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Assure

Maintaining compliance. Integrating continual improvement.

Maintaining control

Validation does not end with system release. We maintain compliance, safeguard data integrity and support continual improvement, ensuring control throughout the system lifecycle. That work spans audit trail review, electronic signatures, investigations, cloud validation and ongoing compliance activities.

Managing change

Regulations may stay unchanged for years; their interpretation does not. What satisfied an inspection yesterday may not satisfy one tomorrow. Systems change. Workflows evolve. Risks shift. Maintaining compliance takes continuous oversight, periodic review and processes that reflect how systems are actually used.

Risk-based decisions

Not every risk carries the same weight. Compliance should focus where it has the greatest impact: product quality, patient safety, data integrity and product availability. It is not maintained through documents alone. It rests on effective controls, sound investigations and decisions supported by evidence.

CGMP is not about staying compliant. It is about staying current.

We maintain compliance, safeguard data integrity, and support continual improvement – keeping your systems aligned with CGMP.

Data integrity
  • Implementing audit trail reviews strategies and  electronic signatures (e-signatures).
  • Ensuring data security through validated, controlled processes.
  • Designing data integrity into every system from the start. 
Analytical methodology
  • Developing and validating analytical methods in line with ICH and USP requirements. 
  • Ensuring reproducibility, reliability, and regulatory compliance of analytical results. 
Testing and SOPs
  • Functional, performance, usability, and user acceptance testing across systems. 
  • Stress testing to identify vulnerabilities and optimisation opportunities.
  • Lean, practical SOPs aligned with real-world workflows.
Documentation and investigations
  • Preparation of validation and qualification protocols, reports and CAPA documentation.
  • Management of deviations, OOS results, complaints, and investigations.
Ongoing compliance and cloud
  • Ensuring continuous alignment with evolving regulatory requirements and guidance.
  • Qualification and validation of AWS, Azure, and private cloud environments.
  • Maintaining inspection readiness and continuous operational compliance through continual change.

Talk to us

Got a GxP system to validate or a compliance gap to close?
Tell us what you’re dealing with. We'll see how we can help.

office@validview.ch
+41 71 511 22 53

DEFINE

Questioning the status quo. Anticipating needs.

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BUILD

Validating and building. Integrating GxP compliance.

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