Save time, empower your teams and effectively upgrade your processes with access to this practical GMP Certified Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any GMP Certified 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 GMP Certified specific requirements:
STEP 1: Get your bearings
- The latest quick edition of the GMP Certified 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 905 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which GMP Certified improvements can be made.
Examples; 10 of the 905 standard requirements:
- How are you ensuring that the quality policy and quality objectives are established for the QMS and are compatible with the strategic direction and the context of your organization?
- Do you have a system for obtaining your customers review and disposition of all nonconforming materials that cannot be reworked to customer requirements or are deemed obvious scrap?
- How will introduction of testing affect the current work flow, are there sufficient personnel to conduct testing, and how will they be trained and maintain testing competency?
- Is documented information (required by the QMS and ISO 9001) controlled to ensure it is adequately protected from loss of confidentiality, improper use, or loss of integrity?
- How do you educate staff to understand why the hazard and risk management controls in areas are so important, and what would be the consequences of not following them?
- Has top management defined and communicated to your organization the responsibilities and authorities of stakeholders involved in the effective operation of the QMS?
- The key factors to consider when a facility encounters power outage are time and temperature. How long was the power out, and what were the resultant temperatures?
- Auditors should look at these requirements in light of the organization s QMS scope -how will these requirements impact the QMS ability to fulfill this scope?
- Has your organization established, documented, implemented and maintained a QMS and continually improved its effectiveness in accordance with ISO 9001:2008?
- Do you require, document and obtain corrective action from your suppliers for nonconforming materials, parts or services or unsatisfactory performance?
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 GMP Certified book in PDF containing 905 requirements, which criteria correspond to the criteria in...
Your GMP Certified 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 GMP Certified Self-Assessment and Scorecard you will develop a clear picture of which GMP Certified 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 GMP Certified 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 GMP Certified projects with the 62 implementation resources:
- 62 step-by-step GMP Certified Project Management Form Templates covering over 1500 GMP Certified project requirements and success criteria:
Examples; 10 of the check box criteria:
- WBS Dictionary: Are authorized changes being incorporated in a timely manner?
- Executing Process Group: Based on your GMP Certified project communication management plan, what worked well?
- Lessons Learned: What was the geopolitical history during the origin of your organization and at the time of task input?
- Responsibility Assignment Matrix: Does the scheduling system identify in a timely manner the status of work?
- Procurement Audit: Is it clear which procurement procedure your organization has opted for?
- Human Resource Management Plan: Are changes in deliverable commitments agreed to by all affected groups & individuals?
- Assumption and Constraint Log: Can the requirements be traced to the appropriate components of the solution, as well as test scripts?
- Cost Baseline: Has the actual cost of the GMP Certified project (or GMP Certified project phase) been tallied and compared to the approved budget?
- Lessons Learned: How actively and meaningfully were stakeholders involved in the GMP Certified project?
- Executing Process Group: Will additional funds be needed for hardware or software?
Step-by-step and complete GMP Certified Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 GMP Certified project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 GMP Certified project Management Plan
- 2.2 Scope Management Plan
- 2.3 Requirements Management Plan
- 2.4 Requirements Documentation
- 2.5 Requirements Traceability Matrix
- 2.6 GMP Certified 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 GMP Certified 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 GMP Certified 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 GMP Certified project or Phase Close-Out
- 5.4 Lessons Learned
With this Three Step process you will have all the tools you need for any GMP Certified project with this in-depth GMP Certified Toolkit.
In using the Toolkit you will be better able to:
- Diagnose GMP Certified 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 GMP Certified 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 GMP Certified investments work better.
This GMP Certified 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.