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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
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Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
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Complaint Handling Process for MedTech and Life Science Companies
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Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
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Unlocking the Value of Complaints
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Why You Need to Digitally Transform Your QMS
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The Ultimate Guide to ISO/IEC 17025:2017 Compliance
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Safety Technology Trends to Watch in 2023 (Infographic)
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Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
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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.
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Ensuring patient safety and adhering to regulatory guidelines are key priorities in the pharmaceutical industry.
To meet safety and efficacy standards, pharmaceutical manufacturers must invest in robust QC and QA tools.
Quality Control (QC) in the pharmaceutical industry is critical to the safety, efficacy, and consistency of pharmaceutical products. It involves rigorous testing, inspections, and compliance with regulatory standards to detect and prevent defects or deviations in the manufacturing process. QC is vital in maintaining public health and safety.
Quality Assurance and Quality Control play a pivotal role for the importance of quality in Pharmaceutical Industry. Quality control (QC) and Quality Assurance (QA) are paramount in the pharmaceutical industry for several crucial reasons. QC involves systematically examining and testing pharmaceutical products at various stages of production to identify and rectify defects or variations. It ensures that each product meets the specified quality standards before reaching the market, safeguarding patient safety.
QA, on the other hand, focuses on establishing and maintaining a robust system of processes, documentation, and standards to prevent quality issues in the first place. It encompasses not only product quality but also the quality of the entire pharmaceutical manufacturing and distribution process.
Both QC and QA are essential for regulatory compliance and to gain the trust of healthcare authorities and consumers. They help mitigate the risk of product recalls, adverse events, and legal repercussions while enhancing a pharmaceutical company's reputation for reliability and integrity. In an industry where product quality directly impacts public health, QC and QA are indispensable for ensuring pharmaceuticals' safety, efficacy, and consistency.
Stringent regulatory guidelines guide quality control in pharmaceutical industry to ensure pharmaceutical products' safety, efficacy, and reliability. These guidelines are established by various regulatory bodies, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Here are some key pharmaceutical guidelines for quality control:
Customer Success
Pharmaceutical quality control involves a series of steps to ensure pharmaceutical products' safety, efficacy, and consistency. These steps are critical in meeting regulatory requirements and maintaining product quality. Here is an overview of the typical steps involved in pharmaceutical quality control:
Sampling
The process begins with the collection of samples from various stages of production, including raw materials, in-process materials, and finished products. Sampling is done according to established procedures and sampling plans.
Testing and Analysis
The collected samples undergo various tests and analyses. Depending on the product type, these may include chemical, physical, microbiological, and pharmacological tests. The tests are conducted in accordance with established testing methods and pharmacopeial standards.
Instrument Calibration
All analytical instruments and equipment used in testing must be regularly calibrated to ensure their accuracy and reliability. Calibration records are maintained to demonstrate instrument performance.
Data Recording and Documentation
Detailed test results, procedures, and observation records are meticulously maintained. Proper documentation is crucial for traceability, accountability, and regulatory compliance.
Review and Interpretation
Trained analysts review and interpret the test results, comparing them to established specifications and standards. Deviations from specifications are identified and investigated.
Out-of-Specification (OOS) Investigation
If a sample fails to meet established specifications, an OOS investigation is initiated to determine the cause of the deviation. Corrective and preventive actions (CAPA) are implemented to address the issue and prevent recurrence.
Stability Testing
Stability studies evaluate how the product changes over time under different storage conditions. This helps determine shelf-life and appropriate storage recommendations.
Documentation Review
Quality control personnel review all data and documentation to ensure compliance with established procedures and regulatory requirements.
Release or Reject Decision
Based on the review of testing data, products are either released for distribution if they meet specifications or rejected if they do not. The release decision is made by qualified personnel.
Record Keeping
All quality control records, including test results, batch documentation, and investigations, are archived and maintained for a specified period, as regulatory authorities require.
Reporting
Quality control may generate reports summarizing testing results, OOS investigations, and other relevant information. These reports can be shared with regulatory agencies as required.
Continuous Improvement
The quality control process includes feedback mechanisms to improve processes and prevent future quality issues continually.
We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.
Helen Cary,Document Control Specialist
General Quality Control and Assurance Points for ATMPs
Checklist | March 29th, 2022
Manufacturing Quality Control Checklist
Checklist | July 24th, 2023
Out of specification (OOS) results in pharmaceutical quality control trigger a rigorous investigation process. The first step is to confirm the OOS result through retesting, and if the result is still OOS, an investigation is initiated. This investigation aims to determine the cause of the deviation, whether related to the product, equipment, methods, or personnel. Corrective and preventive actions (CAPA) are then implemented to address the issue, prevent recurrence, and ensure product quality. Throughout this process, detailed documentation is maintained, and regulatory agencies are notified if required. OOS investigations are critical to maintaining the safety and efficacy of pharmaceutical products.
The ComplianceQuest solution quality management in pharmaceutical industry fosters transparency and collaboration across the enterprise to manage quality initiatives and compliance processes. It seamlessly interfaces with a company's internal systems, such as ERP, MES, LIMS, HR, and PLM, ensuring that compliance and quality are integral throughout the product lifecycle. This integration optimizes information management, offering unparalleled visibility into all facets of compliance across your product value chain.
What sets ComplianceQuest apart is its seamless integration of quality and compliance processes and data, delivering incremental value and enhancing operational excellence, thus promoting continuous improvement and growth. Instant access to precise reporting and analytics aids in identifying trends and patterns throughout the organization, leading to faster and more predictable results. This insight provides a strategic advantage, enabling a proactive approach to mitigating quality and compliance risks.
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One of our customers is a leading manufacturer of specialty chemicals. To produce these chemicals, the company uses vegetable oils…
