Process Validation Toolkit

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Lead process characterization, lead process scale up, lead process technology transfer, lead process troubleshooting, lead process optimization, continuous lead process improvement, and lead process or equipment validation.

More Uses of the Process Validation Toolkit:

  • Assure your organization interfaces with program management, project management, engineers, manufacturing line personnel, quality assurance, and others in the development of manufacturing processes.

  • Be certain that your organization generates, review and approves engineering, manufacturing and quality procedures necessary to support equipment validation/revalidation, launch, and normal production schedules.

  • Confirm your organization develops and/or implements systems improvement projects and supports maintenance and production groups in resolving technical and engineering issues.

  • Make sure that your organization assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

  • Direct: plan, organize, and direct the technical activities of the process design team to ensure technical success and adherence to the project scope, schedule, budget and quality requirements.

  • Standardize: intermediate knowledge and working application of validation principles and guidelines and industry practice, fmea, and risk management.

  • Develop overall api strategy, timelines, budgets, risks and mitigations plans of all process development, starting materials, and manufacturing campaigns.

  • Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations.

  • Apply sound engineering theory and critical thinking to effectively resolve a variety of technical problems of moderate to large complexity and scope.

  • Ensure you classify; recommend, and help justify equipment/tools used for processing material, and manage implementation to meet cost, quality and schedule goals.

  • Establish that your organization generates, execute, review, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations SOPs, specifications and other applicable acceptance criteria.

  • Provide key engineering oversight to manufacturing change management activities through execution and reporting of accurate, thorough and insightful test plans, protocols and reports consistent with organization SOPs.

  • Ensure that stability data supports the retest /expiry date and storage conditions of the product and that a system is in place to assure trending of data for any anomalies.

  • Evaluate, select and apply standard design techniques, procedures and criteria to make minor design adaptations and modifications.

  • Provide manufacturing insight and project deliverables to new or modified product projects and ensure timely transition into manufacturing, with consideration to robust design, cost effectiveness and process validation.

  • Enforce your organizations Quality Standards and Procedures for Computerized Systems, as defined in your organizations governing Quality Management System.

  • Coordinate the efficient and effective specification, procurement and installation of new equipment and upgrades with suppliers and sub contractors.

  • Warrant that your organization supports new product launch activities through process validation, part cost justification, packaging, process FMEA and control plans.

  • Confirm your organization provides support to the Manufacturing organization to optimize existing processes, and to ensure that processes are properly validated and documented using good manufacturing processes.

  • Develop and articulate robust strategies for validation of processes and systems through development and release of holistic validation plans.

  • Identify and execute projects to reduce product cost, improve product quality, improve yield, product quality and supply reliability.

  • Improve existing process capability levels through thoughtful analysis and investments in new equipment and upgrades to existing processes.

  • Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and reports.

  • Devise: implement process improvements using effective benefit and risk analysis supported by applying data analysis and effective planning.

  • Arrange that your organization analyzes product development feasibility, taking into consideration production cost optimization requirements, existing and/or additional technology and resources needed.


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

Start with...

  • 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:

  1. 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?

  2. 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?

  3. 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?

  4. 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?

  5. Does the system provide the ability to apply business rules for order processing, as payments, inventory availability, address validation, fraud and so on?

  6. 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?

  7. Should process validation data for the premix/pellets/direct compression granules be submitted together with the process validation data of the product?

  8. What is the expectation on performing process validation without the qualification or validation of utilities that are in contact with the product?

  9. Does xbrl provide you with opportunities for improved process efficiencies, improved data quality, faster validation, more efficient reporting?

  10. 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:

  1. Network Diagram: If the Process Validation project network diagram cannot change and you have extra personnel resources, what is the BEST thing to do?

  2. Quality Audit: What experience do staff have in the type of work that the audit entails?

  3. Probability and Impact Matrix: What are the uncertainties associated with the technology selected for the Process Validation project?

  4. Requirements Management Plan: Who will finally present the work or product(s) for acceptance?

  5. Activity Duration Estimates: Are measurement techniques employed to determine the potential impact of proposed changes?

  6. Project Portfolio management: Why would the work force want to know the force rank order of the portfolio?

  7. Monitoring and Controlling Process Group: Do the partners have sufficient financial capacity to keep up the benefits produced by the programme?

  8. Issue Log: Are there potential barriers between the team and the stakeholder?

  9. Stakeholder Register: What are the major Process Validation project milestones requiring communications or providing communications opportunities?

  10. 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.