Title 21 CFR Part 11 Toolkit

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Store and manage data within your organization

 

Are there utilities/tools available to ensure that an electronic records audit trail captured using one version of software will be readable in the next version of the software?

Does the computerized system requires electronic signatures on the electronic records?

What is your record retention policy regarding electronic business records?

Is an electronic records audit trail retrievable throughout the records retention period?

Are all electronic records included in system backups?




...Find the answers to these, and more, questions with this Title 21 CFR Part 11 Toolkit:

  • Know what information is an electronic record.
  • Prove the parties agreed to use electronic means.
  • Compute fringe benefit costs as an hourly rate that can count towards fulfilling your prevailing wage obligation.
  • Share your work with someone at a different site.
  • Remove unwanted spaces in your samples.
  • Use quality values to review data.
  • Select electronic records for preservation.
  • Get a qualified electronic signature.
  • Create and manage time limited review periods.



HOW THIS TOOLKIT WORKS:

Save time, empower your teams and effectively upgrade your processes with access to this practical Title 21 CFR Part 11 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Title 21 CFR Part 11 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 Title 21 CFR Part 11 specific requirements:


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Title 21 CFR Part 11 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 990 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Title 21 CFR Part 11 improvements can be made.

Examples; 10 of the 990 standard requirements:

  1. Will your organization accept the electronic approval through the workflow system as the signature where the user who provides the final approval is validated and an audit trail it captured?

  2. Are controls in place to maintain the uniqueness of each combined identification code and password, that no individual can have the same combination of identification code and password?

  3. Is there a written policy that hold individuals accountable and responsible for actions initiated under electronic signatures, in order to determine record and signature falsification?

  4. Are there regulations for which your organization should now require more specific forms of electronic signature in order to safeguard the integrity and authenticity of the signature?

  5. Are there utilities/tools available to ensure that an electronic records audit trail captured using one version of software will be readable in the next version of the software?

  6. Has the given organization been given a clear, irrevocable and undisputable mandate by the highest decision making circles for strategy compilation and program development?

  7. Is the complete review of the batch record for a critical process step, meaning a synthetic step, or is it a review of the critical variables within the critical step?

  8. How do you assure that the material that will ultimately be used in product for human use is safe considering many exemptions as considered about validation?

  9. Do records include storage of instrument control, sequence, data acquisition and data evaluation parameters together with audit trail and raw data?

  10. Are electronic audit trails kept for a period at least as long as the subject electronic records and available for organization review and copying?


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 Title 21 CFR Part 11 book in PDF containing 990 requirements, which criteria correspond to the criteria in...

Your Title 21 CFR Part 11 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 Title 21 CFR Part 11 Self-Assessment and Scorecard you will develop a clear picture of which Title 21 CFR Part 11 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 Title 21 CFR Part 11 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 Title 21 CFR Part 11 projects with the 62 implementation resources:

  • 62 step-by-step Title 21 CFR Part 11 Project Management Form Templates covering over 1500 Title 21 CFR Part 11 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Probability and Impact Assessment: Are there any Title 21 CFR Part 11 projects similar to this one in existence?

  2. Risk Audit: What does internal control mean in the context of the audit process?

  3. Probability and Impact Assessment: Who should be notified of the occurrence of each of the risk indicators?

  4. Initiating Process Group: The Title 21 CFR Part 11 project managers have maximum authority in which type of organization?

  5. Cost Management Plan: Are vendor contract reports, reviews and visits conducted periodically?

  6. Monitoring and Controlling Process Group: What were things that you did very well and want to do the same again on the next Title 21 CFR Part 11 project?

  7. Change Management Plan: Has the relevant business unit been notified of installation and support requirements?

  8. Responsibility Assignment Matrix: Is the entire contract planned in time-phased control accounts to the extent practicable?

  9. Cost Baseline: Is there anything unique in this Title 21 CFR Part 11 projects scope statement that will affect resources?

  10. Schedule Management Plan: Is there any form of automated support for Issues Management?

 
Step-by-step and complete Title 21 CFR Part 11 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

  • 1.1 Title 21 CFR Part 11 project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 Title 21 CFR Part 11 project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 Title 21 CFR Part 11 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 Title 21 CFR Part 11 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 Title 21 CFR Part 11 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 Title 21 CFR Part 11 project or Phase Close-Out
  • 5.4 Lessons Learned

 

Results

With this Three Step process you will have all the tools you need for any Title 21 CFR Part 11 project with this in-depth Title 21 CFR Part 11 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose Title 21 CFR Part 11 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 Title 21 CFR Part 11 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 Title 21 CFR Part 11 investments work better.

This Title 21 CFR Part 11 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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CONTENTS:


Checklists:


Checklists:Title 21 CFR Part 11 Checklist Report on SIGNATURE.pdf

Checklists:Title 21 CFR Part 11 Checklist Report on SERVICE.pdf

Checklists:Title 21 CFR Part 11 Checklist Report on USER.pdf

Checklists:Title 21 CFR Part 11 Checklist Report on SYSTEM.pdf

Checklists:Title 21 CFR Part 11 Checklist Report on RECORD.pdf

Checklists:Title 21 CFR Part 11 Checklist Report on PROCESS.pdf

Checklists:Title 21 CFR Part 11 Checklist Report on DATA.pdf

Checklists:Title 21 CFR Part 11 Checklist Report on ORGANIZATION.pdf



STEP 1 Get your bearings:


STEP 1 Get your bearings:Title_21_CFR_Part_11_Quick_Exploratory_Self-Assessment_Guide.pdf

STEP 1 Get your bearings:Title 21 CFR Part 11 Self-Assessment Pre-Filled EXAMPLE.xlsx





STEP 2 Set concrete goals tasks dates and numbers you can track:


STEP 2 Set concrete goals tasks dates and numbers you can track:Title_21_CFR_Part_11.pdf

STEP 2 Set concrete goals tasks dates and numbers you can track:Title 21 CFR Part 11 Self-Assessment.xlsx

..and the Project Management resources in 'STEP 3: Implement, Track, follow up and revise strategy' as described above.

 

 

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