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Quality from Bench to Bedside to Benefit

Ensure compliance for cell and gene therapies with ComplianceQuest, a next generation, AI-powered quality and safety platform built on Salesforce

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cell and gene industry
Cell and Gene Therapy

Reducing the Risks of Advanced Therapy Manufacturing

From constantly evolving technologies to highly complicated supply chains, advanced therapy manufacturing comes with its unique set of quality challenges:

  • Comprehensive GMP Documentation
  • Complicated Supply Chains
  • Rigorous Training Requirements
  • Multiple Site Audits
  • Extensive Risk Assessment

As you move from basic therapy research to the clinic, and later on to commercialization, it is vital you ensure process consistency, product quality and proper documentation throughout the manufacturing process.

However, relying on a paper-based quality management system only makes compliance harder.

That’s why you need a modern QMS system that helps you ensure quality, consistency and reliability through every step from patient sample collection, to transportation, to manufacturing all the way back to the patient.

Lay the Foundation for Regulatory Approval with Built-in Compliance

Maintaining proper documentation is key to regulatory approval. However, keeping track of equipment logs, work instructions, SOPs, trainings, or traceability documents can become extremely challenging especially with a paper-based system.

ComplianceQuest helps you ensure ATMP, FDA and EU compliant documentation for traceability, analytical methods, work instructions, material inspections, trainings and more. Benefit from a modern Document Management solution that supports document collaboration and teamwork with Microsoft Office and Google Suite Integrations.

Instill Quality Standards Across Facilities, Sites and Clinics

Reducing risks and maintaining quality means performing site feasibility and regular audits of both internal facilities and clinics for GMP compliance and inspection readiness. This can be time-consuming, hard to manage and not to mention it can place an extra burden on already pressured teams.

With ComplianceQuest you can maintain GMP standards across internal sites and clinics with guided audit management and site feasibility studies. ComplianceQuest’s Audit Management solution allows you to automatically follow up on audit findings and escalate to CAPA when necessary to ensure inspection readiness.

Get Clear Oversight of Your Supply Chain and Collaborate with Suppliers in Real-time

Developing advanced therapies means dealing with sophisticated logistics, strict time restraints, material variability and cold chain management of sensitive material. A solid QMS is needed to evaluate each element of the supply chain through operational, quality and compliance perspectives.

The Supplier Management module from ComplianceQuest helps you better manage your supply chain so you can stay on top of time-sensitive and temperature-critical logistics with digital supply chain management. You will also be able to collaborate in real-time with everyone involved in the supply chain with the Supplier Portal, to make sure patients are getting their therapies on time.

Prepare Commercial Scale-up With Standardization and Embedded Risk Management

Only by evaluating and mitigating every risk in the manufacturing processes can we guarantee that patients receive a safe and effective therapy every time. But developing a compliant and successful risk-based process requires a data-driven approach, which can be limited with a paper-based system.

With built-in best-in-class workflows, you can standardize and automate your cGMP processes and general process validation concepts. With ComplianceQuest’s, Risk Management is embedded in every solution so you can Identify and mitigate manufacturing risks associated with batch-of-one production with a reliable and well-documented risk-based approach.

Provide Needed Safety and Quality Trainings to Personnel and HCPs

Producing Cell and Gene therapies under GMP cleanroom facilities, with a focus on product safety, quality and consistency requires tremendous expertise. All personnel involved in the process must be properly trained, including personnel in clinical sites.

ComplianceQuest empowers you to manage required cGMP and safety personnel trainings to all personnel and healthcare professionals involved in the process globally with ease, through mobile-friendly cGMP and Safety training videos.

Solve Quality Issues Faster and Drive Continuous Improvement of Your Processes

Catching and addressing quality issues is vital in guaranteeing product quality and patient safety, especially for advanced therapies where product lifecycles are short and time is of the essence. Paper-based systems are not agile by design and stand in the way of proper quality control and quality assurance.

ComplianceQuest provides CAPA, non-conformance and complaint management solutions to take your Quality Control efforts to the next level. The connected suites allow you to leverage CAPAs to drive continuous improvement of your processes and improve QC with faster identification and resolution of quality issues.

Regulations Addressed

GMP:

  • ATMP guidelines: Advanced Therapies Manufacturing Practices
  • ISPE GAMP 5: Risk-Based Approach to Compliant GxP Computerized Systems (CSV-validation)

FDA:

  • 21 CFR Part 600: Biological Products: General
  • 21 CFR Part 606: Current Good Manufacturing Practice for Blood and Blood Components
  • 21 CFR Part 610: General Biological Product Standards
  • 21 CFR Part 630: Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
  • 21 CFR Part 1271: Human Cells, Tissues, and Cellular and Tissue-Based Products
  • ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology

EU:

Related Insights

The 3-minute Quality Score Quiz for Cell & Gene Therapy Companies

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