![]() Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data. Metadata is often described as data about data. A data value is by itself meaningless without additional information about the data. ![]() Metadata may be defined as the contextual information required to understand data. The data shall be well supported by the metadata. The language used shall be consistent and straightforward. Confusing and long sentences shall be avoided. Often, we encounter problems reading ‘O’ and ‘0’, ‘l’ and ‘1’ etc.Īpart from writing or recording properly, care shall be taken while writing the sentences. However, care should be taken while deciding on the fonts and font sizes for electronic systems. Such problem is not normally encountered with the electronically generated data. LEGIBLE: Legibility means that the data recorded shall be clear to read, especially where the data is being recorded manually. An audit trail should capture user identification (ID), date and time stamps and the electronic signature should be securely and permanently linked to the signed record. In electronic records, this could be done through the use of unique user logons that link the user to actions that create, modify or delete data or unique electronic signatures which can be either biometric or non-biometric. In paper records, this could be done through the use of initials, full handwritten signature or a controlled personal seal. Even the changes made to any records shall be attributable. It’s also important to record the date of the collection or generation of data. Principles of ALCOA and ALCOA+ are as follows:ĪTTRIBUTABLE: The word attributable means that the record generated whether manually or electronically shall be traceable to the person or the machine used to performed the task. failure to adequately review and manage original data and records.įollowing various principles of ALCOA and ALCOA+ shall ensure the integrity of the data being generated.inappropriate and inadequate control of data flow and.the use of computerized systems that are not capable of meeting regulatory requirements or are inappropriately managed and validated.reliance on inadequate human practices.The major reasons for these types of observations are: data integrity, documentation and record management practices. In past few years, FDA and other regulatory agencies have given numerous observations w.r.t. ![]() System design and controls should enable easy detection of errors, omissions, and aberrant results throughout the data’s life cycle Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).ĭata integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. This often leads to failure of regulatory inspections and develop a relation of distrust which is difficult to recover if not impossible.ĭata integrity refers to the completeness, consistency, and accuracy of data. Any issues observed with respect to data integrity may lead to breach of trust between the assessor and assessee. The data presented shall comply with all the basic principles of ALCOA and ALCOA+. USFDA, MHRA, WHO or any other regulatory agency when inspecting an offshore manufacturing premises expects that the data presented to them shall be reliable and trustworthy. It does not store any personal data.Against the backdrop of globalization, especially in case of pharmaceutical industry, data integrity has become one of the basic expectations that a regulator expects from a manufacturer. The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. ![]() The cookie is used to store the user consent for the cookies in the category "Performance". This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other. The cookies is used to store the user consent for the cookies in the category "Necessary". The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". The cookie is used to store the user consent for the cookies in the category "Analytics". These cookies ensure basic functionalities and security features of the website, anonymously. Necessary cookies are absolutely essential for the website to function properly.
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