Validation

In life science, all computerized systems must be validated based on a risk-based approach in compliance with GAMP5, CFR part 11 and ISO13485, and more. The risk-based approach focuses on establishing the criticality of output from the system and the potential risks related to this output. This leads to necessary controls and mitigating actions that need to
be implemented in solution design and/or the validation strategy.

Use Cases / User Stories and User Requirement Specifications, supporting new SOPs, Configuration specifications, all
aligned to save time and effort when implementing and maintaining the system.

We can help throughout establishing a validation environment, create test plans and test cases and final acceptance
testing and go-live.

HERAX will drive the validation of the new solution:

• Identifying the specifications
• GAMP5 classification validation requirements
• Prepare risk analysis/assessments
• Establish validation strategy
• Prepare validation protocol/plans (IQ/OQ/PQ)
• Prepare, and maintain traceability matrix
• Execute the validation/test plan, resolve deviations, retest as needed
• Gather documentation and ensure approval of completed validation.

Additional support

• Vendor audits – IT vendor audits, evaluation of QMS quality and adherence, SDLC evaluations and service provider audits (both IT and CROs)

Additionally, HERAX provides validation and qualification services for ongoing system upgrades, new configurations,
periodic reviews, and AI/ML solutions.

Compliance

Life science companies must ensure compliance with constantly changing external regulatory requirements and internal policies.

Key areas:

• GxP/GDPR compliance and GAP assessments
• Vendor Audits
• GAMP5 validation compliance
• SOP compliance assessment
• SDLC documentation

HERAX offers a full range of compliance advisory services, revision, and development of new SOPs to compliance evaluation in implementation projects.

Specifically, for GxP/GDPR compliance, in an initial phase we will conduct an assessment to determine the criticality of the solution followed by an as-is analysis identifying existing documentation. Next is a gap analysis that will list all documentation needed for the computerized system to be complying and data subject to GDPR.

Vendor Audits

For vendor audits we can offer audit planning, audit conduct and audit closure and will deliver an audit report. We help you with IT vendor audits, evaluation of QMS quality and adherence, SDLC evaluations and service provider audits (both IT and CROs).