Save time, empower your teams and effectively upgrade your processes with access to this practical Computer System Validation Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Computer System 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 Computer System Validation specific requirements:
STEP 1: Get your bearings
- The latest quick edition of the Computer System 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 997 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Computer System Validation improvements can be made.
Examples; 10 of the 997 standard requirements:
- Is there a secure, computer generated, time stamped audit trail that records the date and time of operator entries and actions that create modify or delete any device or system settings?
- Have all action items initiated as a result of reviews, audits, working group and/or technical interchange meetings been closed and are the results of the closure satisfactory?
- Have critical functions been subjected to an independent verification and validation and have all identified discrepancies been satisfactorily resolved?
- What inventory related information do customers need related to the devices internal software, as versions, patch status, and known vulnerabilities?
- What would the perfect all in one software solution be required to do in order to satisfy all of the different elements of manufacturing?
- How do you quantitatively increase your confidence that a computer simulation correctly represents the underlying conceptual models?
- When a user logs in to one of your computer systems, what checks are performed other than validation of user name and password?
- Is there a procedure for electronically disabling an identification code or password if it is potentially compromised or lost?
- How do you quantitatively increase your confidence that a computer simulation is an accurate representation of the real word?
- How do you cryptographically validate the integrity and authenticity of a software update package before installation begins?
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 Computer System Validation book in PDF containing 997 requirements, which criteria correspond to the criteria in...
Your Computer System 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 Computer System Validation Self-Assessment and Scorecard you will develop a clear picture of which Computer System 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 Computer System 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 Computer System Validation projects with the 62 implementation resources:
- 62 step-by-step Computer System Validation Project Management Form Templates covering over 1500 Computer System Validation project requirements and success criteria:
Examples; 10 of the check box criteria:
- Activity Duration Estimates: Do you think many information technology professionals have experience writing RFPs and evaluating proposals for information technology Computer System Validation projects?
- Risk Audit: Have risks been considered with an insurance broker or provider and suitable insurance cover been arranged?
- Duration Estimating Worksheet: Will the Computer System Validation project collaborate with the local community and leverage resources?
- Activity Duration Estimates: Will the new application negatively affect the current IT infrastructure?
- Milestone List: Describe the concept of the technology, product or service that will be or has been developed. How will it be used?
- WBS Dictionary: Is cost and schedule performance measurement done in a consistent, systematic manner?
- Planning Process Group: Are there efficient coordination mechanisms to avoid overloading the counterparts, participating stakeholders?
- Probability and Impact Matrix: Are staff committed for the duration of the Computer System Validation project?
- Project Scope Statement: Have the configuration management functions been assigned?
- Activity List: How difficult will it be to do specific activities on this Computer System Validation project?
Step-by-step and complete Computer System Validation Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 Computer System Validation project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 Computer System 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 Computer System 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 Computer System 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 Computer System 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 Computer System 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 Computer System Validation project with this in-depth Computer System Validation Toolkit.
In using the Toolkit you will be better able to:
- Diagnose Computer System 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 Computer System 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 Computer System Validation investments work better.
This Computer System 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.