Control quality, ensure traceability, and accelerate tech transfer with a purpose-built QMS for biotechnology. Implement a robust eQMS to ensure compliance, boost efficiency, and drive innovation in biotech operations.
Control quality, ensure traceability, and accelerate tech transfer with a purpose-built QMS for biotechnology. Implement a robust eQMS to ensure compliance, boost efficiency, and drive innovation in biotech operations.
Biotech manufacturing operates in a world of scientific complexity and evolving regulatory expectations. Scaling molecules from lab to market demands rigorous documentation, tech transfer alignment, and seamless collaboration between QA, QC, and Manufacturing.
Assess and qualify critical material and component suppliers with risk-based onboarding, audits, and certificate tracking.
Proactively assess risk across raw materials, biologics processing, and cold chain handling using configurable ISO and ICH-based tools.
Ensure role-based qualification across teams with training tied to SOP versions and procedural changes-critical for fast-moving production.
Manage inspections, internal audits, and third-party reviews with structured workflows, real-time tracking, and centralized documentation.
Log deviations or bioburden events directly from the production floor. Enable fast root cause analysis and real-time resolution.
Capture and track complaints across the product lifecycle with built-in workflows for trending and regulatory reporting.
Control essential GMP documents including batch records, tech transfer files, protocols, and SOPs-all with 21 CFR Part 11 compliance.
Manage cross-functional changes to process, equipment, or materials. Align QA, RA, and Manufacturing teams with structured workflows.
Close the loop quickly by linking CAPAs to deviations, audits, and complaints. Track effectiveness checks and prevent recurrence.
Capture and investigate deviations in upstream, downstream, or fill-finish. Ensure timely resolution and impact assessments.
Biotech manufacturing requires precision, traceability, and control from cell line development to final product. Quality Forward unifies deviations, CAPAs, change control, and tech transfer documentation in a single validated platform, purpose-built for GxP, GMP, and ICH Q10 environments.
Accelerate batch release, simplify cross-site collaboration, and ensure inspection readiness with end-to-end visibility across quality, regulatory, and manufacturing teams; all powered by the trusted Now Platform.
Quickly adapt workflows for new molecules, batch processes, or regulatory shifts-no developer needed.
Easily scale from clinical-phase to global commercial operations-without burning budgets on complex IT.
Used by high-growth biotech companies and CDMOs focused on speed, compliance, and product integrity.
Get real-time data across sites, suppliers, and shifts to prevent batch delays and compliance risks.
Includes complete validation package and audit trails for regulatory inspections and internal reviews.
Secure, validated, and ready for enterprise deployment on the ServiceNow platform.
