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K2C Product

One connected platform. A modular approach.

Explore platform architecture, governance, security and the flexible adoption model.

Explore the Product →
Platform Overview →Modular governance and quality management for Life Sciences.Modular Architecture →Start with a priority process and extend over time.Security & Auditability →Access, controlled workflows, audit trails and records.Plan Your Implementation →Talk through an initial scope and rollout priorities.
K2C Solutions

Quality capabilities around your priorities.

Six complementary capability families, connected by shared governance.

Explore All Solutions →
Quality Management →SOPs, training, changes, issues, CAPA and quality plans.Audit & Supplier Quality →Qualifications, supplier audits, process audits and findings.Clinical Quality & GCP →Clinical studies, audits, TMF and IIS.Pharmacovigilance & Safety →PSMF, PV agreements and SAE/SUSAR processes.Laboratory & Technical Operations →Notebooks, analytical methods and technical reports.Medical & Regulatory Affairs →Medical inquiries and marketing materials.
About K2C

Quality governance. Lasting partnership.

Learn about K2C and connect with our team to discuss your quality priorities.

Discover K2C →
About K2C →Our approach to modular governance, implementation and customer enablement.Contact →Book a Discovery Session and discuss your quality priorities.
ProductPlatform OverviewModular ArchitectureSecurity & Auditability
SolutionsAll SolutionsQuality ManagementAudit & Supplier QualityClinical Quality & GCPPharmacovigilance & SafetyLaboratory & Technical OperationsMedical & Regulatory Affairs
IndustriesServicesWhy K2C
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VALIDATION SUPPORT BUILT INTO THE DELIVERY MODEL

Validation & Compliance

For organisations using computerised systems in GxP-regulated processes, validation and qualification should be planned around intended use, applicable requirements and risk. This can be one of the most demanding aspects of a QMS implementation.

Start with a documented core platform and qualify the configured implementation around intended use, risk and lifecycle change.
K2C

Validation & Compliance

01

Pre-validated platform architecture

Use a documented core platform to support a configured implementation.

02

Risk-based strategy (GAMP 5)

Focus on intended use and areas of greatest risk.

03

Platform documentation package

Supplier documentation describing standard controls and functionality.

04

Configuration-specific qualification templates

Tailor protocols to workflows, integration and customisation.

05

Execution guidance and evidence

Support execution, deviations and traceable documentation.

06

Change control and validated state

Assess changes through the system lifecycle.

K2C

Audit readiness

Document validation decisions, rationale and evidence so the implementation remains explainable during internal review and regulatory inspection.

01

Intended use

Define scope, responsibilities and acceptance criteria.

02

Validated state

Assess the impact of changes, upgrades and configuration updates.

K2C

Ready to qualify your implementation with confidence?

Tell us which quality processes create the most friction today.

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