Audit Scheduling
Goal
In the Annual Audit Plan (AAP), each planned audit has a target year and estimated duration, but it does not have a specific date to start the planned audit. So the objective of this audit scheduling workstream is to build an algorithm to optimize the timing of individual audits given certain factors, including but not limited to: (1) Timing factors: In general, we don’t want to schedule an audit when the site is super busy, so we will try to avoid conducting audits near the time of important study milestones (FPI, FSA, etc.) or near the holiday. (2) Resource factors: factor in the work schedule and workload of the audit manager, auditor, and other individuals involved in the audit; (3) Travel factors: optimize the travel distance and cost for planned audits.
Expected Outcomes
Our expected outcome from this workstream is an audit scheduling tool, that can provide insights for audit managers to decide when to start a planned audit. The specific output format could be either a dashboard or a flat-file (.xlsx, .csv, etc.) generated by a Python script. The operational plan of this tool will be: When the AAP is finalized and/or modified, our audit planning tool will pull all planned audits from the AAP, and for each audit, the tool will propose some recommended audit start dates given the optimization of all relevant factors
Data Integrity
Goal
Across the industry, the integrity of data’s has been a focused area for numerous years. While in certain GxP area such as GMP, the definition of high level of data integrity can be monitored through a common ground of understanding (e.g human error whether intended or not, ALCOA+ principle), in other GxP area such as GCP and PV, defining Data integrity remains rather ambiguous and subject to interpretation of each involved parties.
The purpose of this Work Product is therefore to establish a shared view across the pharmaceutical industry on how to define and evaluate the integrity of data for GCP area and in the Quality processes associated to it.
To do so we will:
- Share the current practices/ or lack of across our different organizations
- Identify the pain point and HA expectations based on observations history
- Align on a minimum requirements for evaluation of data integrity in areas in scope
Expected Outcomes
Set of metrics and trending guidelines that establish the minimum evaluation level that should be performed to monitor the trustworthiness of our data.
Anomaly Detection in Audit Trail
Goal
With the incremental use of electronic data capture tool across the biopharma industry, audit trails which capture the who, what, when and why becomes a critical tool for proactive oversight of data integrity and ensuring the reliability of trial results. The aim of this work product is to identify specific use cases using the industry position paper – Audit trail Review: A key tool to ensure data integrity as a starting point and define analytic methodologies that can be used to proactively oversee the Quality position for data integrity.
Expected Outcomes
- Analytic methodologies established for one or more use cases demonstrating the ability to detect anomalies in audit trails
- Pilot these methodologies across IMPALA members
- White paper describing the methodology including opensource code sharing across biopharma industry
DIA 2023 Workshop
Goal
Leverage DIA’s special forum to educate attendees on the IMPALA consortium and its quality analytics work products. At DIA, IMPALA wants to engage Health Authorities in defining guiding principles for the use of advanced analytics to complement, enhance, and accelerate current QA practices. In addition, IMPALA hopes to initiate partnerships with potential member companies in creating future quality analytics technologies, practices, and products.
Expected Outcomes
- Attendees will be able to articulate IMPALA’s vision and provide examples of IMPALA’s quality analytics products.
- Health Authorities join IMPALA and word to jointly create quality analytics products in service of patients.
- Pharma and Biotech companies join and contribute to the IMPALA consortium.
Quality Briefs
Goal
A change in the Quality paradigm to reduce the burden of retrospective, time-consuming traditional QA activities, and ultimately accelerate approval and patient access to innovative products.
- To ensure quality maintains pace with technological advances, using an outcomes-based approach enabled by Quality Briefs* (QBs), supporting innovation to fast-track new products to patients. To create QBs as a living entity, serving from molecule, filing, through to post-approval and inspections across the pipeline.
- To influence & engage Health Authorities through building trust and confidence via proactive provision of QBs with clear Quality Position conclusions based on risk-assessed Impact Factors*; ultimately speeding up the time to approval.
- To create a future of quality professionals acting as enablers of innovation rather than traditional gatekeepers.
Expected Outcomes
- Establish agreed Quality Brief template available for IMPALA members to pilot
- Pilot use of QBs with selected Health Authorities to engage, influence & ensure fit for purpose: building trust & confidence.
- White paper on QB methodology, including Impact Factors, risk-based Quality Positions and outcomes published for open-source availability to industry and Health Authorities
- Long term: Influence Policy so QBs are required/ expected for submissions and are familiar and understood in inspections
*Terminology may change as the Consortium brings together one-industry approach