Description

Know the record will still function the way it was supposed to when created using the software

Does your organization have adequate hardware and software resources available to conduct an audit of electronic records?

What sampling techniques and methods Are used in place of a detailed review of all records for the audit period?

What controls should be in place to ensure original electronic data is preserved?

What steps will be taken to provide for image and index data back up?

What do records help your organization to do?

...Find the answers to these, and more, questions with this Electronic Batch Records Toolkit:

Become your organization Records Officer.
Get records out of your office.
Avoid maintaining data in multiple places across your business, MES and automation systems.
Build staff awareness and compliance with web content archiving procedures.
Find out what your organization schedules are.
Convert Word files into FAP files.
Create multiple CAR files and CAR paths.
Assure that the material that will ultimately be used in product for human use is safe considering many exemptions as considered about validation.
Ensure that only fit for purpose equipment will be used throughout production.

HOW THIS TOOLKIT WORKS:

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

STEP 1: Get your bearings

Start with...

The latest quick edition of the Electronic Batch Records 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 Electronic Batch Records improvements can be made.

Examples; 10 of the 990 standard requirements:

Are organizations expected to have a product development report to identify the critical steps and critical parameters of the process to yield an acceptable product and limit impurities?
Are the owners of the oxygenate blending facility expected to register as an oxygenate blender or is the owner of the product being blended expected to register as an oxygenate blender?
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?
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?
What is the expectation on performing process validation without the qualification or validation of utilities that are in contact with the product?
When you perform a process validation, should the equipment instruments be calibrated immediately after the completion of the validation runs?
When assessing if a change has had an affect on product quality, what criteria are used to evaluate any change in the impurity profile?
What are the interfaces between different systems if you change the tool used to manage one process, how does it impact the others?
How can a distinctive batch or receipt number be meaningful for purposes of tracking materials used in a specific production batch?
Can process deviations be used to expand the validation critical process parameter ranges, for one deviation, multiple deviations?

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 Electronic Batch Records book in PDF containing 990 requirements, which criteria correspond to the criteria in...

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

62 step-by-step Electronic Batch Records Project Management Form Templates covering over 1500 Electronic Batch Records project requirements and success criteria:

Examples; 10 of the check box criteria:

Quality Audit: How does your organization know that its system for recruiting the best staff possible are appropriately effective and constructive?
Activity Duration Estimates: Why is there a growing trend in outsourcing, especially in the government?
Stakeholder Analysis Matrix: Does your organization have bad debt or cash-flow problems?
Team Performance Assessment: Can team performance be reliably measured in simulator and live exercises using the same assessment tool?
Lessons Learned: Was the purpose of the Electronic Batch Records project, the end products and success criteria clearly defined and agreed at the start?
Requirements Traceability Matrix: Is there a requirements traceability process in place?
Project or Phase Close-Out: What information did each stakeholder need to contribute to the Electronic Batch Records projects success?
Team Member Performance Assessment: What were the challenges that resulted for training and assessment?
Stakeholder Analysis Matrix: What mechanisms are proposed to monitor and measure Electronic Batch Records project performance in terms of social development outcomes?
Requirements Management Plan: Which hardware or software, related to, or as outcome of the Electronic Batch Records project is new to your organization?

Step-by-step and complete Electronic Batch Records Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

1.1 Electronic Batch Records project Charter
1.2 Stakeholder Register
1.3 Stakeholder Analysis Matrix

2.0 Planning Process Group:

2.1 Electronic Batch Records project Management Plan
2.2 Scope Management Plan
2.3 Requirements Management Plan
2.4 Requirements Documentation
2.5 Requirements Traceability Matrix
2.6 Electronic Batch Records 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 Electronic Batch Records 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 Electronic Batch Records 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 Electronic Batch Records 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 Electronic Batch Records project with this in-depth Electronic Batch Records Toolkit.

In using the Toolkit you will be better able to:

Diagnose Electronic Batch Records 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 Electronic Batch Records 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 Electronic Batch Records investments work better.

This Electronic Batch Records 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:

Checklists:Electronic Batch Records Checklist Report on VALIDATION.pdf

Checklists:Electronic Batch Records Checklist Report on INFORMATION.pdf

Checklists:Electronic Batch Records Checklist Report on DATA.pdf

Checklists:Electronic Batch Records Checklist Report on RECORD.pdf

Checklists:Electronic Batch Records Checklist Report on PRODUCT.pdf

Checklists:Electronic Batch Records Checklist Report on AUDIT.pdf

Checklists:Electronic Batch Records Checklist Report on SYSTEM.pdf

Checklists:Electronic Batch Records Checklist Report on PROCESS.pdf

Checklists:Electronic Batch Records Checklist Report on MANAGEMENT.pdf

Checklists:Electronic Batch Records Checklist Report on ORGANIZATION.pdf

Checklists:Electronic Batch Records Checklist Report on FILE.pdf

STEP 1 Get your bearings:

STEP 1 Get your bearings:Electronic Batch Records Self-Assessment Pre-Filled EXAMPLE.xlsx

STEP 1 Get your bearings:Electronic_Batch_Records_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:Electronic_Batch_Records.pdf

STEP 2 Set concrete goals tasks dates and numbers you can track:Electronic Batch Records Self-Assessment.xlsx

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

Who This Toolkit Is For

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Tried:

What have you tried so far to fix this? Is there pain of frustration to solve this all on your own?

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What is stopping you from achieving this all on your own without any help? If your answer is one of these three answers, this Toolkit is right for you:

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Electronic Batch Records Toolkit