Process Capability (Cp/Cpk)
Capability indices calculated per critical parameter and product.
Process Capability calculates Cp, Cpk, Pp and Ppk for every critical process parameter against approved specification limits, flagging parameters as capable, marginal or at risk directly within the annual review.
What Process Capability (Cp/Cpk) delivers
A controlled path from start to closure
- 1Collect Parameter Data
- 2Apply Limits
- 3Calculate Indices
- 4Classify Status
- 5Trend
- 6Report
Why teams move to Process Capability (Cp/Cpk)
Replace offline capability spreadsheets with validated calculations
Flag marginal or at-risk parameters before they become deviations
Support specification review with objective capability evidence
Compare process capability consistently across sites and lines
Give reviewers a statistically defensible process performance view
Built for regulated operations
21 CFR Part 11
Electronic records and electronic signature controls — unique user identity, secure e-signatures and computer-generated audit trails on every record.
EU GMP Annex 11
Computerised system controls including access management, change control, data integrity and periodic review of the system.
GAMP 5
Risk-based validation approach, with pre-executed IQ/OQ documentation supplied with every release.
ALCOA++
Records that are attributable, legible, contemporaneous, original and accurate — enforced at record level.
OPS IQ is designed to support these regulatory expectations. Compliance is achieved together with your own validated implementation, procedures and controls.
Connected to your enterprise systems
ERP / SAP
Master data, materials and batch context exchanged over open REST and event APIs.
MES
Shopfloor execution events and equipment context linked to quality records.
LIMS
Laboratory results and specification data connected to quality decisions.
Identity Providers
Enterprise SSO and role-based access through your existing identity provider.
Enterprise APIs
Open REST and event APIs for custom and legacy systems.