GxP and Medical Device Compliance Services

Quality Assurance (QA) Services

We provide our clients with GxP and GMP services including auditing, inspection preparation, Raw Data Handling, Inspection remediation and QA support

 

Quality Assurance

Product quality issues can happen at any step of the manufacturing, compounding, testing, holding, and distribution process. An independent quality assurance unit that provides independent oversight over the final disposition of manufactured material is required by our clients. Therefore,  it is essential for companies to identify discrepancies based on risk through optimized quality systems and thorough batch quality audits and respond to them.

Consultys Quality Assurance Experts ensure our clients’ products are consistent and safe; whether they are manufactured at a pharmaceutical or device manufacturing facility, or compounded directly at an accredited compounding pharmacy.

 

Quality Management System 

Quality Management Systems meet the requirements of managing and maintaining a company’s quality system. It is a formalized business practice that defines management responsibilities for organizational structures, processes, procedures, and the resources needed to fulfill product and service requirements, customer satisfaction, and continuous improvement. 

With solutions catered for both start-up firms and established companies, Consultys is capable of supporting your organization’s unique needs. Start-up firms utilize Consultys to develop quality systems that include policies and standard operating procedures (SOPs) necessary to implement the framework of their quality program. Established companies come to Consultys for help in order to optimize their procedures that best reflect industry practice or regulatory expectations.
 

Supplier Management Services

All drug, device, pharmacy, biologics, and dietary supplement manufacturers purchase raw materials, components, and services from external suppliers. A company’s supplier is considered an extension of the firm, and therefore it is each company’s responsibility to make sure that their suppliers conform to various quality standards. For many organizations, this additional management requirement can be easily overlooked considering the mounting requirements for internal operations alone.

Consultys offers supplier management services, which include quality agreement implementation and management, man-in-plant oversight, quality oversight and approval of applicable GMP system, and auditing in order to verify not only that suppliers meet the minimum quality standards, but also that the materials and services they provide meet the specifications of the client

 
 

Consultys Quality Assurance Services

Our staff has extensive experience in regulated environments and brings this value to the table when assisting our clients with
their quality assurance-related needs.

Quality Management System - Pharma

Quality Management System

  • Quality System (QS) Development, Assessment and Optimization
  • Consolidation of Coporate Quality Management Systems
  • Policy, SOP, and Batch Record Review, Preparation, and Optimization
  • Corrective and Preventive Action (CAPA) Planning and Execution
  • Training – FDA, GMP, QSR, DQSA, USP, Data Integrity
Supplier Audits and Inspections

Supplier Audits and Inspections

  • Coordination and Execution of Supplier Audits
  • Quality Agreement Implementation and Management
  • Man-in-plant oversight
  • Quality oversight and approval of applicable GMP system
  • Supplier Audit Tracking and Monitoring

Interim QA and QP Managers - Pharma

Interim QA and QP Managers

  • Quality professionals e.g. Quality Assurance (QA) Managers, Regulatory Affairs
  • Qualified Person
  • GMP Technical Writers
  • Compliance Specialists e.g. Quality Management Systems
  • Audit Management


 

Contact our Consultys Quality Assurance Team

Please contact us to learn more about our Quality Aussurance (QA) and Auditing services.