Quality Management

Validation Services

In the pharmaceutical, medical device, and other similar industries such as food, blood, tissue and clinical trials, validation is the documented act of demonstrating that a procedure, process, and activity will consistently meet the expected results. It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practice and other regulatory requirements. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

  • Cleaning Validation,

  • Process validation,

  • Analytical method validation,

  • Equipment,

  • Computer System Validation (CSV, GAMP)

Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:

  • Validation Planning

  • Design qualification (DQ)

  • Installation qualification (IQ)

  • Operational qualification (OQ)

  • Performance qualification (PQ)

  • Validation Reporting

Our Consultants have been involved in hundreds of validation projects ranging from Manufacturing, Laboratory, Clinical, Equipment and Computer Systems Validation.

Quality Management Services

  • Quality Change & Risk Management

  • Business Process & Impact Managementc

  • GCP - current Good Clinical Practicesc

  • GMP - current Good Manufacturing Practices

  • cGxPs - other Good Life Science Practices

  • IT Computerized System Validation

  • Cloud and Hybrid Cloud validation

  • Statistical Validation Services

  • Automated Testing / GxP Testing

  • Requirements Management

  • Agile Validation Services

  • Training and Knowledge Management

  • Paperless Manufacturing / eMaster Batch Records

Quality Resources

Our experienced Quality consultants can help ensure that your Quality Management System is helping your business and not hindering it. We will review your existing Quality Manual and Procedures for conformance to the regulations and standards you require, or help you to create a Quality Management System to meet your requirements. In particular using ComplianceControl Centre can help to automate your processes including:

  • Documentation

  • Change Control

  • CAPA/Deviations

  • Customer Compliants

  • Auditing

  • Training Records