DoQStack

DoQStack (eCSV) is an electronic Computer System Validation (eCSV) solution developed by Sarjen Systems, designed for life sciences organisations that need to meet GxP and business compliance requirements. It automates and streamlines the validation process, reducing manual effort, minimising errors, and accelerating time to compliance within a regulated environment.

The platform is pre-validated and built around predefined GAMP5 document structures, enabling teams to adopt it quickly. Sarjen Systems states that DoQStack can go live within two weeks of implementation, allowing organisations to begin compliant validation workflows without extended setup periods.

Key Features

• Smart capture for screenshots: Automates screenshot capturing during test script validation, reducing the need for manual documentation and lowering the risk of errors.
• Predefined GAMP5 document templates: Provides ready-to-use document structures aligned with GAMP5 guidelines, supporting regulatory compliance from the outset.
• Seamless automation of CSV: Automates core Computer System Validation workflows to reduce complexity and manual intervention throughout the validation lifecycle.
• Intelligent project monitoring: Tracks validation projects to support oversight and progress management across the team.
• eSignature integration: Supports electronic signatures as part of the validation and compliance workflow.
• Rapid deployment: Designed to go live in two weeks, enabling faster time to compliance.

Compliance and Regulatory Alignment

• Built to support GxP compliance requirements applicable to life sciences organisations.
• Incorporates predefined GAMP5 document structures to align with industry-standard validation frameworks.
• Designed to help teams meet regulatory requirements without extensive manual configuration.

Broader Sarjen Systems Portfolio

• DoQStack (eCSV) sits within Sarjen Systems' Regulatory and Compliance solutions, alongside eCTD Dossier Publishing and a RIMS solution.
• Sarjen Systems also offers solutions across Clinical Research (early-phase and late-phase trials, bioanalytical LIMS), Pharmacovigilance (safety database), Quality Management, Pharma MES for manufacturing, Supply Chain (sales and distribution), and CRM (customer support and relations).
• Additional services include Regulatory Services, Power BI, SAP, AI and Automation, and Custom Project Services.

DoQStack is offered by Sarjen Systems as part of a broader suite of life sciences software solutions. Organisations interested in the platform can request a demo directly through Sarjen Systems.