GMP Support Functions

Training, safety, and IT are the connective tissue of a compliant facility. Zymergi's support capabilities span GMP training program management, EHS compliance in classified areas, and the computerized system administration and data integrity controls that regulators scrutinize at every inspection.

GMP induction training and ongoing refresher program delivery

Training curricula development aligned with regulatory expectations

Personnel qualification — gowning, aseptic technique, area-specific SOPs

Learning Management System (LMS) administration and training records

GMP training program design and delivery

LMS administration (ComplianceWire, Veeva Vault Training, SuccessFactors)

Adult learning principles and competency assessment

Regulatory expectations for training documentation

Safety program management in classified and production areas

Risk assessments, safety audits, and incident investigations

EHS regulatory compliance and site permit management

Emergency preparedness and response planning

OSHA, EPA, and local EHS regulatory knowledge

Hazard identification and risk assessment methodologies

Incident investigation and corrective action tracking

Safety program management in pharmaceutical environments

GMP computerized system support — MES, ERP, LIMS, historians

Data integrity controls implementation per ALCOA+ principles

User access management, audit trails, and electronic signature compliance

21 CFR Part 11 and EU Annex 11 compliance

Cybersecurity fundamentals for regulated environments

GMP system administration and change control

Data integrity gap assessments and remediation

Get in touch — let's start with a mutual confidentiality agreement.