Validation and compliance
that follows industry best practice, regulatory and quality standards

Excellis Europe deliver validation and compliance consulting services that follow industry best practices, regulatory and quality standards, and are tailored to meet our clients’ needs.

We provide the experts, processes, and tools to successfully manage a broad spectrum of validation and compliance projects.

It is important that we incorporate a risk-based methodology to help our customers achieve their compliance objectives with an end-to-end solution at a lower cost.

This includes:

  • Computer systems validation (LIMS, ELN, ERP, EDMS, MES)
  • Validation of cloud-based systems (QMS, EDMS, EPCIS system)
  • Process validation
  • Facilities qualification
  • Equipment qualification
  • Auditing and remediation
  • Data integrity assessment
  • Risk management
  • Validation and compliance training
  • Evaluate system compliance to 21 CFR Part 11, 210, 211

Serialization expertise

For the life science and pharmaceutical industry we make sure you deliver serialized products. We are a leader in traceability and understand the needs of the pharma supply chain.

We have a comprehensive and experience-based perspective on serialization and track and track solutions that we implement into our supply chain practice.

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Program and project management

At Excellis Europe, we pride ourselves on precise planning that will create accurate serialization and traceability project goals.

We minimise risks and budget-impact during a serialization program through detailed planning and a comprehensive project execution timeline.

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Regulatory requirements radar

We offer strategic and practical guidance that will make sure you are prepared for an effective manufacturer readiness programme.

Excellis Europe are the only consultancy to offer this innovative service that will enable you to understand your serialization requirements.

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