical industries. Find out the 9 principles of ALCOA Plus and their definitions, examples, and FAQs.
- Attributable. Each piece of data should be attributed to the person who generated it. This part should include the details of the person who performed the action and when it was performed (a timestamp).
- Legible. All recorded data should be readable (legible) and permanent. The readable part is fairly obvious - the data will be used multiple times by different people and if only one person can read the actual records then the data is more or less unusable.
- Contemporaneous. This means that the data is always recorded at the actual time the action or work was performed. No piece of data should be recorded retrospectively.
- Original. It is very important to have a medium where the data was first recorded. This could be a form or a protocol, a dedicated notebook or a database, doesn't really matter as long as it is preserved in its original form.
Apr 17, 2024 · ALCOA in pharmaceuticals is used to ensure that the quality of the evidence collected is maintained. Many regulatory bodies such as the FDA, Health Canada, and the EMEA recommend the use of ALCOA to ensure good documentation practices in pharmaceuticals.
This document provides guidance for industry on data integrity and compliance with drug CGMP. It covers topics such as data integrity, metadata, audit trail, electronic records, and data validation.
Eurotherm offers data management, acquisition and control solutions to help maintain data integrity in life sciences and biotechnology. Learn how Eurotherm products and services comply with the ALCOA+ principles and meet regulatory requirements.
