Life Sciences & Biotech
FDA Audit Readiness Shouldn't Be a Scramble — It Should Be Your Daily Standard
XQworkflow structures your cGMP procedures, batch record reviews, and training requirements into daily workflows your team executes and your QA leadership can see in real time.
Always Inspection-Ready
- cGMP workflow compliance tracked daily, not quarterly
- Batch records and deviation logs audit-ready at any time
- Training completion verified before staff execute procedures
FDA 21 CFR Part 11 cGMP ICH Q10 ISO 13485 EMA GLP SOX
An FDA 483 observation shouldn't be the first sign of a compliance gap
Life sciences organizations face some of the most rigorous regulatory scrutiny in any industry. The risk isn't just financial — it's product safety, patient outcomes, and your license to operate.
Warning letters from SOP non-compliance
FDA investigators consistently cite failure to follow written procedures as a primary observation. Without daily visibility, leaders only learn of gaps after they're documented.
CAPA systems that don't close findings
Open corrective actions that linger for months — or get "closed" without evidence of effectiveness — are a recurring theme in FDA warning letters and import alerts.
Training records that lag behind procedure changes
When an SOP is updated, verifying that every affected employee has read and acknowledged the change is often tracked in spreadsheets — creating audit exposure.
Built for Life Sciences
The compliance infrastructure your QA team needs
From clinical to commercial stage, XQworkflow gives quality and operations teams a structured system for executing and evidencing GMP compliance — every day.
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SOP-Driven Digital Workflows
Convert your written procedures into structured, executable workflows with mandatory sign-off steps, conditional branching, and electronic signatures for 21 CFR Part 11 alignment.
Deviation & CAPA Tracking
Log deviations, investigations, and corrective actions directly in the workflow. Every action is timestamped, assigned, and tracked to verified closure.
Training Verification Built In
Require staff to acknowledge procedure updates before they can execute affected workflows. Training completion is documented automatically — no separate tracking spreadsheet.
Batch Record & Audit Trail Support
Every workflow execution creates a complete, immutable audit trail with timestamps, user identities, and version history — ready when inspectors ask.
Simple to Start
From SOP to compliant execution in days
01
Structure your procedures
Import your existing SOPs and batch record steps into customizable workflow templates. Add required sign-offs, attachments, and conditional logic to match your actual processes.
02
Assign, schedule, and execute
Push workflows to QA staff, operators, and lab technicians. Set recurring schedules for periodic reviews and get real-time completion status across your entire organization.
03
Demonstrate compliance at any time
QA leadership sees live compliance status across every site and function. When an inspector arrives, your documentation is complete, timestamped, and audit-ready.
Covers the requirements FDA, EMA, and ISO auditors assess
XQworkflow is structured around the quality management requirements life sciences organizations must demonstrate — from procedure execution to CAPA evidence.
FDA 21 CFR Part 11 21 CFR Part 211 cGMP ICH Q10 ISO 13485 ISO 9001 EMA GMP GLP GCP MDSAP
What compliance leaders are saying
"Another thing I like is the escalation process. So we have the natural escalation of things from the front line user to someone who can take action. And then it tracks that accountability."
"Honestly, it's given our compliance a healthier culture."
"No one has to guess what's expected of them anymore."
"All staff members have what they need to be successful now."
"We've taken a cumbersome process and made it easy."
"It's not hard to tell how compliant we are anymore. I can do it from my desk now."
"I've been really impressed by having a scoreboard of who needs to do what today."
"XQworkflow is far better than the alternatives."
See it in action — book a personalized demo
We'll walk you through how XQworkflow works for your industry, your workflows, and your team. No pressure, no obligation.