Ready to crush it at work? GxP: Ask This;

GxP: Ask This;

TLDR: Ask This;

1. How does data enter the system and how it is ultimately consumed?

2. What does who data integrity and good data and record management expect?

3. Is raw data in the system considered an electronic record and handled/retained accordingly?

4. Which decision does the data influence?

5. Does your supplier have a data integrity policy?

6. How much previous data will you need to review?

7. Do changes to the Data Backups process follow a formal change control process?

8. Does the AMP identify the key systems holding data used in the asset management process?

9. How has your organization ensured its asset management information system is relevant to its needs?

10. Does normal operation or control of the sub system have a direct affect on product quality?

11. What controls does the provider have in place?

12. How do you make sure data is still available in case the provider goes out of business or the solution is no longer offered?

13. How do you test historical data if there was no audit trail?

14. Does the change control procedure involve the data owner for changes to infrastructure?

15. How could you verify whether the data sets compliance to the standards or the defined quality?

16. What is the impact of the data to product quality or safety?

17. Is there a governing procedure for data review including audit trail review?

18. Why have a single monitoring system for multiple sites?

19. What data points need to be audited for each field?

20. How extreme does extreme programming have to be?

21. Are controls in place to ensure that data is complete?

22. What data must be audit trailed?

23. What use is vast amounts of data if unable to put it to good use?

24. How do you know your data is secure?

25. Who is the operator of the cloud where the data resides?

26. Do the test records show that in and out data meets the specifications?

27. Is the information on original data or a certified true copy of the original data?

28. Are you still able to be compliant and meet data integrity requirements?

29. When there is a system error; who will respond and in what time frame?

30. Is there an audit trail in place for user management and system settings?

31. How often do the data change or are new data acquired?

32. Is an investigation initiated when data integrity issues are identified during the review?

33. What data audit logs are available?

34. Who acquired the data or performed an action do you read and understand the data entries?

35. Is the source code tested with associated data and maintained?

36. How does your organization improve the staffing compliance and quality?

37. How do you ensure that sensitive data is protected?

38. Are changes to the system controlled according to its change management process?

39. How do you overcome potential data integrity issues?

40. What is the relevance of data integrity to who stakeholders?

41. Why is data integrity important?

42. What is unit test data analysis?

43. How does your organization instigate appropriate corrective and/or preventive actions to eliminate or prevent the causes of identified poor performance and non conformance?

44. What GxP constraints apply on the data stored in an external cloud?

45. Is the GxP data manually observed and transcribed in another system?

46. Does the system require enforcing for password change at a defined interval?

47. What type of data archiving options are available?

48. How does the red team work together to get the job done?

Organized by Key Themes: QUALITY, PROCESS, SOFTWARE, PROJECT, SYSTEMS, COMPLIANCE, MANAGEMENT, DATA, CONTENT, DEVELOPMENT:

QUALITY:

Are staff automatically blocked from accessing the systems after a defined number of incorrect attempts?

Interface so that your team is responsible for maintaining Quality Assurance Systems/affiliate quality management system to ensure compliance with organization standards and regulatory guidelines.?

Does your supplier have a quality manual?

Lead Information Technology (IT) Quality Compliance activities across your organization including setting strategic direction for the function, partnering with IT Operations to ensure minimal risk and effective mitigation strategies with internal and third party supplier systems, acting as a consultant to the (internal) client community, and managing IT compliance staff to ensure regulatory and business requirements are met.?

Do you need support for integrated file system Snapshots?

Ensure the IT resilience of your manufacturing operations by maintaining your plant floor standards with special attention to compliance programs for your IT support and supply chain (vendors, ISVs, others who access physical systems in your plants) aligned with proper IT change management approaches that integrate with your GxP and Quality process.?

What is advanced threat analytics?

Be certain that your design oversees governance and compliance management processes; implements quality awareness objectives; develops and maintains vendor quality and compliance guidance/reference materials and tools and provides any other support or knowledge necessary to advance the vision of the department.?

Do your purchase order numbers change annually?

Provide proactive input and support to project teams, functional areas and system owners to help ensure quality and regulatory requirements are considered in technology purchase or design and implementation.?

What manufacturing processes are available and what adaptation is required?

Verify that your personnel directs initiatives and projects to establish a corporate-wide Digital Systems Governance Program (development and lifecycle management of policies and standards in support of deployment and maintenance of computerized systems) in collaboration with Quality and other Resilience stakeholders such as Manufacturing, Facilities and Digital Teams.?

What security communities are you actively involved in?

Establish that your company is involved in Quality Management Systems with focus on process improvement.?

Will your organization need access to the equity market in the next several years?

Establish, build, and lead the Commercial QA department, including hiring, management and mentoring of staff, and development and improvement of Quality Systems, programs, procedures, and training to ensure compliance with you and international regulatory requirements and operational efficiencies.?

What are your conclusions regarding regulatory guidelines and capital market expectations?

Make sure your group collaborates with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are being met.?

How often do the data change or are new data acquired?

Ensure your design is involved in electronic quality management systems as deviation management, analytical investigations (OOS), CAPA and change control.?

PROCESS:

What changes if you switched to a cloud service?

Create, manage and implement changes using change control process and ensure quality compliance (GxP and SOX).?

What differentiates the best teams from the others?

Confirm that your design is involved in organizational change process change and how to manage transformations.?

What software requires validation?

Be certain that your company requires regulatory process knowledge as it impacts IT systems and software development (GxP, SOX, Legal).?

Which operating system technologies are supported by your infrastructure?

Make sure your team has involvement transforming businesses through enterprise wide large scale transformation initiatives as digital automation, process redesign, and/or operating model design initiatives.?

Do the test records show that in and out data meets the specifications?

Interface so that your organization address the needs of (internal) customers, business teams, stakeholders throughout the operations deployment and support process, ensuring that what is delivered meets the provided goals and objectives.?

Why to learn to build your own scripts?

Assure your process is processing of information and feedback from Process Sciences and Drug Product Engineering groups to refine problem statements, scope work, identify areas for improvement and build implementation plans.?

Which operating system technologies are supported by your infrastructure?

Confirm that your process partners with platforms to conceptualize solution architectures adhering to documented Directions and Standards while addressing business strategies, business capability requirements, business processes, information assets, and the operating model of the (internal) client business area.?

How do you receive support for your implementation efforts or on behalf of your customer?

Check that your design has involvement participating in a comprehensive support process for a variety or internal and external resources.?

Are new configurations anticipated to be easy to implement and understand, or will you need a dedicated team to manage the changes?

Work to improve processes and partner with the analytics and applications team to automate and implement such process changes.?

Does the network support wireless devices?

Be sure your strategy provides entry level support for key Validation processes.?

SOFTWARE:

What happens after the contracts are signed?

Certify your staff acts as liaison between Quality Assurance and project team to assure that GxP software is implemented in compliance with applicable regulations and guidelines.?

How do you manage the change of your target?

Manage and execute implementation of regulated GxP software for (internal) clients including activities such as system selection, vendor auditing, business requirement mapping, validation planning/oversight, system documentation, software testing, data migration, change control, and training.?

Is the quality organization involved?

Make headway so that your operation is involved in GxP and software validation regulations.?

What should one consider when it comes to the audit preparation, conduct and follow up?

Understand and adhere to corporate standards regarding applicable Corporate and Divisional Policies, including code of conduct, safety, GxP compliance, data security, and the software development lifecycle.?

What is involved in Data Integrity?

Be certain that your strategy is involved in managing software implementations applications is highly valued.?

Is the interpolation distance defined in the geomorphic editing window entered correctly?

Make headway so that your design is involved in video editing and audio editing software.?

How should trace call results be interpreted?

Make sure your workforce works closely experienced in communicating and negotiating technical software and hardware architecture, design features, and operations.?

Are there crucial milestones that the vendors should be aware of?

Confirm that your staff participates on all hardware and software evaluations and maintains vendor contracts.?

How do you leverage GAMP good practice principles?

Guarantee your workforce is understanding and application of standard software engineering principles.?

Has the backup and recovery procedures been qualified/validated?

Make sure your workforce ensures that all GxP software is inventoried, assessed, validated, and maintained according to applicable procedures.?

PROJECT:

What should the role of internal audit be in your organizations move to the Cloud?

Liaison so that your team is leading the IT change management process for functional area including overseeing and complying with the Solution Development Life Cycle SDLC to ensure projects meet appropriate GxP, SOX, etc.?

How might configuration change in any given release?

Make sure the Product Owner works with business owners, Business Project Managers and potentially (internal) customers to define product release requirements, with Business Development and Marketing to understand and support the go-to-market strategies and with IS and other departments to ensure that the product is effectively supported after release.?

How much quality is enough compliance?

Safeguard that your workforce serves on core team for execution and implementation of various projects including process improvement, capital expansion, software implementation from a Site Engineering standpoint.?

Does the system meet the criteria?

Provide support to internal personnel and external partners to resolve issues, identify gaps, and recommend changes to meet project goals, deliverables, and compliance requirements.?

How does the adversary obtain domain dominance status?

Ensure your process ensures technology projects are built and documented in accordance with your strict internal and external regulations, including information security, privacy and GxP and all relevant compliance requirements.?

How many ip addresses exist per network?

Manage internal IT staff and external IT resource to ensure daily operations for critical business applications and infrastructure, proper staffing levels for project work and efficient execution.?

How much do you trust your partners?

Ensure your organization should have involvement with business analyst methodologies to establish a project which include scoping, partner analysis, activity modeling, story boarding, and requirements tools.?

What security communities are you actively involved in?

Be confident that your company is involved in working in a project team environment.?

What big unknowns should be considered during the planning process?

Establish that your design assures quality topics and requirements from GxP are considered in integration projects.?

What sops will be impacted with the implementation of serialization?

Provide audit and inspection support for portfolio, including, where feasible, advising the project teams during preparation and conduct of audits and inspections as per applicable SOPs.?

SYSTEMS:

Do the specifications for the upper acceptable limit for particles of defined size meet cGMP?

Lead system integration projects, develop and design IIOT applications, and configure and deploy electronic systems to drive digital transformation initiatives and ensure released applications meet regulatory compliance requirements.?

Why is your solution the perfect fit?

Develop requirements for business requirements, system security, user roles, workflows, data flows, GxP regulations and how such systems fit into the larger IT infrastructure.?

Does asset meet Service requirements?

Make headway so that your organization plans, leads and executes audits to verify execution of the technology strategy to help ensure that R and D systems, software and instruments meet R and D standards and regulatory requirements.?

What are the key learnings and outcomes of cases where applications have been used?

Be confident that your design is interfacing with area Business Systems Owner, responsible for training end users, handle the daily business requirement and guiding users to use the system correctly.?

Does the facility utilize computerized systems for managing GxP activities or data?

Generate, review and approve validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation.?

How are current or new backup procedures validated?

Be confident that your workforce is involved in System Development Lifecycle methodologies and validated systems.?

Are you performing the testing primarily to meet a specific compliance requirement?

Safeguard that your design ensures training policies, procedures, systems and records meet external requirements as well as business needs.?

How do you package and sell your support?

Safeguard that your process utilizes department policies, methodologies, standards and guidelines with regard to systems support and/or software deployment.?

Has terminology actually been defined?

Coordinate and work with network engineers, systems engineers, solution architects, IT Security and/or an Implementation Managers (IM) to ensure to ensure timely delivery of defined project deliverables.?

COMPLIANCE:

Are you still able to be compliant and meet data integrity requirements?

Support with the development and implementation of changes to re engineer site change control business processes to meet department, compliance and (internal) customer needs.?

Are compliance/noncompliance reports configured in a way that meets your organizations requirements?

Ensure your company is accountable for working with Business Process Owner (BPO), IT Security, IT Infrastructure, and compliance teams to ensure the Windows product meets all policy and regulatory requirements.?

How is compliance around activities being managed in your organization?

Consult with the compliance business areas on development and managed deployment of system enhancements to ensure efficient usage and maintenance of technology.?

Has approval been formally recorded?

Decide on Quality related issues in the harmonization projects and ensure compliance to GxP requirements.?

How do you support users in different languages?

Establish that your operation is overseeing contingency planning and IT security and compliance by establishing controls and processes in support of data security, PHI, SOX, GDPR, HIPAA and other relevant regulatory requirements.?

How do you measure the quality of the work?

Work with project teams to ensure compliance with regulatory requirements as FDA, CAPA, and GxP, as well as internal policies and processes.?

Does the application have an audit trail for changes to security roles?

Establish that your operation provides guidance and counsel on technology, enhancements and upgrades available that drives delivery of compliance solutions consistent with business direction.?

Does the vendor have sufficient testing practices for the risk level?

Create/review high level compliance deliverables Create Validation Plan, Data Migration Plan, GxP risk Assessment, reviewing the specifications and Testing documents for GDP (Good documentation Practices).?

Are there particular clinical areas that need support?

Certify your personnel applies IT project delivery, application support and compliance knowledge and involvement to CAPA investigations.?

How will risk management and improvement activities relate to the strategic goals?

Develop and manage GxP and Compliance training in alignment with the Quality and Regulatory departments.?

MANAGEMENT:

How do you package and sell your support?

Partner with IT Operations to assess risk and develop mitigation strategies and develop validation processes to support system management according to applicable regulations.?

Do changes to the Data Backups process follow a formal change control process?

Warrant that your staff is responsible for inspection management processes for information systems and engages in Preparation, Support and Follow up activities for Inspection Readiness across GxP areas.?

Does the facility utilize computerized systems for managing GxP activities or data?

Support initiatives and projects to establish a corporate-wide Digital Systems Governance Program (development and lifecycle management of policies and standards in support of deployment and maintenance of computerized systems).?

What areas show obvious lack of resources?

Be certain that your organization is responsible for organizing and management of Annual Product Reviews, including, aligning a cross functional team on product and/or process CAPAs, identifying product trends, and drawing product related conclusions.?

What exactly are AWS responsible for?

Secure that your process is responsible for the project management of ERP system and other solutions that are integrated with the ERP system.?

Does technology increase or decrease the risk?

Safeguard that your operation (internal) clients draw upon your deep industry expertise, program and change management capabilities and analytical objectivity to help improve business productivity, drive technology-enabled business transformation and increase shareholder value.?

Are resources utilized and released as expected?

Interface so that your process oversees organizational facilities management that a system of archiving facilities documents and project study files is in place and is secure as expected by pertinent regulatory requirements.?

Is there any vertical flavor to what you are seeing in terms of the demands for pricing cuts?

Work collaboratively with product managers, designers, researchers, program management and front-end developers across the business to champion the information creation process and incrementally realize the long-term vision.?

Does the vendor monitor the performance of its suppliers, contractors, and service providers?

Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.?

DATA:

How do you deliver quality products while ensuring compliance with GxP?

Be a key team member on process development teams by ensuring that decisions of the team are risk based and data based to a known level of confidence.?

Is full packet capture capability important to you?

Own the connectivity of research and process development data to GxP systems to ensure consistent definition and capture of data into the data lake and advanced analytics platforms.?

How does avm support integrations with specific cmos, 3pls or other trade partners?

Safeguard that your process collects data on supplier and partner performance to ensure compliance to requirements.?

Are you still able to be compliant and meet data integrity requirements?

Confirm that your workforce is ensuring the scientific quality of data in order to meet GxP regulatory expectations.?

What specifically could be improved?

Recommend and implement ways to improve data reliability, efficiency, and quality by working closely with your data warehouse development team.?

What coding languages are utilized to develop the web applications that will be tested?

Be certain that your process design and develop data, software, or technology solutions to answer scientific or business questions.?

Are your personnel employed directly by your firm?

Make sure the Data Integrity specialization is responsible for supporting all areas of your organization for overall GxP/CGMP compliance as it relates to data integrity.?

Have your network management practices changed over the last quarter?

Make headway so that your strategy is involved in applicable data privacy practices and laws.?

What support is provided in cases of breach?

Develop, lead, or review the creation of ETL strategy to support the strategic requirements for data migration process.?

Will the deliverables be produced upon completion of a test process?

Define, lead, and project manage by bringing together/interpreting internal and external data to produce insightful findings matched to business requirements.?

CONTENT:

What is involved in Data Integrity?

Be sure your process is involved in quality control and managing output for content.?

How are designated responsibilities for delivery of asset plan actions documented?

Improve the quality of content, adhere to the established standards and guidelines, and deliver on time.?

How is the categorization classified in your organization?

Be confident that your organization assesses content requirements, identifies cross team impacts, and coordinates resources to ensure successful execution.?

Are the vendors support hours sufficient to support your business?

Confirm that your design is editing content written by product managers, support advocates, and engineers.?

Are compliance/noncompliance reports configured in a way that meets your organizations requirements?

Participate in the Developer Education peer review process by providing and accepting feedback to ensure content meets your high standards.?

How frequently are backups performed?

Certify your process provides productive feedback of content to guide performance across all functional activities performed on the Program.?

Does the amp include a summary that provides a brief overview of the amp contents?

Ensure your group learns the product, and reviews and provides feedback on content prepared by team members for clarity, consistency, quality, and depth.?

Are dates in a format that makes the day, month, and year and time zone clearly discernible?

Assure your organization (internal) customers informational background, needs, and objectives are always at the forefront of your mind, and you guide your team to create content that makes adoption of your products easy.?

Are there controls for how a virtual server images are created/destroyed?

Operationalize the Products division by offering feedback on product prototypes, developed code, and general user perspective captured through writing assistance content and learning about the software you create.?

Do you archive the empower data?

Be a part of this function, the R and D Operations Technical Writing team writes and publishes technical documents and associated content for products and solutions.?

DEVELOPMENT:

Are compliance/noncompliance reports configured in a way that meets your organizations requirements?

Verify that your operation applies full development life cycle methodology, including requirements gathering, process maps, and ensures the design stays true to the requirements so the delivered solution meets requirements.?

What is different about penetration testing the cloud?

Evangelize and facilitate the development and implementation of quality controls and departmental standards to ensure standardized KPIs and consistent measurement methodologies.?

Do you need support for integrated file system Snapshots?

Make sure your company is leading the development of the enterprise IT strategy and roadmap and ensuring that internal and external teams integrate with the overall IT and line of business enterprise strategic plans.?

How do you monitor and support the solution if it fails?

Participate in validation activities, specifically around development of test scripts and other GxP documentation generated during system support and validation.?

Does the facility utilize computerized systems for managing GxP activities or data?

Check that your design liaises with IT and other cross-functional business teams in the development of GxP deliverables, SOPs, Work Instructions, Policies and other critical documentation for GxP regulated computerized systems.?

Is the quality organization involved?

Be certain that your process is involved in agile software development methodology.?

How will the governing body be involved?

Guarantee your group is involved in the Software Development Life Cycle (SDLC) and Agile software development in a SaaS and software platform environment.?

Is the GxP data manually observed and transcribed in another system?

Serve as the conduit between the business community and the software development team through requirements, design, testing and implementation.?

Why AWS for GxP regulated workloads?

Be sure your strategy supports Software Development teams as SQA lead for the automated testing and implementation of regulated IT applications.?

Who has access to system upgrades and system site support?

Execute improve Digital Systems Development Lifecycle (SDLC) approach in support of GxP systems across the Resilience network.