Issue link: https://www.e-digitaleditions.com/i/1483907
www.biopharminternational.com Manufacturing and Facilities 2022 eBook BioPharm International ® 27 Audits And inspections IT/quality assurance (QA) support to risk assess whether the system may be used for GxP work or if alternate con- trols need to be put in place such as a procedural control. It is preferred that a technical control be employed to prevent data deletion. If deletion cannot be prevented, the ATR process should be designed to detect that spe- cific activity. It should be noted that, in many cases, ATR is most logically performed concurrent with other data review activities. The severity of any residual risk should be assessed. The frequency for ATR should be commen- GxP Data Document that critical parameters are locked, data cannot be changed, reviewing the displayed/ printed parameters is all that is necessary, no additional audit trail review is needed. CAT#2 Yes Are electronic records generated? No No Audit Trail available to review; there is no electronic data. CAT#1 No Are changes tracked in a reviewable audit trail? No Document the parameters that require review and the process to look for these changes each time, and state that no additional audit trail review is necessary. CAT#5 Yes STOP and discuss with additional business/IT/QA support to risk assess whether system may be used for GxP work or if alternate controls need to be put in place. No Can these parameters be checked by a 2 nd person prior to acquisition/processing and locked? Are changes inherently reviewed in the process? Document that parameters are checked on entry, critical parameters are locked, data cannot be changed, no audit trail review is needed. CAT#6 Identify specific changes that can be made. Review audit trail for these specific changes Develop a list of items to be checked? CAT#4 No Yes Can changes in the parameters affect the results /data? Document those changes that can be made and although changes can be made, these changes don't have an impact on the results/data. CAT#3 No Yes Can parameters / data / metadata be modified? Yes High Impact data? See Fig 2 Yes Yes Note: Ensure processes / practices for managing paper records are ALCOA+ compliant. Note: Includes parameters and metadata both during and after a run such as: • Time • Date • Who • Acquisition parameters • Processing parameters • Methods Note: If the business process already includes a review of the parameters and metadata there may not be a need for an additional electronic audit trail review. Categories 1, 2 and 3 are preferred, the acceptability of categories 4, 5 and 6 are dependent on the risk tolerance of a company as well as the availability of alternative compliant instruments FIGURE 1. Risk assessment tool for determining audit trail review requirements. Where ALCOA+ is attributable, legible, contemporaneous, original, and accurate, plus the data needs to be complete, consistent, enduring, and available. Categories 1, 2 and 3 are preferred, xthe acceptability of categories 4, 5 and 6 are dependent on the risk tolerance of a company as well as the availability of alternative compliant instruments (1). FIGURES ARE COURTESY OF THE AUTHORS