{"id":234,"date":"2018-08-27T14:14:54","date_gmt":"2018-08-27T14:14:54","guid":{"rendered":"https:\/\/www.pharmity.com\/?p=234"},"modified":"2019-11-12T15:34:52","modified_gmt":"2019-11-12T15:34:52","slug":"data-integrity-how-to-implement-an-effective-audit-trail","status":"publish","type":"post","link":"https:\/\/www.pharmity.com\/staging\/?p=234","title":{"rendered":"Data Integrity – How To Implement An Effective Audit Trail"},"content":{"rendered":"

\"DataMaintaining an audit trail is a regulatory compliance requirement, but what makes a good audit trail that is effective and complies with regulations? <\/strong><\/span><\/h4>\n

This article will explain what and audit trail is, what the applicable regulations are and the main aspects to consider when implementing an audit trail to contribute to safeguard clinical data integrity.<\/span><\/strong><\/h4>\n

<\/p>\n

Acceptance of data from clinical trials for decision-making purposes depends on the Regulatory Authorities\u2019 ability to verify the quality and integrity of the data.<\/span><\/p>\n

Data integrity has become a major priority during regulatory inspections and <\/span>audit trail<\/b><\/span><\/span> deficiencies in particular have been cited in a growing number of observations.<\/span><\/p>\n

EU GMP Annex 11, 21 CFR Part 11 and related guidance documents outline the current regulatory requirements for audit trails. <\/span><\/p>\n

ICH GCP defines audit trail as <\/span>\u201cDocumentation that allows reconstruction of the course of events\u201d<\/i><\/span>1<\/span><\/sup>.<\/span><\/p>\n

The basic definition of an audit trail is a log that contains metadata concerning when and by whom data has been originally entered, changed, or deleted<\/span>2,3<\/span><\/sup>.<\/span><\/p>\n

The MHRA guidance on GXP Data Integrity published in March 2018 also covers the Audit Trail topic:<\/span><\/p>\n

\u201cThe audit trail is a form of metadata containing information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the <\/i><\/span>\u201c<\/i><\/span>who, what, when and why<\/b><\/i><\/span><\/span>\u201d<\/i><\/span> of the action<\/i><\/span>\u201d<\/i><\/span>4<\/span><\/sup>.<\/i><\/span><\/p>\n

The decision whether to apply audit trails for electronic records should be based on a combination of GXP regulatory requirements and <\/span>assessment of risk<\/b><\/span><\/span> to the <\/span>trustworthiness<\/b><\/span><\/span> and <\/span>reliability<\/b><\/span><\/span> of records<\/b><\/span><\/span>, including the risk of unauthorized or undetectable changes to records<\/span>5<\/span><\/sup>, and the determination <\/span>of the potential effect on <\/span>product quality<\/b><\/span><\/span>, <\/span><\/span>safety<\/b><\/span><\/span> and <\/span>record integrity<\/b><\/span><\/span>6<\/b><\/span><\/sup><\/span>.<\/span><\/p>\n


\n“The need for and the type of audit trails should be based on a documented and justified risk assessment”<\/b><\/span>7
\n<\/b><\/span><\/sup><\/p>\n


\n\"DataWhile many regulated companies understand the importance of configuring their computer systems to ensure audit trails are adequate and meet regulatory requirements, many others still struggle to maintain electronic records with a complete and compliant audit trail.<\/span><\/p>\n

There are many things that should be taken into consideration when setting up audit trails. Many of the controls will be technical in nature and will form part of the functionality of a purchased system; however, a combination of technical and procedural controls may be needed for an adequate level of protection<\/span>7<\/span><\/sup>. <\/span><\/p>\n

Whether companies are using a solution that is custom made or they acquire off-the-shelf software from a supplier, they need to consider the following topics:<\/span><\/p>\n