Employee Qualification
Qualification status maintained per employee, role and activity.
Employee Qualification tracks the specific activities each individual is authorised to perform, combining training completion, assessment results and practical evaluation into a status that controls what they can be assigned on the floor or in the lab.
What Employee Qualification delivers
A controlled path from start to closure
- 1Train
- 2Evaluate
- 3Qualify
- 4Monitor
- 5Requalify
Why teams move to Employee Qualification
Ensure only qualified staff perform GMP-critical activities
Catch expiring qualifications before they lapse
Provide auditable evidence linking training to demonstrated skill
Reduce disputes over who was authorised to perform a task
Simplify shift handover by showing qualification at a glance
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.