Enabling the Digital Laboratory of the Future

We support every step from configuration to compliance, ensuring your systems perform where it matters most.

Equipment Setup & Validation

We manage the complete setup, qualification, and documentation process for laboratory equipment — ensuring compliance with GxP, 21 CFR Part 11, Annex 11, and your internal quality standards.

What We Offer:

  • Coordinate installation and vendor qualification for new lab instruments
  • Perform or oversee IQ/OQ/PQ protocol execution
  • Develop and manage URS, traceability matrices, and validation documentation
  • Align equipment usage with digital tracking systems such as ELN and LIMS
  • Remediate legacy equipment or incomplete documentation from past setups.

Spotlight Project:

Validated a GAMP 5 Category 5 script-based application used to support data analysis in Phase II and III clinical trials. Delivered a full validation package — including risk assessments, traceability matrix, and IQ/OQ protocols — aligned with FDA, EMA and sponsor requirements.

Digital Solution Management

We help laboratories implement and optimize digital platforms like ELN and LIMS, aligning configurations with scientific workflows, data integrity requirements, and compliance expectations.

What We Offer:

  • Configure ELN, LIMS, and inventory systems
  • Design schemas and workflows tailored to your lab processes
  • Map user roles, permissions, and data access policies
  • Ensure system alignment with ALCOA+ and 21 CFR Part 11 requirements
  • Collaborate with IT and QA to streamline onboarding and validation
  • Develop supporting documentation (URS, SOPs, training guides).

Spotlight Project:

Reconfigured the Benchling Inventory module for a biotech R&D team to improve sample traceability and user compliance. Developed schema, documentation, and training materials to support adoption across departments.

Laboratory Digital Transformation

We support labs through end-to-end digital transformation initiatives — modernizing processes, integrating systems, and building a foundation that supports both scientific innovation and regulatory compliance.

What We Offer:

  • Assess current digital maturity and identify opportunities for improvement
  • Develop digital transformation roadmaps tailored to lab type, size, and needs
  • Align transformation goals with GxP and data integrity expectations
  • Integrate laboratory systems (ELN, LIMS, QMS, equipment) into a cohesive ecosystem
  • Deliver targeted training on regulatory expectations, data integrity principles, and system use
  • Design change management strategies that include training, SOPs, and governance.

Spotlight Project:

Led a digital transformation initiative to modernize R&D workflows across multiple laboratory systems. Evaluated and aligned platforms such as LIMS, ELN, and biobanking software with business and regulatory goals. Introduced data integrity and governance improvements that enhanced system interoperability, traceability, and overall compliance posture.