Services

Validation (GxP/GAMP5)

Compliance and quality is important to all processes and system implementations in Clinical Development. The client’s IT QA department is responsible for validation of systems. HERAX provides a series of validation services to support daily operations as well as in relation to specific projects. All HERAX validation services are based on GAMP5.


Validation Planning
Risk Analysis
GAMP5 Advisory
Test Development
Validation Implementation
Qualification
Validation Planning

Planning of validation efforts in relation to system implementation. Creation of both Validation Master Plans and Validation plans is provided as a standard offer by HERAX.

Risk Analysis

In order to ensure an effective validation with the right level of quality, a Risk analysis has to be performed to gauge the different areas being impacted, in terms of both functionality and processes. Getting the Risk analysis right is critical to a good validation plan. HERAX combines the standard GAMP5 approach with an extended questionnaire to identify risk areas.

GAMP5 Advisory

HERAX provides GAMP5 analysis and QMS evaluations for clients seeking to implement GAMP5 as a standard in their system validation. This includes assistance with updating the QMS system to correctly reflect GAMP5 with standard templates, instructions, samples and training.

Test Development

Development of PQ (Performance Qualification), OQ (Operational Qualification) and IQ (Installation Qualification) to test the URS, Functional Specifications, and Design Specifications. Associated Use Cases are a standard offering, provided to almost all project where HERAX assists with implementations.

Validation Implementation

Entrusting the entire validation effort to HERAX is a possibility used by more and more clients. The client and HERAX agree on the quality level of the validation based on a risk analysis and a list of deliverables. Subsequently, HERAX handles everything and the client only needs to approve of the deliverables.

Qualification

HERAX provides qualification services for non-GxP system implementations and for GxP implementations where areas can be defined as low-risk based on a risk assessment.