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The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
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
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Frost Radar for Quality Management Systems Names ComplianceQuest Leader
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The Ultimate Guide to Next-Generation Supplier Management [e-Book]
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Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
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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.
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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 quality, safety and efficiency as they bring their products from concept to customer success.
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In industries such as pharmaceuticals, biotechnology, and medical devices, GxP compliance is essential to maintain product quality, safety, and data integrity. It refers to adherence to a set of guidelines and regulations, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP), that ensure the safety and efficacy of products. These standards are critical to ensure that products are safe for consumers, meeting the regulatory requirements of the Food and Drug Administration (FDA) and other global authorities.
The primary goal of GxP compliance is to safeguard consumers by ensuring that products meet strict safety standards. For businesses in these industries, understanding and implementing GxP is key to ensuring regulatory readiness, reducing risk, and building trust with both regulators and customers alike.
GxP covers a wide range of compliance-related activities across different sectors:
G stands for Good, referring to the quality standards that need to be met in manufacturing, clinical trials, and laboratory settings.
x is a variable representing the type of practice (e.g., Manufacturing or Clinical).
P stands for Practices, referring to the specific guidelines and procedures to be followed.
For industries such as pharmaceuticals, biotechnology, and medical devices, following these practices ensures that the products developed are safe, effective, and compliant with regulatory standards. These industries rely on GxP not only for compliance but also to achieve consistent product quality and minimize risks across their operations.
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GxP compliance stands for Good [x] Practices compliance, ensuring that the product under development meets requirements and is fit for the intended purpose. Applying relevant GxP process regulations is necessary for highly regulated industries. There are different sectors that may need to use different practices, but these are the most popular ones:
GMP addresses issues around cleanliness, valid process usage, handling complaints, sanitation, hygiene, record keeping, and personnel qualifications, and takes the necessary proactive measures to ensure the safety, purity, and effectiveness of its products. GMP guidelines allow manufacturers to understand how to implement them in their specific environments.
GAMP is the automated version of GMP, which guides companies in taking a risk-based approach to creating scalable, verifiable computerized systems while achieving or maintaining compliance with regulations.
GCP is a global standard by the International Conference on Harmonization (ICH), which focuses on the moral aspects of clinical trials, stipulating that the interests of corporations are not to be prioritized above human life in clinical trials where human subjects are involved.
GCP enables companies to follow particular protocols to ensure that subjects’ wellbeing, rights, and safety don’t get infringed. All potential risks have to be resolved and measured against the possible benefits.
GLP requirements are designed to ensure the repeatability, uniformity, reliability, quality, and integrity of human or animal health products via non-clinical safety tests in research labs.
The key principles of GLP are the following:
GDP is the minimum standard that a wholesale distributor must meet to ensure that the quality and integrity of medicines are maintained throughout the supply chain.
Conforming to GDP ensures the following:
The best solution for achieving compliance by applying the above principles is using a holistic QMS that enables the use of workflows in a modern and shared work environment and can also automate the process documentation. This results in minimizing human error which is the primary cause of failure at audits.
GxP compliance is divided into five main elements. The ‘5 Ps’ are:
People
Procedures
Products
Premises & equipment
Processes
We implemented ComplianceQuest (CQ) to replace our previous Complaint Management System. From the very first day, CQ went above and beyond to help provide expertise on how to automate our business processes in CQ, providing insight into how to properly migrate data to CQ, all while ensuring that our new processes were FDA compliant. They worked day and night to ensure our requirements were met. Beyond the incredible amount of support that CQ provided, their Complaint Management solution is extremely user friendly with a wonderful UI. Since moving to CQ we have received nothing but great feedback from our complaint handling users especially around productivity gains. Great people, Great product, and Great Service. I highly recommend ComplianceQuest to all.
Jamal Austin,Project Manager / Business Analyst, Livongo
FDA Compliance complies with a rule, such as a policy, standard, or law stated by the US government. FDA compliance guidelines are essential for researchers working on clinical trials and marketing professionals, and are continually evolving to reflect new technologies. Achieving regulatory compliance requirements is crucial for every business as it complies with regulations set out by regulatory bodies. Businesses in the pharmaceutical, medical device, and healthcare industries gain the following benefits:
Mitigates Risk:
The major benefit of compliance with the regulatory requirements is when organizations can mitigate, identify, and eliminate risk at all stages Risk mitigation is one of the key purposes of regulatory compliance while regulatory agencies provide a complete guideline that acts as a ready reference for organizations to identify and mitigate risks.
Improves Customer and Investor Confidence:
Gaining trust from across the board, right from the customers, stakeholders, employees and investors, can be challenging but made possible by complying with regulatory requirements, the greatest guarantee and safeguard for the efficiency and efficacy of a product.
Reduces Costs:
Another benefit of FDA compliance with regulatory requirements is saving costs throughout the product lifecycle. If any product fails to pass regulatory requirements and the test of regulatory approval, they have to meet the penalty requirements of the FDA or other regulatory agencies. So, meeting regulatory compliance requirements at every stage is very important and more economical.
This major benefit of compliance with the regulatory requirements is when organizations can mitigate, identify, and eliminate risk at all stages. Risk mitigation is one of the key purposes of regulatory compliance while regulatory agencies provide a complete guideline that acts as a ready reference for organizations to identify and mitigate risks.
Ensuring Quality in Pharmaceutical Manufacturing: 4 CGMP Checklists to Follow
Checklist | April 26th, 2023
CGMP for Finished Pharmaceuticals – Control of Components and Drug Product
Checklist | November 29th, 2021
GxP compliance is crucial as it ensures that:
Products are safe for consumers.
The integrity of data used for safety decisions is maintained.
The likelihood of product recalls is significantly reduced.
Protects public health by verifying product reliability.
GxP compliance includes adhering to:
Proper documentation practices.
Comprehensive personnel training.
Accurate recording, handling, and storing of data.
Confidentiality of records.
Accountability and traceability in data and documentation.
A defined software development lifecycle (SDLC) process.
Robust data integrity and security controls.
Maintenance of training records.
Ensuring GxP compliance requires strict adherence to data integrity, validation, security, and accountability across GMP, GLP, GCP, and GDP. Key best practices include:
Training & Documentation: Provide GxP training, maintain traceable records, and follow Good Documentation Practices (GDP) with ALCOA+ principles.
Data Integrity & Security: Implement audit trails, role-based access controls, and electronic recordkeeping to prevent data manipulation.
Validation & SOPs: Validate manufacturing equipment, laboratory instruments, and software systems while maintaining Standard Operating Procedures (SOPs).
Audits & CAPA: Conduct regular audits and implement Corrective and Preventive Actions (CAPA) to address compliance gaps.
Regulatory Compliance: Follow GMP for manufacturing, GLP for labs, GCP for clinical trials, and GDP for supply chain traceability.
GxP is a comprehensive framework of regulatory guidelines ensuring product safety, quality, and efficacy across the life sciences industry, while GMP (Good Manufacturing Practice) is a specific subset of GxP focused solely on manufacturing processes for pharmaceuticals, medical devices, and other healthcare products.
GxP (Good [x] Practices): Encompasses multiple regulatory guidelines, including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). It ensures compliance at every stage, from research and clinical trials to manufacturing and distribution.
GMP (Good Manufacturing Practice): Falls under the GxP framework but focuses strictly on manufacturing, ensuring that products are consistently produced and controlled according to predefined quality standards. It emphasizes validated processes, proper documentation, and trained personnel to prevent errors and maintain quality.
Key Differences: GxP vs. GMP
GxP governs the entire product lifecycle – from research to distribution.
GMP focuses specifically on manufacturing, ensuring consistency, safety, and compliance during production.
Both are essential for regulatory compliance, helping to prevent risks, ensure product integrity, and safeguard public health.
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