Product/Service

GLP Compliance

Source: NextDocs Corporation

Failure to comply with GLPs can result in 483s or warning letters from the FDA, or the equivalent from other regulatory authorities. Furthermore, they can result in the disqualification of a study or even the denial of an IND application.

GLP Audit findings are common and often avoidable. Here, we look at some examples from a 2010 warning letter and discuss how a properly implemented NextDocs system could have helped to avoid these findings.

Issue NextDocs Solution
Testing Facility Management failed to ensure that personnel clearly understand the functions they are to perform [21 CFR 58.31(f)]. NextDocs provides the ability to present employees with documents relevant to their job functions before they become effective, allowing the completion of training activities and certification that an employee has read and understood the document. Training can also include quizzes.
Testing Facility Management failed to implement standard operating procedures (SOPs) in writing setting forth nonclinical laboratory study methods that are adequate to ensure the quality and integrity of the data generated in the course of a study [21 CFR 58.81(a)]. The NextDocs SOP module allows a company’s Quality Assurance group access to the SOPs for a site, department or functional area, as well as insight into their status. Quality Assurance is generally a required approver for all SOPs, allowing them to ensure that adequate SOPs are always in place in a timely manner.
The Quality Assurance Unit failed to determine that no deviations from SOPs were made without proper authorization and documentation [21 CFR 58.35(b)(5)]. The NextDocs QMS module tracks deviations to closure and triggers escalations and notifications for overdue investigations. Deviations are linked to CAPA, which in turn can be linked to document change requests, providing a closed loop.
Study Directors failed to sign and date final reports [21 CFR 58.185(b)]. NextDocs systems prevent the approval of documents such as study reports unless a company’s pre-defined process is followed. In a NextDocs system, a standard workflow would gather the approval of a study director, who could be a third party outside the organization.
The Quality Assurance Unit failed to maintain an accurate master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director [21 CFR 58.35(b)(1)]. NextDocs systems track this information using SharePoint lists, which can be easily transformed into reports.