One Platform for Your Entire C&Q Program
Define requirements. Assess risk. Execute IQ/OQ/PQ protocols with structured data capture. Manage deviations, collect e-signatures, and release systems — all from a single digital workspace that replaces paper binders and disconnected spreadsheets.
Supports science and risk-based C&Q aligned with the ISPE Baseline® Guide, EU GMP Annex 15, and ICH Q9.
From first requirement to system release. Every step of your C&Q program lives in one place — no handoffs between systems, no version confusion, no chasing signatures across email.
Capture user requirements, system purpose, and regulatory scope. Classify systems by product quality impact to set qualification depth.
Build structured risk assessments that connect quality attributes to process parameters and the design controls that mitigate each risk. Use AI or go manual.
Run qualification protocols with structured data capture. Record results, attach evidence, and manage deviations — all from one interface.
Verify every requirement is traced to a test result. Close deviations, collect approval signatures, lock the package, and generate True Copy PDFs.
Right-size every qualification package. Not every system needs the same depth. Classify by product quality impact and automatically adjust scope — from full IQ/OQ/PQ down to streamlined verification for support systems.
Impact Level Sets Package Scope
Direct Impact
System affects product quality or critical utility output. Full risk assessment + IQ/OQ/PQ.
Not Direct Impact
No direct product quality effect. Commissioning with engineering documentation.
| Impact | Out of the Box | Configured | Custom |
|---|---|---|---|
| Direct | 3 | 4 | 5 |
| Indirect | 2 | 3 | 3 |
| None | 1 | 1 | 2 |
Build the risk-to-test chain automatically. Structured risk connects quality attributes, process parameters, and design controls — then links forward to the test steps that verify them.
| Process Step | CQA | CPP | Design Control | Risk |
|---|---|---|---|---|
| Mixing | Homogeneity | Speed/Time | Setpoint interlock | 5 |
| Heating | Potency | Temperature | Temp alarm & control | 4 |
| Filtration | Particle count | Pressure diff. | Filter integrity test | 3 |
| CIP cycle | Cleanliness | Flow/Temp | Recipe parameters | 1 |
Run IQ, OQ, PQ, or combined qualification protocols directly in the platform. Structured data capture tables, pass/fail recording, photo and file evidence, and automatic deviation generation when a step fails.
| Step | Description |
|---|---|
| 1 | Failed test step auto-generates deviation with full documentation |
| 2 | Evaluation and assignable cause determination |
| 3 | Corrective action: define, approve, implement, test, confirm |
| 4 | Designated approver sign-off required before deviation closure |
| 5 | Re-test verification documented in the same package |
Document Workflow
ALCOA enforced at the platform level — not by procedure, but because the platform architecture makes it impossible to create non-compliant records.
Attributable
Every action linked to authenticated user. PIN-secured e-signature with name, role, timestamp.
Legible
CQValence editor with consistent formatting. True Copy PDFs with structured layout and TOC.
Contemporaneous
Time-stamped audit trail captures all entries at time of action. Status transitions logged automatically.
Original
Unique document IDs. Version control prevents unauthorized changes. System-of-record for all records.
Accurate
Unalterable audit trail. Record changes never obscure prior information. Full comment history preserved.
Trace everything, then lock it down. Before release, Valkit confirms every requirement traces to a test result, every deviation is closed, and every approval signature is collected.
Release Checklist
Requirements Verified
Trace Matrix confirms every requirement and risk item has been tested through IQ/OQ/PQ execution.
Supporting Procedures Referenced
SOPs and sampling procedures documented and linked within the validation package.
Deviations Resolved
All deviations closed with corrective actions completed, verified, and approved.
Approvals Collected
Summary Report approved with PIN-authenticated e-signatures from all designated approvers.
Package Locked
All documents approved. Package finalized. True Copy PDFs generated. System released.
Clone packages for multi-site deployment. Qualified one system? Clone the entire package for the next identical installation. Update system-specific tags and execute. Global Clone deploys across organizations for enterprise-wide standardization.
Multi-Site from One Master
WFI System — Master Qualification Package
VP + REQ + RA + CS + IQ + OQ + PQ + TMX + SR
End-to-end C&Q on one platform: define requirements, assess risk, execute IQ/OQ/PQ with structured data capture, manage deviations, and collect e-signatures. Aligned with ISPE Baseline®, EU GMP Annex 15, and ICH Q9. Traceability from quality attributes to test results; release with True Copy PDFs.
FAQ
CQV (commissioning, qualification and validation) software replaces paper binders for C&Q programs. In Valkit you define requirements, assess risk, execute IQ/OQ/PQ protocols with structured data capture, manage deviations, collect e-signatures and release systems from one workspace.
Valkit supports science and risk-based C&Q aligned with the ISPE Baseline Guide, EU GMP Annex 15 and ICH Q9.
No. Systems are classified by product quality impact (Direct, Indirect or None). High-impact systems get a full risk assessment and IQ/OQ/PQ, while support systems use reduced-scope packages.
A failed test step automatically creates a deviation with cause determination and a corrective action workflow. A designated approver must sign off before the deviation can be closed, and re-test evidence stays in the same package.
Valkit checks that every requirement traces to a test result, every deviation is closed and every approval signature is collected. Completing the package locks all documents and generates True Copy PDFs with document ID, version and signatures.