Comprehensive Supporting Services

After-Sales Service | 3Q Validation Service

The Archimed Time-Resolved Quantitative PCR System is Rocgene’s first real-time fluorescence quantitative PCR system meticulously developed to meet the practical needs of mid-to-high-end users. Supported by novel Fresnel lens-based optical signal acquisition, patented time-resolved signal separation, and unique thermal control technologies, the Archimed series achieves outstanding performance in detection sensitivity, multi-color crosstalk, temperature uniformity, and accuracy.

To meet the demands of customers in pharmaceuticals, healthcare, food safety testing, and other fields, Rocgene provides on-site performance verification services, namely 3Q Validation. This service ensures the compliance, reliability, and stability of instruments, systems, or processes, serving as a quality cornerstone for highly regulated industries such as pharmaceuticals and medical devices.

What is

3Q Validation Service?

3Q Validation is a key concept in Quality Assurance (QA) and GMP compliance, widely applied in pharmaceuticals, medical devices, laboratory equipment, and manufacturing to ensure equipment, systems, or processes meet required standards.

Components of 3Q Validation:

3Q Validation consists of three phases, typically performed sequentially:

Application Scenarios: Drug R&D (preclinical / clinical), quality control for cell therapy, GMP production environment monitoring.

Target Customers: Pharmaceutical companies (requiring NMPA/FDA submission compliance); CROs (improving data credibility and customer trust); third-party testing labs (enhancing certification and competitiveness).

When discussing 3Q services, we must highlight Rocgene’s meticulously designed Audit Trail Management System, which also targets pharmaceutical companies, CROs, cell therapy firms, and other industry clients.

What is

Audit Trail Management System?

An Audit Trail Management System is a technical solution for recording, storing, and analyzing all activities within a system or organization, primarily used to meet compliance requirements, security monitoring, and operational transparency. The ArchiSign Data Audit Trail Management System is a cost-effective tool that standardizes experiments and ensures full traceability of data.

With the advent of the “Electronic Record Era” in pharmaceutical data management, data security, audit trails, and electronic signatures have become critical for pharmaceutical companies, CROs, and cell therapy enterprises during R&D.

The ArchiSign Data Audit Trail Management System uses a client-server architecture and consists of two parts:

ArchiSign Core System: Runs in the background, storing settings, user accounts, audit records, and electronic signatures.

Analysis Software: Integrated into Archimed Analyzer, allowing users to perform electronic signatures, data logging, and report export.

Case Study

To implement the Drug Administration Law and Vaccine Administration Law, the National Medical Products Administration (NMPA) issued the Requirements for Drug Records and Data Management (for Trial Implementation), effective December 1, 2020. This regulation legally affirms electronic records across all drug R&D, production, distribution, and use stages, marking the official arrival of the “Electronic Record Era” in China’s pharmaceutical data management.

Among many pharmaceutical, CRO, and cell therapy clients, a Beijing-based pharmaceutical company needed data security, audit trails, and electronic signatures for R&D. Previously, such systems were monopolized by imported vendors, requiring expensive equipment and software. Rocgene’s ArchiSign + 3Q Validation package provided a more cost-effective alternative.

As the first domestically developed data security and audit trail software for quantitative PCR, ArchiSign significantly improves supervision and review efficiency, reduces audit costs, and supports the healthy development of pharmaceutical R&D.

Order Information

Rocgene’s 3Q Service ensures instrument accuracy, stability, and compliance, meeting strict requirements in molecular diagnostics, genetic testing, and scientific research. 3Q Validation fully satisfies GMP, ISO 13485, and FDA 21 CFR Part 11 regulations in pharmaceutical and IVD industries.

Rocgene’s ArchiSign + 3Q Validation solution fills the domestic gap in qPCR data integrity tools, helping customers reduce costs and replace imported software. For technical support or detailed 3Q service plans, contact the Rocgene professional team for customized solutions.

After-Sales Hotline: 010-86229225 ext. 2

Technical Support: 400-860-5168 ext. 4483
Official Website: http://www.rocgene.com