Our Expertise
Secure your data, your systems and your GxP compliance
Our engagements combine regulatory expertise, an understanding of business processes and knowledge of operational realities.
Our Expertise
Our engagements combine regulatory expertise, an understanding of business processes and knowledge of operational realities.
Data Integrity, computerized system validation and inspection readiness cannot be addressed in isolation.
Our cross-functional approach helps identify the real causes of deviations and build solutions tailored to their level of risk.
Reliable, intact and available
Validated and under control
Effective and compliant
Clear responsibilities and the right skills
Complementary expertise to address your challenges throughout the lifecycle of your data and systems.
Ensuring reliable data throughout its lifecycle
We help you assess and strengthen control over your GxP data, whether paper-based, electronic or from hybrid processes.
Validating systems based on their use and risk
Validate your systems according to their intended use, the criticality of the data they generate and the associated risks. The goal is to produce the necessary evidence without multiplying documents or tests that add no real value.
Turning deviations into lasting, demonstrable corrective actions.
We help you prioritise findings, define a realistic strategy and support the implementation of corrective and preventive actions.
Preparing your systems, your evidence and your teams for what authorities expect.
We identify vulnerable points and help you gather the evidence needed to present a clear, well-controlled system.
Making Data Integrity a daily practice
We design training tailored to each audience's responsibilities, work situations and level of maturity. Production operators | Laboratory staff | Quality Assurance | IT teams | System owners and Process owners
Our expertise can be mobilised:
Addressing a specific need: risk analysis, documentation review, audit preparation, system qualification or team training.
Addressing a specific need: risk analysis, documentation review, audit preparation, system qualification or team training.
Structuring and steering a Data Integrity or CSV approach involving several systems, processes, sites or functions.
Engagements can be combined depending on your starting point. An initial conversation helps scope the work.
Get in touch