Join ConQuest 2025 | ComplianceQuest User Conference | April 8–10, Clearwater Beach, FL
Discover your potential savings with our ROI Calculator
Product Lifecycle Management
Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Complaints Management
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Risk Management
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Supplier Management
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Safety Management
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Environment and Sustainability
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
Make it easy for your people to manage, track and analyze environmental and sustainability metrics
Bring higher quality products to market quicker with design controls, projects & DHF
Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
Strategically manage the complete lifecycle of your product
Efficient Waste Management for Compliance & Sustainability
Relevant Information within reach - Always.
Assuring Quality Products and Services
Self-guided Product Tours
Product Demo Videos
Pricing
ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
Salesforce
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
CQ Platform
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
Recent Blogs
Recent Infographics
Recent Case Studies
Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
Recent Checklists
Featured Checklist
Complaint Handling Process for MedTech and Life Science Companies
Course Offerings
Recent CQ Guides
Featured CQ Guide
Datasheets
Brochures
Demo Center
Podcasts
Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Videos
Recent Webinars
Webinar
Unlocking the Value of Complaints
Recent Whitepapers
Whitepaper
Why You Need to Digitally Transform Your QMS
Recent Compliance
Compliance
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
Recent Toolkits
Featured Toolkit
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
Events and Webinars
Events
Upcoming Webinars
Featured Event
Interphex
01 Apr, 2025
New York, NY
About
About ComplianceQuest
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase product, quality, safety, and supplier as they bring their products from concept to customer success.
Meet the Leadership Team
Careers
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Corporate Citizenship
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
Customers & Testimonials
Newsroom
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
Change Control is a systematic and structured process employed across various industries to manage modifications or alterations to a project, system, or process.
It ensures that changes are implemented in a controlled and organized manner, minimizing risks, preventing disruptions, and maintaining the overall integrity of the entity undergoing modification. Change control is particularly prominent in project management, regulatory environments, and quality management systems.
In project management, Change Controls involves a series of steps, including the identification of proposed changes, their assessment for potential impacts on scope, schedule, and budget, obtaining approvals from relevant stakeholders, and implementing approved changes in a controlled manner. This process prevents unauthorized modifications, commonly called scope creep, and helps maintain project focus.
Change control is crucial in regulated pharmaceuticals, healthcare, and manufacturing industries. For example, Good Manufacturing Practice (GMP) mandates that any changes proposed or implemented to processes, equipment, or materials must undergo a rigorous control change process to ensure product quality and safety are consistently upheld. This includes assessing the impact of changes, obtaining approvals, and documenting the entire process for regulatory compliance.
Integrated Change Control is essential for maintaining project control, preventing scope creep, and ensuring that changes contribute positively to project…
The main difference is Change Control focuses on technical aspects, Change Management addresses the human and cultural aspects. Both are…
Maintaining compliance with industry standards and managing changes effectively is crucial in the highly regulated and competitive automotive industry. Our…
The five steps of a change control process are:
The benefits of a Change Control Process in project management are numerous and play a crucial role in ensuring the success and stability of projects. Here's an elaboration on the listed benefits:
A Control Change Process helps prevent unmanaged changes or scope creep. By formalizing, evaluating, and implementing changes, teams can stay focused on the original project objectives, avoiding unnecessary disruptions and ensuring that resources are used efficiently.
Clear communication is essential in project management, especially when changes are involved. A structured Change Control Process facilitates effective communication by defining how changes are identified, assessed, and communicated to relevant stakeholders. This reduces the risk of misunderstandings.
The Change Control Process includes project managers, team members, and decision-makers. Collaborative decision-making ensures that changes are thoroughly evaluated from different perspectives, leading to better-informed decisions. This collaborative approach fosters teamwork and a shared responsibility for project outcomes.
Change Controls in project management refers to the systematic process of managing changes to the project scope, schedule, or other project elements in a controlled and organized manner. It involves identifying, evaluating, approving, and implementing changes while minimizing potential negative impacts on the project.
Key Components of Change Control in Project Management:
Any proposed change to the project, whether it involves scope, schedule, or other elements, needs to be formally identified. This could come from various sources, including stakeholders, team members, or external factors.
The proposed change is assessed for its impact on the project. This involves evaluating how the change may affect the project scope, timeline, budget, and other key parameters.
Changes are presented to relevant stakeholders, and approval is sought based on the assessment. Depending on the project's governance structure, this could involve project sponsors, clients, or other decision-makers.
Once approved, the change is implemented in a controlled manner. This includes updating project plans, communicating changes to the team, and ensuring the project remains on track.
Documentation is crucial throughout the change control process. Changes, assessments, approvals, and implementations are documented to maintain a clear record. Communication ensures that all stakeholders are informed of changes and their implications.
Examples of Change Control Processes:
A Change Control Process should be used in various scenarios to manage modifications to a project, product, or system in a structured and controlled manner. Here are some key situations when it is appropriate to employ a Change Control Process:
Changes in Project Scope
When there is a proposed alteration to the project scope, including additions, removals, or modifications to project deliverables.
Timeline Adjustments
When there is a need to change project timelines, deadlines, or milestones due to unforeseen circumstances or evolving project requirements.
Budgetary Changes
When there are adjustments to the project budget, including changes in resource allocation, funding, or financial constraints.
Quality Modifications
When changes are proposed that may impact the quality of the final product or service, ensuring that quality standards are maintained or improved.
Risk Mitigation
When there is a need to address identified risks or mitigate potential issues that could affect the project's success.
Stakeholder Requests
When stakeholders, clients, or end-users request modifications to the project that were not initially included in the plan.
Regulatory Compliance
When changes are required to ensure compliance with new regulations or standards affecting the project.
Technology or Process Changes
When there are proposed alterations to the technology, tools, or processes used in the project or organization.
Environmental Factors
When external factors such as market conditions, industry trends, or geopolitical events necessitate adjustments to the project.
Error Correction
When errors or issues are identified during project execution, corrections or modifications are needed to rectify these issues.
Client Feedback
When clients provide feedback or request changes based on evolving needs or preferences.
Resource Constraints or Availability
When there are changes in resource availability or constraints that necessitate adjustments to the project plan.
Change control is of paramount importance in Good Manufacturing Practice (GMP) as it ensures the systematic management of modifications to processes, equipment, facilities, and systems within the pharmaceutical and medical device industries. Strict adherence to GMP principles is vital for consistently producing high-quality and safe products. Change control is critical because any manufacturing process or procedure alterations can significantly impact product quality, safety, and efficacy. By implementing a robust change control process, organizations in GMP-regulated industries can thoroughly assess proposed changes, identify potential risks, and ensure that modifications align with established quality standards. This systematic approach minimizes the likelihood of unintended consequences, deviations from regulatory requirements, and compromises in product quality.
Additionally, change control in GMP facilitates proper documentation, traceability, and transparency, all of which are essential for regulatory compliance and maintaining the integrity of the manufacturing process. Effective change control in GMP ultimately safeguards product quality, regulatory compliance, and patient safety throughout the product lifecycle.
A Change Request Form is needed to formalize and document proposed changes. It provides a structured format for capturing essential details such as the nature of the change, reasons for the change, potential impacts, and the individuals responsible for the request. This form serves as a starting point for the change control process.
There are various types of Change Request Forms, and the specific type used depends on the nature of the change. Examples include:
Scope Change Request Form
Used for changes affecting project scope.
Schedule Change Request Form
Used for changes impacting project timelines.
Budget Change Request Form
Used for changes affecting project budget.
Quality Change Request Form
Used for product or service quality changes.
These forms help standardize the information captured during the change request initiation, making assessing and managing changes easier.
I’ve been using ComplianceQuest (CQ) for about 9 months and am extremely pleased with the product, the implementation team and ongoing support.
I selected CQ for a number of reasons. Functionality and a simple user interface were key requirements. CQ has all the functionality needed in support of a global QMS. Implementation includes; Document control, change order, personnel training, NC/CAPA, equipment management, supplier management, audit management, and customer complaints all on a single platform. As a small biologics company it was critical to find a single solution to meet our GMP quality system requirements. We wanted a cloud-based system, that would be quick to implement, that could be expanded globally and in other languages, all for a reasonable price. The user interface – it is exactly what I was hoping for. I constantly hear the staff saying, “I love CQ, it’s so straightforward to use”.
Donna Matuizek,Sr. Director Quality
A Change Control Policy is a set of documented guidelines and procedures that an organization follows to manage and control changes to its systems, processes, projects, or other regulated entities. A Change Control Policy aims to ensure that changes are implemented in a planned and systematic manner, minimizing the potential for disruptions, errors, or negative impacts on the organization's operations. It is a critical component of quality management and is often associated with IT, software development, and project management processes.
Here is a basic change control policy template:
Purpose
The purpose of this Change Control Policy is to establish guidelines and procedures for managing and controlling changes to [organization's name] systems, processes, and projects to ensure the integrity, stability, and reliability of our operations.
Scope
This policy applies to all changes, including but not limited to, hardware, software, procedures, documentation, and organizational structure, that may impact the company.
Change Request Submission
All proposed changes must be submitted through the designated Change Request form. The form should include details such as the nature of the change, the reason for the change, potential impacts, and the proposed implementation plan.
Change Evaluation
The Change Control Board (CCB) will evaluate the proposed changes. The CCB will assess the change's impact, risks, and benefits before approval.
Change Approval
Approved changes will be documented, and stakeholders will be informed. The CCB will ensure that necessary resources are allocated to implement approved changes.
Change Implementation
Changes will be implemented according to an approved plan. A rollback plan should be in place if unexpected issues arise during implementation.
Documentation
Comprehensive documentation of all changes, including reasons, approvals, and implementation details, will be maintained.
Communication
Effective communication will be maintained throughout the change process to inform stakeholders of progress and potential impacts.
Monitoring and Review
The effectiveness of implemented changes will be monitored, and a post-implementation review will be conducted to identify lessons learned and areas for improvement.
Roles and Responsibilities
Define the roles and responsibilities of individuals involved in the change control process, including the Change Control Board, change initiators, and those responsible for implementation.
Revision History
This policy will be periodically reviewed and updated as necessary. A revision history will be maintained.
A Change Control Process Template is a structured and predefined document that outlines the steps and procedures to be followed when managing changes within a project, system, or process. This template serves as a guide to ensure that changes are systematically evaluated, approved, and implemented in a controlled and organized manner. The specific contents of a Change Control Process Template may vary, but typically, it includes the following key elements:
Change Request Identification
Clearly defines the process for initiating a change request, including information such as the requester's details, a description, and the reason for the proposed modification.
Change Request Evaluation
Outlines the criteria and considerations for evaluating the impact and feasibility of the proposed change. This may involve assessing the potential effects on scope, schedule, budget, and other relevant factors.
Change Approval Workflow
Defines the workflow for obtaining approvals at different levels. This includes identifying the individuals or groups responsible for reviewing and approving or rejecting the change request.
Documentation Requirements
Specifies the documentation needed to support the change control process. This may include updated project plans, revised requirements, and other relevant documentation.
Implementation Plan
Details the steps to implement the approved change. It may include instructions for updating documentation, notifying stakeholders, and conducting testing, among other activities.
Communication Plan
Outlines how communication about the change will be managed. This includes informing relevant stakeholders, team members, and other parties affected by the change.
Monitoring and Reporting
Describes the mechanisms for monitoring the implementation of the change, tracking its progress, and reporting status updates to relevant parties.
Change Closure
Specifies the criteria for closing a change request, ensuring that all necessary documentation is updated and stakeholders are notified of the successful implementation.
Clearly define the roles and responsibilities of individuals involved in the change control process. This ensures accountability and clarity in decision-making.
References and Attachments
Provides relevant references, templates, or attachments supporting the change control process.
A Change Control Process Template serves as a standardized tool for managing changes efficiently and maintaining control over project or process modifications. It helps ensure that changes are thoroughly evaluated, approved by the appropriate stakeholders, and implemented in a manner that minimizes disruptions and risks. Organizations often customize these templates to align with their specific processes and requirements.
ISO 13485 and ISO 9000 are international standards that guide quality management systems in different industries. ISO 13485 focuses on the medical device industry, while ISO 9000 is a more general standard applicable to various sectors.
In the context of the FDA (Food and Drug Administration) regulations for medical devices, 820.30, 820.40, and 820.70 correspond to specific sections within Title 21 of the Code of Federal Regulations (CFR) Part 820, which is commonly known as the Quality System Regulation (QSR) for medical devices. These sections are part of the requirements outlined by the FDA for manufacturers to ensure the Quality and Safety of medical devices.
Streamlining Change Order Process in Product Development Product development is an iterative process. From the design stage to final packaging…
The design and development of a product is a dynamic…
In today’s competitive environment, product companies including those in regulated…
Adapting to changes, evolving, and being agile have become essential…
Learn about all features of our Product, Quality, Safety, and Supplier suites. Please fill the form below to access our comprehensive demo video.
Please confirm your details
By submitting this form you agree that we can store and process your personal data as per our Privacy Statement. We will never sell your personal information to any third party.
