Data integrity is increasingly becoming a critical gmp issue in the pharmaceutical and medical device industry. This new guidance was released in response to a recent influx in data manipulation concerns. Data integrity regulations fda inspects for electronic data integrity during the pre and postmarket product approval process under 21 cfr part 11, which is commonly referred to as the data integrity regulation. When you have this, you have data you can use and rely on. Addressing data reliability issues 189 references and further reading 190 appendix 1 expectations and examples of special risk management considerations for the implementation of alcoa plus principles in paperbased and electronic systems 192. Elm10201 the enduring assets of a laboratorys work are the records that document those activities. The term alcoa is an acronym, which stands for attributable, legible, contemporaneous, original and accurate. Fda draft guidance on data integrity in april 2016, the fda issued draft guidance for industry on data integrity and compliance with cgmp 4. Data integrity alcoa berkaitan dengan data, apakah dalam bentuk rekaman kertas atau elektronik, dan didefinisikan oleh panduan fda as sebagai atributable, legible, contemporaneous, original and accurate. Conclusions data integrity enables good decisionmaking by pharmaceutical manufacturers and regulatory authorities. Mar 10, 2018 mhra data integrity definitions and guidance data integrity is the extent to which all data are complete, consistent and accurate throughout the data lifecycle. Organizations have been utilizing validated computerized systems for years. In recent years, infractions relating to data integrity have been noted in several food and drug administration fda warning letters, but it is not a new concept. The acronym alcoa has been around since the 1990s, is used by regulated industries as a framework for ensuring data integrity, and is key to good documentation practice gdp.
Alcoa is an acronym for the original five principles of data integrity. Data integrity, alcoa, warning letter, 21 cfr, audit trails. Data integrity is critical throughout the cgmp data life cycle, including in the creation. Assurance of data integrity is a component of the larger category of data management and applies equally to paper records and electronic records. Mhra data integrity guidance, march 2018 presented by philip butson, 15nov2018 principles riskbased approach dira. Many of the concepts for alcoa have been captured in the regulations as far back as 1978. Alcoa stands for attributable, legible, contemporaneous, original and accurate is a technique that can help ensure paper and electronic data. Alcoa alcoa is an acronym used by the fda that stands for attributable, legible, contemporaneous, original, and. Attributable, legible, contemporaneous, original and accurate is a technique that can help ensure paper and electronic data are compliant with fda regulations and. The extent to which all data are complete, consistent and accurate throughout the data lifecycle from initial data generation and recording through processing including transformation or migration, use, retention, archiving, retrieval and.
Electronically recorded data recorded using equipment that ranges from simple machines through to complex and highly configurable computerised systems. However, in recent years, regulators have found that these organizations are falling short when it comes to maintaining adequate data integrity within. Fda and other regulatory authorities expect that data will have attributes described in the acronym alcoa. The principles within this guide are applicable for all stages throughout the product lifecycle. The four key principles of data integrity are highlighted in the following sections. Data integrity means that all the steps defined above are well managed, controlled and documented and therefore the records of the activities follow the alcoa principles described in the guidelines. Guideline on data integrity world health organization. From alcoa to alcoa plus data integrity pharmastate.
Data integrity for the fda regulated industry fda warning letters issued for data integrity issues are on the rise. During inspections a multitude of problems being found by the pharmaceutical regulatory agency because poor practices. Complete,consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy and accurate alcoa. A normally used word form for attributable, legible, contemporaneous, original and accurate the descriptor alcoa has been around since the 1990s ensuring. Alcoa is used by regulated industries as a framework for ensuring data integrity and is essential to ensuring good documentation practices gdps.
Woollen from the fdas office of enforcement in the 1990s. Alcoa defines good data integrity practice as creating records that are attributable to the. It has an audit trail function that tracks all changes made to a spreadsheet. Data integrity alcoa limits its collection of personal data to that which is relevant for the intended business and legal purposes. That is why it is important to implement the alcoa principle and make the data infrastructure an asset, instead of it being a liability. Alcoac can be described as an insightful checklist, which is part of the official 21 code of federal regulations cfr 58. Anyhow, in this article, we look at the data integrity more from the calibration process point of view, and focus mainly on the pharmaceutical and. Data integrity is an important current issue for regulators around the world. In their 2003 guidance on the implementation of their 21 cfr part 11 data integrity rule, the fda use the acronym alcoa, where they define good data integrity practice as creating records that are attributable to the technician carrying out the testing, are legible, are created contemporaneously, original and accurate. Information derived or obtained from raw data, for example a reported analytical result mhra, 2015 data integrity. Highlights data security and integrity should be perceived as a process rather than a onetime factor. Alcoa data integrity is used by industries because it ensures that data attain the.
As a concept, data integrity is by no means a new one, it has been around for several decades. Data errors can seriously affect both small and big companies. Data integrity and compliance with cgmp guidance for. Changing from automated or computerised systems to paperbased manual systems or. Data integrity and compliance with drug cgmp questions and. The importance of recordkeeping in drug manufacturing can be seen as far back as 1938, when the. This is also known as the alcoa principle guiding data integrity. The extent to which all data are complete, consistent and accurate throughout the data lifecycle from initial data generation and recording through processing including transformation or migration, use, retention, archiving, retrieval and destruction. Data integrity means data such as from personnel or environmental monitoring that is accurate, complete and repeatable, which in turn ensures the products quality and public safety. A static record format, such as a paper or pdf record, is one. Failure to maintain data integrity compromises a companys ability to demonstrate the safety and efficacy of its products. To add to those concerns, even the term data integrity can have widely differing meanings or interpretation, and there are currently few definitive reference sources available on the subject. Ofni systems excelsafe is used to control and monitor changes made to spreadsheets. Alcoa attributable, legible, contemporaneous, original, accurate principles and eu expectations can be found here for api and fp.
Research article overview of data integrity issues in the. Fda warning letters issued for data integrity issues are on the rise. Assuring data integrity in the life science industry. An official definition of data integrity is not found in the regulations. Alcoa data integrity is used by industries because it. Attributable, legible, contemporaneous, original and accurate. Eu privacy shield privacy notice alcoa corporation alcoa recognizes and respects the privacy rights of individuals with regards to personal data.
Complete, consistent, and accurate data should be attributable, legible, and contemporaneously recorded, original or a true copy, and accurate. For computerised systems, manual interfaces with it systems should be. Emas guidance on data integrity indian pharmaceutical alliance annual congress mumbai, india presented by brendan cuddy on 23 24 february 2017 head of manufacturing and quality compliance, european medicines agency. Data integrityrelated cgmp violations may lead to regulatory. Data integrity refers to the completeness, consistency, and accuracy of data. Data integrityrelated cgmp violations may lead to regulatory actions, including warning letters, import alerts, and consent decrees.
Collectively these arrangements fulfil the concept of data governance. Fda cgmp inspections have uncovered violations with data integrity issues. Data integrity as per medicines and healthcare products. It has been implemented in medical practices in order to ensure confidentiality, credibility, accuracy, and validation. It is expected to consider not only a computerised system but also the supporting people, guidance, training and quality systems. Data integrity and data management for gxp regulated firms. As mentioned above, alcoac is the leading guidance that helps researchers and audits. Data integrity, alcoa, regulatory body, usfda, 21cfr. Introduction ata has never been easy to manage as it contains various steps right from generation to destruction.
Data integrity is key in a pharmaceutical quality system ensuring that products are of the desired quality. Escalation of serious regulatory actions related to data integrity violations has prompted the need to assess data integrity compliance and implement systems designed to guarantee it. Alcoa is an abbreviation which stands for attributable, legible, contemporaneous and accurate. Data lifecycle and risk management data governance. This acronym was first referenced in the september 20 guidance for industry, electronic source data in clinical investigations and. Fda published the first guideline in 1963, and since then fda and european union eu have published numerous guidelines on various topics related to data integrity for the pharmaceutical industry. Data integrity is an important component of industrys responsibility to ensure the safety, efficacy, and quality of drugs, and of fdas ability to protect the public health. This focus on the history of data integrity represents an evolution over the past 30plus years and addresses both changes in technology and learning from gmp inspections.
Data integrity is a high profile issue in the life science industry globally, partly as a result of enforcements, overseas inspections and criminal prosecutions instigated by fda, mhra and other european regulatory authorities. Data integrity risk assessment map processes identify. Managing data and records throughout the data life cycle 186 12. Klik link berikut ini untuk informasi lebih lanjut. Data integrity for the fda regulated industry quality systems. Assuring data integrity in life sciences ideagen plc. Alcoa stands for attributable, legible, contemporaneous, original and. Some key concepts of gdocps are summarised by the acronym alcoa. Regulatory environments data integrity principles alcoa principles basic data integrity expectations data integrity examples and wl implementation 3. The food and drug administration fda or agency is announcing the availability of a final guidance for industry entitled data integrity and compliance with drug cgmp. A harmonized approach to data integrity bioprocess. 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 is observed and maintained.
Data integrity is defined as, the completeness, consistency, and accuracy of data. Data integrity and compliance with drug cgmp questions and answers. The purpose of this new draft guidance is to ensure data integrity in the pharmaceutical industry through. Practical riskbased guide for managing data integrity. The fda recommends typical formats such as pdf, xml or sgml. Review of good data integrity principles ofni systems. Organisational influences on successful data integrity management. Assuring data integrity in the life science industry data integrity is a high profile issue in the life science industry globally, partly as a result of enforcements, overseas inspections and criminal prosecutions instigated by fda, mhra and other european regulatory authorities. Electronically recorded data recorded using equipment that ranges from simple machines through to complex and. Principles of data integrity and good documentation practices.