QAx covers:

Below are our learning objectives for our Onboarding experience. We hope that as you move through your Trello board the objectives are achieved and this enables you to thrive & add value towards achieving your individual and our company ambitions.

Objective1: Increase your knowledge of QAx and how the sub-functions works so you understand how you add value

Objective 2: Increase and build your core knowledge and skills so you can focus of delivering outcomes.

Objective 3: Increase your networking to improve your opportunities to forge relationships

If at any point you want to discuss these objectives please reach out to your Manager, Team or other assigned resources (e.g. Mentor, coach, trainer etc). Ongoing check-in's across your onboarding experience will help you to see how you're progressing.

- Quality Manual: This training should have been assigned to you in Cornerstone. This procedure outlines the importance of the Quality Management System (QMS) for GCP, GVP and Medical Device processes. PDQ oversees this process and ensures the system is applied throughout the organization.

- Outcomes: Outcomes are focusing our attention on impact and value outcomes-based planning. As QAx, our culture and language defines the system - to accelerate, the system needs to enable our strategy (based on the PD 2023 vision and defined in the PDQ Narrative) by aligning our QAx Strategy, Language, outcomes and how we operationalise and accelerate.

- Impact Factors: Focus areas (15) based on activities presenting greatest risk or opportunity. Each Impact Factor has a target Quality Position (QP) and may have sub-positions. Additional information is available in the following Guidance Document: BI-0300049.

Add an item

Review the information and links on the cards in this list to learn more about Key Trainings and Access for QAx.

Applying risk assessment is key to how we work.

Review the information and links on the cards in this list to learn more about Risk Assessment for QAx.

- OneQMS Hub Will replace QUEST in 2023

- Link to gSite where the Useful Systems, Tools and Links is housed

- QAT (QPL Assignment Tool), is an app in Quickbase that manages the Molecule/Post Approval Portfolio Decisions. QAT automatically pulls critical information from various source systems, flag changes from one LSP report cycle to the next, and has a real-time connection with QART. For more details on QAT, please click here.

Accessing this page requires Roche network or VPN/Pulse Secure connection.

SOPs that are mandatory include the Audit and CSFM SOPs.

- Global: Clinical and Safety Finding Management (SOP-0105265) [Note: Included in QUEST Training]

- Global: Quality Assurance Audits (SOP-0105363) [Note: Included in QUEST Training]

- SOP-0107273, Global: Serious GCP Non-Compliance or Misconduct

- SOP-0120965: Global: Quality Assessment for Incoming Partnered Assets

- Phoenix Portal An in house developed system to enable migration from condor in waves (i.e., to mitigate the impact of migrating everything from condor at the same time) and to enable some features for the end user which are not native yet in QualityDocs (such as process navigation and glossary hover-over functionality).

- Quality Docs

Links to Review

- Additional information is available in the following Business Instruction Document: BI-0300049

- Quality Positions & Impact Factors

- Development Molecule QPL List

- BI-0300049

QUEST System
The QUEST system is the new system for managing Findings against Roche GCP and GVP processes that result from all three types of Quality Events (audits, inspections, and self-identified deviations). The QUEST system sits on the cloud-based Veeva Vault platform and replaces the legacy QPP and pDeviation systems.
Confirm with your manger if access to QUEST is needed and what type of access. Once confirm you manager must submit a ticket to initiate the training process for you. Please see the QUEST Hub Onboarding page

Please note: if you have access to both QUEST and QualityDocs, the system will automatically take you where you were logged in last time. You can switch between the two instances by clicking the arrow next to "Quality Production" section in the top right corner.
Quality Pharma = QualityDocs
Quality Production = QUEST

- Audit and Inspection Lead - System Access Training

- Reviewer Pool - System and Process Training

- CAPA Effectiveness Verification Audit Manual

The Quality Program Lead (QPL) is responsible for developing the molecule-specific Quality Strategy, an associated program of audits and production of the molecule QBD.

- QPL toolkit The QPL provides all the processes and tools for the QPL activities. The links below are all accessible via the toolkit, but call out again for ease of reference

- QPL Molecule Manual. QPL Product Manual.The QPL Manuals (Product and Molecule) describe the ‘When’ and ‘How’ PDQ-Quality Assurance Programs (PDQ-QAP) QPL deliver the Development Molecule or Post Approval Product work.

- Review and understand the Impact Factors and Impact Factor Tools Impact Factors are focus area presenting the greatest risk or opportunity defined for (1) patient protection and (2) reliability of clinical results and PV system. Each Impact Factor has a target Quality Position and may also have Quality Sub-positions.

- Quality Strategy & Reporting Out Templates. The Quality Strategy is the plan that lays out the audits needed to write a conclusion against each Impact Factor and it’s quality position. QSRC enables visibility of the strategy and the likely/evolving narrative.

- Useful Systems & Links: A list of useful product and molecule related systems and links (detailing training, access and Impact Factor alignment).

- Risk Tracker under Molecule and Product toolkit

GVP inspections examine the pharmacovigilance system and processes in place at Roche and service providers contracted by marketing authorization holders (Roche) to carry out pharmacovigilance activities on their behalf. GVP inspections examine whether the processes followed comply with the applicable national laws, international pharmacovigilance directives and requirements of the Health Authority.

- PDQ Inspection Management Framework

- Inspection Management gSite

- QPL Inspection Resoucres

- Introduction to Medical Devices and Associated Regulations

- Module 1: Document Controls Overview for Medical Devices

- Module II: Document Controls Overview for Medical Devices

- Module 1: Design Controls Overview for Medical Devices

- Module II: Design Controls Overview for Medical Devices

- Read the PD and PDQ Business Continuity Plan (BCP) Overview Site. See the actual PDQ BCP

How are they used:
A risk-based approached based on a defined set of Impact Factors is used across internal processes, service providers, affiliates, license partners, and computerized systems, as well as product-specific and molecule specific strategies. There are 15 impact factors in total.

Each of the impact factors has a Quality Position, which is representative of an ideal state of quality. The quality position can be delineated by a series of sub-impact factors/positions, which further describe and contribute to the ideal state of quality for the impact factor.

Assessment of the impact factors includes a review of the quality assurance evidence, generated through audit activities, against the Quality Position/sub-positions.

Link to Review:

- Additional information is available in the following Guidance Documents: BI-0300049

- Impact Factors, Quality Positions, Sub-Impact Factors and Sub-Quality Positions listing can be found here. Also see the QPL card for QPL specific Impact Factor tools

- Report 126 shows Positive Evidence and Findings by Impact Factor

- Video recording

- Molecule Risk and Issue Tracker Tool and Impact Factor Execution Strategy Template

- AL and PL risk documentation and tool - being developed please reach out to your manager or buddy in the meantime

Your Manager: Your manager helps foster connections with others and provides ongoing updates on the broader strategy to aide in your own development.

Communities of Practice and Forums: See cards below

PDQ Connect: Important announcements about PDQ are posted here

Trello questions: If you have any technical questions as you use this Trello board, please reach out to Maureen Prather (mcmurphy@gene.com)

Audit is no longer a tool deployed purely to reactively detect issues for fixing.

Review the information and links on the cards in this list to learn more about Audits for QAx.

- Review audit toolkit

- Review existing audit reports and audit plans. Note: once RADA groups are updated you will receive all audit report. Self-subscription to audit type distributions lists is also available please click on this link for additional information. Accessing this site requires Roche network or VPN/Pulse Secure connection.

- Attend the report writing training (this is being planned - look out for invites and see the refresher video as a supplement/JIT))

- Review Report Writing Refresher Training Video

- eArchive: Electronic archive to access archived records (e.g. deviations, audit and inspeciton reports generated prior to QUEST)

The audit Proposal Owner should define the audit’s objective questions to be holistically measurable to support the Quality Narrative/Position & Strategy that meaningfully informs/contributes to the positive affirmation and current risk status of a program/product.

- Developing Objective Questions for Audits Guidance

- QPL Objective Questions Tool

- Report 126 show Positive Evidence and Findings by Impact Factor

- Watch the Audit Certificate Process Awareness Session 12 Aug 2021

- Complete the DocuSign Training: To gain access to do eSignature, the following training must be completed via Cornerstone: - DocuSign User Training - DocuSign for GxP User Training

Please see the 'Your Learning Plan' card for all aspects of DAVE (not just Data)


- https://trello.com/c/lLRAGJj8

- Practical PV Auditing.

- Good Clinical Practice Auditing - Principles and Practice

- Auditing Computerised Systems

The ACP training is optional! Please note: after completion of the in-class part of the program, you are required to lead 3 audits within the next 12 months in order to receive your certification.

- Auditor Certification Program gSite

Analytics: - Analytics (in the context of Audit) is a tool (not an activity) to visualise data during audits to enable better / quicker decision-making and conclusions to be made when answering objective questions. (Analytics may also be used to support other PDQ work eg Risk Assessment / QMS etc or be conducted as part of 1st line of control used by embedded Quality groups)

Review the information and links on the cards in this list to learn more about Data Mastery for QAx.

- PDQ Data Analytics. Information and resources relating to Data Analytics, Data Packages and training information.

- Current set of dashboards available

- QUEST Analytics Self-Service Training

- QUEST Analytics Self Service Resources

- QUEST Analytics Self-Service Graduate Certificate

- QUEST Analytics Dashboards and Reprots

Links to Review

- Certificate In Data Basics: This elearn module is recommend for all, but not a pre-requistie for the Data Analytic University (DAU) - Graduate Excel only course Objective The aim of this course is to provide a foundational level understanding in analytical capabilities so that the learner is capable of using and applying analytics tools to solve real-life GxP problems. Course Overview This interactive e-learning course is divided into 9 bite size chapters covering: Demystifying Analytics; Naked Statistics for Data Analysis; How Data Might Fool You. Sign-up via Cornerstone

- DAU Study Analytic Graduate Certification. The aim of this course is to build upon the existing capabilities acquired in the Certificate in Data Basics course and for learners to become confident in performing data analysis independently - whether that’s to answer a question using data, visualize the data or tell a story to key stakeholders using data.

- Data Analytic University (DAU) - Graduate Excel only. The (DAU) - Graduate Excel only course is an extract of the DAU Study Analytic Graduate Certification that focuses only on the Graduate excel module. The aim of this course is to build upon the existing capabilities acquired in the Certificate in Data Basics course and for learners to become confident in performing data analysis independently using advanced excel skills. This course is a 2 days ILT course (4 hours each day). Email notifications of the next offerings are send out for sign-up

Statistics boost training sessions aim to upskill the organization (PD and all departments across Roche) on relevant statistics topics and how to apply them effectively in drug development.

Narrative: - A summary of the Quality of a Molecule, Product, Affiliate or Process using the Impact Factor framework substantiated by the evidence coming out of audits conducted to answer objective questions and providing a definitive conclusion on the Quality position of the entity described in the narrative. The purpose of a narrative is to provide assurance to HAs on the quality of Roche molecules / products / processes and affiliates to accelerate approvals for patients.

Please note Narratives have been rename to QBD (see QDB (narrative) card below)

Review the information and links on the cards in this list to learn more about QBDs for QAx.

- Attend the QB Capability Training series

- Review existing QBs to gain exposure

- There is work ongoing to further enhance the QB template and tools to increase reuse and the accessibility of the conclusions. Additionally the Chapter Lead for Quality Policy will be working on a strategy for engaging industry and regulators around the approval and maintenance of health care solutions, including how QBs supports the strategy.

- Integrated Healthcare gSite for Guidances and Podcasts

- Essentials to Clinical Quality for Next-Generation Sequencing- part 1

- Essentials to Clinical Quality for Next-Generation Sequencing- part 2

- Integrated Healthcare Solutions gSite

- PHC Quality Uncovered - Podcast Series

As always, feel free to add, edit and remove as you see fit. This is your board to use as you chose.

Actions:

- Check your monthly master board for any card updates: Copying cards on trello Archiving cards

- Check for any new Cornerstone training to complete

- QAx Training Plan

The training oversight includes the QAx mandatory training as well as the recommended training for all colleagues in QAx.

Links to review:

- QAx Capability & Training oversight

DAVE - The Fearless Quality Professional Competency Model

The PDQ Talent Team is excited to be able to shape our evolution in PDQ from Gatekeepers of Quality to Accelerators of Healthcare Solutions. We call this evolution "The Fearless Quality Professional", complimented by DAVE, our PDQ competency model. This year, we will work on enhancing our PDQ Talent Strategy by building the DAVE sub-competency model process, including self assessments, opportunities for connectivity, and embedding the DAVE model into our culture and talent processes.

Links to Review

- To subscribe to DAVE's channel, click here

- Review the DAVE gSite

- Subscribe to "Let's Fika"

- DAVE Capability Assessment

Communities of Practice are intended as a place where you can go to share, learn and expand your knowledge and ideally consist of experts and people who are still developing expertise. They are not intended to replace the existing means by which we make decisions on day-to-day work.

Links to Review

- Data Analytics CoP

- CS CoP Community of Practice

- GCP CoP Community of Practice

- CS CoP Community of Practice

- CSFM PDQ SMEs

- CoP CS Slack channel: # cop-cs

- CoP GCP Slack channel: # cop-gcp

- CoP GVP Slack channel: # cop-gvp

QPL forums for Product and Molecule QPLs

Links to Review

- QPL Community QPL virtual community is a space to share ideas, blogs, interesting topics, news, and QPL agenda topics in order to increase our explicit and tacit knowledge sharing, and develop new ways of working.

- DARWIN - https://trello.com/c/q5QmTUX4