From GMP compliance risks identified from an internal, external or Pharmalliance audit we can assist in developing, initiating and managing your remediation project, including:

• Project Management, including: scope, cost schedule and resource management

• Client Representation - we often sit in the interface between client sites and engineering design firms to ensure proposed improvements are in line with industry best practices and regulatory compliance requirements

• Engineering Support - we provide supplementary staff for project deliverables including: URS, FRS, Technical Specifications, Datasheets

• Design Reviews, including: 30%, 60% and 90% reviews, GMP and HSE and reviews

• Risk Assessments, including: Failure Mode and Effect Analysis (FMEA) and HAZOP support

• Project Documentation, including: User Requirement Specifications (URS), Technical Specifications, Datasheets, Plans, Protocols and Reports

• Equipment Lifecycle, including: equipment and sensor risk assessments, 

• Validation Support, including: Commissioning, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocol generation and execution

 

We work in collaboration with your onsite team and design partners to support your remediation activities. Quality, compliance and project delivery are at the core of what we do. Get in contact today to see how we can assist with your continuous improvement initiatives.