Alcoa Data Integrity Examples

Data collected and uploaded to TDP undergoes checksum assessments to verify data integrity. Our agents and connectors interrogate the size, shape, and data type of an incoming file or data package. Upon ingestion into TDP, the values are compared against those scanned, retrieved, or generated locally.

Understanding ALCOA. ALCOA is an acronym coined by the office of the US Food And Drugs Administration in the 1990s. It is a set of guiding principles for ensuring Data Integrity and acts as the cornerstone of Good Documentation Processes GDP. The principles apply to both electronic and paper-based data.

The acronym ALCOA has been around since the 1990's, is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice GDP. ALCOA relates to data, whether paper or electronic, and is defined by US FDA guidance as Attributable, Legible, Contemporaneous, Original and Accurate.

For example, ALCOA is mentioned in both the FDA's 2013 Guidance for Industry Electronic Source Data In Clinical Investigations, and the FDA's 2018 Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance For Industry. The 2017 ISPE GAMP Guide Records and Data Integrity has a section on ALCOA

Data Integrity Definition quotTheCompleteness, consistency, and accuracy ofdata. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate ALCOAquot. Data Integrity is defined by the FDA new quotDraft Data Integrity and Compliance Guidance for Industryquot as Data

has gone further with ALCOA ALCOA plus to recommend that data is also Complete, Consistent, Enduring, and Available. With many data acquisition options on the market, it is important to recognize the business risks related to a lack of data integrity, and poorly designed data management systems. Appreciating why ALCOA has been introduced

Over time, the concept of ALCOA Plus has been adopted by various industries, as a framework for ensuring that data security and integrity data protection are observed and maintained. ALCOA Plus has been implemented and is in use by various big bodies, such as the FDA, WHO, and GAMP. ALCOA is all about data quality.

ltp data-pm-slicequot1 1 quotgtThis article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A Attributable.ltpgt

If any Data integrity issues are found, regulatory bodies take action because of violations. Action may be includes warning letters and holding of import. The recently large number of warning letters issued by regulatory is related to Data integrity issues. The international regulatory authority is more concerned about Data integrity issues.

Data integrity can be thought of as a component of a larger process ensuring the security, traceability, and quality of an organization's results over their whole lifecycle. The principles outlined in ALCOA, ALCOA, and ALCOA support efforts toward data integrity and include ensuring that data is attributable and traceable, among others.