Change Controls Toolkit

Downloadable Resources, Instant Access

Provide effective and timely Decision Making, Project Management, and teamwork skills utilizing risk based approaches, especially with real time unPlanned Maintenance Work Order approvals, emergency Change Controls, and Project Support.

More Uses of the Change Controls Toolkit:

  • Pilot: report, review and assess Change Controls related to analytical activities.

  • Guide: electronic Document Management systems or product Lifecycle Management PLM electronic systems, Change Controls, and/or Quality Systems.

  • Drive: review and approve protocols, reports, Change Controls and SOPs related to validation and to the process of implementing/executing validation.

  • Initiate and Manage Change Controls, with associated Documentation Requirements, to completion.

  • Manage work with Equipment Manufacturers, vendors and technicians to review equipment turn over packages and coordinate planned and controlled execution of site acceptance tests and engineering Change Controls.

  • Develop ongoing Change Controls process.

  • Ensure you involve; lead manufacturing related Change Controls for new and existing products.

  • Ensure proper Configuration Management and Change Controls are implemented for your sphere of influence.

  • Evaluate Change Controls and associated Risk Assessments.

  • Be accountable for ensuring documentation and Change Controls are in place for the production deployment activities and transition to Production Support technical teams with the Agile Team.

  • Steer: review and approve Change Controls related to GxP computerized systems.

  • Confirm your enterprise ensures Change Controls, compliance, Risk Management, Business Continuity activities for all Business Systems.

  • Evaluate: own manufacturing related Change Controls for new and existing products.

  • Comply with organization IT Policies, procedures, and Change Controls.

  • Ensure you surpass; lead with expertise in Change Controls systems and documents.

  • Maintain documentation on compliance, inventory, Change Controls, and processes.

  • Secure that your design assess Change Controls for validation impact.

  • Be certain that your enterprise follows proper Configuration Management and Change Controls to promote system stability and to provide an Audit Trail of modifications.

  • Establish that your organization performs work under Project Tasks, evaluates Change Controls and Implementation Plans to perform work.

  • Be certain that your organization understands Design Controls, Change Controls, product, and engineering processes.

  • Direct: review and approve product complaints, Change Controls related to the product.

  • Oversee: monitor and track project Change Controls.

  • Evaluate: documentation of deployment, security, Quality Assurance, Change Controls, and compliance.

  • Evaluate: owner /assessor of Change Controls.

  • Confirm your strategy ensures proper Configuration Management and Change Controls are implemented to promote system stability and to provide an Audit Trail of modifications.

  • Head: track open deviations and Change Controls for proper closure and resolution.

  • Guide: quality event ownership for deviations and Change Controls.

  • Guide: High Availability, Change Controls, patching, Configuration Management, etc.

  • Steer: participation in internal and regulatory audits and ensure follow up actions, and initiates and documents Change Controls as appropriate.

  • Develop: successfully developed issue/risk documents, Impact Analysis, Change Controls, acceptance and Sign Off documents.


Save time, empower your teams and effectively upgrade your processes with access to this practical Change Controls Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any Change Controls 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 Change Controls specific requirements:

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Change Controls 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 999 new and updated case-based questions, organized into seven core areas of Process Design, this Self-Assessment will help you identify areas in which Change Controls improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. What are your key Performance Measures or indicators and in process measures for the control and improvement of your Change Controls processes?

  2. How do you measure improved Change Controls service perception, and satisfaction?

  3. Are you missing Change Controls opportunities?

  4. What is out-of-scope initially?

  5. Can the solution be designed and implemented within an acceptable time period?

  6. How will the Change Controls data be analyzed?

  7. How will your organization measure success?

  8. How do you encourage people to take control and responsibility?

  9. Why a Change Controls focus?

  10. How can you best use all of your knowledge repositories to enhancE Learning and sharing?

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 Change Controls book in PDF containing 994 requirements, which criteria correspond to the criteria in...

Your Change Controls 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 Change Controls Self-Assessment and Scorecard you will develop a clear picture of which Change Controls 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 Change Controls 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 Change Controls projects with the 62 implementation resources:

  • 62 step-by-step Change Controls Project Management Form Templates covering over 1500 Change Controls project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Cost Management Plan: Eac -estimate at completion, what is the total job expected to cost?

  2. Activity Cost Estimates: In which phase of the Acquisition Process cycle does source qualifications reside?

  3. Project Scope Statement: Will all Change Controls project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the Change Controls Project Team have enough people to execute the Change Controls Project Plan?

  5. Source Selection Criteria: What are the guidelines regarding award without considerations?

  6. Scope Management Plan: Are Corrective Actions taken when actual results are substantially different from detailed Change Controls Project Plan (variances)?

  7. Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?

  8. Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?

  9. Procurement Audit: Was a formal review of tenders received undertaken?

  10. Activity Cost Estimates: What procedures are put in place regarding bidding and cost comparisons, if any?

Step-by-step and complete Change Controls Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

2.0 Planning Process Group:

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 Change Controls 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 Change Controls project or Phase Close-Out
  • 5.4 Lessons Learned



With this Three Step process you will have all the tools you need for any Change Controls project with this in-depth Change Controls Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose Change Controls 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 Change Controls 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 Change Controls investments work better.

This Change Controls 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.