Built for Compliance

Validation Services for Growth Direct®

From pre-installation through performance qualification, our validation experts ensure Growth Direct® is implemented in full alignment with global regulatory expectations. With decades of experience in rapid microbial method (RMM) validation, we help pharmaceutical manufacturers bring Growth Direct® online efficiently and compliantly.

FULL-SERVICE VALIDATION SUPPORT

Validation Expertise You Can Trust

Our validation team partners with pharmaceutical manufacturers to deliver a smooth, compliant onboarding of the Growth Direct® System. With decades of combined experience in rapid microbial methods (RMM), we help you qualify the system efficiently—typically within four months. Service include:

Installation Qualification (IQ)

Verifies that the Growth Direct® System is installed correctly and according to specifications.

Operational Qualification (OQ)

Confirms that system functions perform as intended under defined conditions.

Performance Qualification (PQ)

Demonstrates consistent, reliable performance in your specific environment.

Method Qualification / Method Suitability (MQ/MS)

Ensures the method is appropriate for your product and testing requirements.

21 CFR Part 11 Assessment

Supports compliance with electronic records and electronic signature regulations.

Growth Direct system used for rapid sterility testing in GMP facility

Data integrity and audit trail support

Provides traceability, secure access control, and complete audit trails for regulatory review.

CONNECTIVITY & DATA FLOW

Digitize and Connect with Confidence

Our universal communication platform enables bi-directional integration between Growth Direct® and your laboratory information management system (LIMS).

Whether you use environmental monitoring trending software or in-process control databases, our system produces standardized .csv exports compatible with most networked environments.

QC microbiology automation platform improving data integrity and reducing manual errors

IT & DATA INTEGRITY

Validated, Secure Network Integration

We validate the Growth Direct® Remote Monitoring System (RMS) and conduct third-party security audits on the RMS server. This ensures data protection, access control, and secure networking in compliance with IT and GMP expectations.

ONBOARDING MADE SIMPLE

Training Programs Tailored to Your Team

We offer simplified, hands-on training to help microbiologists quickly adopt Growth Direct® as a Rapid Microbial Method. Programs are tailored to your application (e.g., EM, sterility, bioburden) and may include feasibility support and protocol development.

BUILT TO MEET GLOBAL GUIDELINES

Validated According to Regulatory Standards

Growth Direct® is validated in alignment with key regulatory frameworks:

USP <1223> and EP 5.1.6 for automated colony enumeration
PDA Technical Report 33 (TR33) for automated methods
Precision and accuracy verified through spike and recovery testing
Media performance equivalence to standard agar plates.

REAL-WORLD VALIDATION SUCCESS

See How Manufacturers Use Growth Direct®

Our proven validation strategy has helped top pharma and biotech companies automate QC microbiology while meeting regulatory expectations. Explore how others have successfully implemented Growth Direct®.