REGULATORY SERVICES

Quality Management Systems

CSSi LifeSciences offers a Quality Management Systems (QMS) that is fully compliant with the specific regulatory requirements of every major market, including the U.S., Canada, and the European Union.

Quality Systems & Audits For

Drug Quality Systems and Audits

The implementation and management of a validated QMS requires significant resources that small and emerging life science companies may not be able to obtain. Partnering with CSSi LifeSciences offers a cost-effective QMS solution.

We also regularly update your QMS in accordance with new and established FDA guidances or client related changes to processes, Standard Operating Procedures (SOPs), or Corrective Action and Preventive Action (CAPA) programs.

Most small and emerging pharmaceutical companies begin by relying on their service providers’ (e.g., CDMO, CMO, preclinical CRO, clinical CRO) Quality Management Systems (QMS).  This approach is acceptable during the initial phases of drug development and into first in human (FIH) trials. As a company develops its first product beyond FIH clinical trials and becomes a later stage clinical company, health authorities expect the company to develop their own in-house QMS.  While a virtual drug development company does not need a full 21 CFR Part 210, 211 system, certain elements are expected.

CSSi LifeSciences can assist with establishing a QMS for:

  • SOPs
  • Vendor selection and qualification
    • Vendor questionnaires
    • Vendor audits
  • Supplier management and supply agreements
  • Quality Management organizational structure
  • Training
  • Document control
  • Change management
  • Nonconformance
  • Deviation management
  • Quality Agreements
  • Process mapping and improved risk management
  • Inspection audit preparedness
  • Packaging and labeling
  • CAPA services
  • Quality manual and policy

CSSi LifeSciences also provides vendor qualification audits, FDA Pre-inspection audits, clinical site audits, and best practices to prepare for and manage an FDA or other health authority audit.

Let CSSi LifeSciences evaluate your QMS system or requirements and provide strategic guidance and support.

Medical Device Quality Systems and Audits

Our detailed and structured medical device QMS of procedures and processes harmonizes the FDA’s Quality System Regulation 21 CFR Part 820 with the ISO 13485 standard used in Europe, Korea, and the rest of the world. The CSSi LifeSciences QMS permits medical device companies to be FDA compliant for commercialization and sales. Our QMS system is scalable for Class I, Class II, or Class III medical devices in the U.S.

The QMS covers all aspects of quality systems including:

  • SOPs
  • Vendor selection and qualification
    • Vendor questionnaires
    • Vendor audits
  • Supplier management and supply agreements
  • Training
  • Document control
  • Change management
  • Risk management plans
  • Hazards analysis
  • Process mapping and improvement risk management
  • Inspection audit preparedness
  • Work instructions and forms
  • Quality manual and policy
  • Quality vendor audits and supply agreements
  • Design master file, technical files and eData storage
  • Installation of the quality system
  • CAPA services

    CSSi LifeSciences also provides vendor qualification audits, FDA Pre-inspection audits, clinical site audits, and best practices to prepare for and manage an FDA or other health authority audit.

    Let CSSi LifeSciences evaluate your QMS system or requirements and provide strategic guidance and support.

    Learn more about what sets us apart