Nexgensis TechnologiesNexgensisTechnologies

Equipment Clearance

Equipment status, cleaning validity and usage logged per step.

Equipment Clearance confirms equipment identity, cleaning status and calibration validity before it can be used on a batch step, and logs usage automatically into the equipment history.

What Equipment Clearance delivers

Equipment identity verification before use
Cleaning status and validity period checks
Calibration due-date validation at point of use
Automatic usage logging per batch and step
Cross-contamination prevention through product-line locking
Equipment downtime and maintenance flag visibility
Cleaning record linkage to the batch it clears for

A controlled path from start to closure

  1. 1Scan Equipment
  2. 2Verify Cleaning Status
  3. 3Verify Calibration
  4. 4Clear for Use
  5. 5Log Usage
  6. 6Release

Why teams move to Equipment Clearance

Prevent use of uncleaned or out-of-calibration equipment

Cut cross-contamination risk with product-line locking

Automate equipment usage logging without paper logbooks

Give maintenance teams visibility into equipment flags

Link every batch to a verified equipment history

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.

Works with the rest of OPS IQ

Want to see how Equipment Clearance works for your organization?