Demonstrate that your process works as intended
What is your process for updates to the Validation Master Plan?
What is the process for identifying Validation Master plan quality requirements?
What problems are you Validation Master plan in the process of lean implementation?
Is it a requirement that analytical methods be validated prior to Process Validation?
What performance indicators/parameters should be considered for the validation of a continuous perfusion process?
...Find the answers to these, and more, questions with this Process Validation Toolkit:
- Know your process remains in control.
- Invite users to join your organizations Business Profile.
- As a program manager contribute to the validation process.
- Determine the type of validation for each process.
- Pick the process to build for the validation phase.
- Initiate the validation process and what does that entail.
- Make the validation process consistent and repeatable.
- Affiliate a Rendering provider with your Group.
- Define a batch for a Continuous Process.
HOW THIS TOOLKIT WORKS:
Save time, empower your teams and effectively upgrade your processes with access to this practical Process Validation Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Process Validation related project.
Download the Toolkit and in Three Steps you will be guided from idea to implementation results.
The Toolkit contains the following practical and powerful enablers with new and updated Process Validation specific requirements:
STEP 1: Get your bearings
- The latest quick edition of the Process Validation Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.
Organized in a data driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…
- Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation
Then find your goals...
STEP 2: Set concrete goals, tasks, dates and numbers you can track
Featuring 993 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Process Validation improvements can be made.
Examples; 10 of the 993 standard requirements:
- How to trace the data at the enterprise level between actors for successful payment of the finance after the conditions are correctly met during the transaction processing and validation process?
- Do you lack consistent, reliable, and repeatable process for data warehouse testing including unit, stream, and integration testing during development and validation testing during operation?
- Does the project have adequate processes in place to define the verification, test & validation, and acceptance of systems and system elements at all phases of definition and development?
- Has the board considered the potential role of an independent verification and validation auditor to assist the board in project governance and as a check and balance to external vendors?
- Does the system provide the ability to apply business rules for order processing, as payments, inventory availability, address validation, fraud and so on?
- How must the process change to recognize the critical nature of sales validation to the entire reassessment process as well as integration to other tasks?
- Should process validation data for the premix/pellets/direct compression granules be submitted together with the process validation data of the product?
- What is the expectation on performing process validation without the qualification or validation of utilities that are in contact with the product?
- Does xbrl provide you with opportunities for improved process efficiencies, improved data quality, faster validation, more efficient reporting?
- When you perform a process validation, should the equipment instruments be calibrated immediately after the completion of the validation runs?
Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:
- The workbook is the latest in-depth complete edition of the Process Validation book in PDF containing 993 requirements, which criteria correspond to the criteria in...
Your Process Validation self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:
- The Self-Assessment Excel Dashboard; with the Process Validation Self-Assessment and Scorecard you will develop a clear picture of which Process Validation areas need attention, which requirements you should focus on and who will be responsible for them:
- Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix
- Gives you a professional Dashboard to guide and perform a thorough Process Validation Self-Assessment
- Is secure: Ensures offline data protection of your Self-Assessment results
- Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:
STEP 3: Implement, Track, follow up and revise strategy
The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage Process Validation projects with the 62 implementation resources:
- 62 step-by-step Process Validation Project Management Form Templates covering over 1500 Process Validation project requirements and success criteria:
Examples; 10 of the check box criteria:
- Network Diagram: If the Process Validation project network diagram cannot change and you have extra personnel resources, what is the BEST thing to do?
- Quality Audit: What experience do staff have in the type of work that the audit entails?
- Probability and Impact Matrix: What are the uncertainties associated with the technology selected for the Process Validation project?
- Requirements Management Plan: Who will finally present the work or product(s) for acceptance?
- Activity Duration Estimates: Are measurement techniques employed to determine the potential impact of proposed changes?
- Project Portfolio management: Why would the work force want to know the force rank order of the portfolio?
- Monitoring and Controlling Process Group: Do the partners have sufficient financial capacity to keep up the benefits produced by the programme?
- Issue Log: Are there potential barriers between the team and the stakeholder?
- Stakeholder Register: What are the major Process Validation project milestones requiring communications or providing communications opportunities?
- Scope Management Plan: Is a pmo (Process Validation project management office) in place and provide oversight to the Process Validation project?
Step-by-step and complete Process Validation Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 Process Validation project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 Process Validation project Management Plan
- 2.2 Scope Management Plan
- 2.3 Requirements Management Plan
- 2.4 Requirements Documentation
- 2.5 Requirements Traceability Matrix
- 2.6 Process Validation project Scope Statement
- 2.7 Assumption and Constraint Log
- 2.8 Work Breakdown Structure
- 2.9 WBS Dictionary
- 2.10 Schedule Management Plan
- 2.11 Activity List
- 2.12 Activity Attributes
- 2.13 Milestone List
- 2.14 Network Diagram
- 2.15 Activity Resource Requirements
- 2.16 Resource Breakdown Structure
- 2.17 Activity Duration Estimates
- 2.18 Duration Estimating Worksheet
- 2.19 Process Validation project Schedule
- 2.20 Cost Management Plan
- 2.21 Activity Cost Estimates
- 2.22 Cost Estimating Worksheet
- 2.23 Cost Baseline
- 2.24 Quality Management Plan
- 2.25 Quality Metrics
- 2.26 Process Improvement Plan
- 2.27 Responsibility Assignment Matrix
- 2.28 Roles and Responsibilities
- 2.29 Human Resource Management Plan
- 2.30 Communications Management Plan
- 2.31 Risk Management Plan
- 2.32 Risk Register
- 2.33 Probability and Impact Assessment
- 2.34 Probability and Impact Matrix
- 2.35 Risk Data Sheet
- 2.36 Procurement Management Plan
- 2.37 Source Selection Criteria
- 2.38 Stakeholder Management Plan
- 2.39 Change Management Plan
3.0 Executing Process Group:
- 3.1 Team Member Status Report
- 3.2 Change Request
- 3.3 Change Log
- 3.4 Decision Log
- 3.5 Quality Audit
- 3.6 Team Directory
- 3.7 Team Operating Agreement
- 3.8 Team Performance Assessment
- 3.9 Team Member Performance Assessment
- 3.10 Issue Log
4.0 Monitoring and Controlling Process Group:
- 4.1 Process Validation project Performance Report
- 4.2 Variance Analysis
- 4.3 Earned Value Status
- 4.4 Risk Audit
- 4.5 Contractor Status Report
- 4.6 Formal Acceptance
5.0 Closing Process Group:
- 5.1 Procurement Audit
- 5.2 Contract Close-Out
- 5.3 Process Validation project or Phase Close-Out
- 5.4 Lessons Learned
With this Three Step process you will have all the tools you need for any Process Validation project with this in-depth Process Validation Toolkit.
In using the Toolkit you will be better able to:
- Diagnose Process Validation projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices
- Implement evidence-based best practice strategies aligned with overall goals
- Integrate recent advances in Process Validation and put process design strategies into practice according to best practice guidelines
Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.
Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'
This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Process Validation investments work better.
This Process Validation All-Inclusive Toolkit enables You to be that person.
Includes lifetime updates
Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.
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Checklists:Process Validation Checklist Report on PROCESS.pdf
Checklists:Process Validation Checklist Report on VALIDATION.pdf
STEP 1 Get your bearings:
STEP 1 Get your bearings:Process Validation Self-Assessment Pre-Filled EXAMPLE.xlsx
STEP 1 Get your bearings:Process_Validation_Quick_Exploratory_Self-Assessment_Guide.pdf
STEP 2 Set concrete goals tasks dates and numbers you can track:
STEP 2 Set concrete goals tasks dates and numbers you can track:Process Validation Self-Assessment.xlsx
STEP 2 Set concrete goals tasks dates and numbers you can track:Process_Validation.pdf
..and the Project Management resources in 'STEP 3: Implement, Track, follow up and revise strategy' as described above.
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