Batch record review software with built-in AI to automate compliance and reduce release delays

Q: What is batch record review?

Batch record review is the formal process of verifying and approving all manufacturing documentation before a product batch is released.

Q: How does Process Street support batch record reviews?

We automate review workflows, capture sign-offs, and maintain traceable records to ensure data integrity and regulatory compliance.

Q: Can we route reviews across teams?

Yes. You can assign tasks to QA, QC, production, or any stakeholder with automated handoffs and approvals.

Q: How does the system handle deviations and corrections?

You can launch deviation or CAPA workflows directly from flagged records and track resolution to closure.

Q: Is Process Street compliant with FDA and ISO requirements?

Yes. Our platform supports 21 CFR Part 11, ISO 13485, and ISO 9001 documentation standards and audit expectations.

Q: How fast can we launch batch review workflows?

Most teams are live in under a week with templates, guided onboarding, and no-code setup.

Standardize manufacturing record reviews, enforce data integrity, and stay audit-ready, powered by Cora, your AI compliance agent.

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Batch record review software with built-in AI to automate compliance and reduce release delays

Trusted by more than 3000 companies

What's your biggest batch record review challenge?

Standardize batch record workflows with structured templates and automated data capture.

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Batch record review is critical to product release, and a frequent source of compliance risk.

Life sciences, pharmaceuticals, and medical device teams need error-free, traceable reviews to stay compliant with FDA and ISO requirements. Process Street's batch record review software automates review workflows, tracks corrections, and ensures records are complete before approval. Eliminate backlogs, reduce errors, and protect product quality.

Centralize and control all batch records

Store production records, deviation logs, QC checks, and approvals in one system. Use version control and role-based access to maintain data integrity.

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Centralize and control all batch records

Turn review procedures into workflows

Automate batch record review, approval routing, and corrections. Assign reviewers, enforce timelines, and flag incomplete or missing information.

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Reduce errors and accelerate batch release

Catch issues earlier with automated checks and real-time alerts. Link CAPA workflows to records with discrepancies.

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Reduce errors and accelerate batch release

Ensure compliance with built-in sign-offs and logs

Enforce multi-step approvals, track reviewer comments, and maintain a complete time-stamped audit trail.

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Meet Cora:
Your AI compliance partner

Cora isn't just a task tracker. She's your digital batch review partner. Integrated into Process Street, Cora ensures every batch record is complete, accurate, and review-ready.

Drafts and aligns review procedures Build review workflows aligned with SOPs and regulatory expectations
Transforms review into execution Automate task assignments, sign-offs, and documentation checks
Scans for gaps Detect missing entries, unverified results, or incomplete records
Prepares for audits Auto-generate batch histories, approvals, and CAPA records on demand

With Cora, your batch review process
becomes audit-ready by default.

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Streamline batch approvals across teams

Route reviews across QA, production, and compliance with shared task visibility. Prevent bottlenecks with automated reminders and escalations.

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Strengthen data integrity and error resolution

Validate entries against SOPs, flag discrepancies, and launch CAPAs when needed. Maintain traceability from issue to resolution.

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Manage deviations and change control

Trigger deviation workflows directly from batch record entries. Log change requests and route approvals in real time.

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Gain oversight with real-time dashboards

Track review status, open issues, turnaround times, and overdue reviews. Monitor performance and drive continuous improvement.

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Process Street powers batch review for FDA-regulated and ISO-certified teams worldwide:

Batch record review and approval

Automate batch review workflows with task assignments, sign-offs, and compliance tracking.

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Deviation and CAPA management

Capture issues and route them through CAPA workflows tied directly to batch records.

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Document and data integrity

Control batch documentation access, versioning, and approvals in a compliant system.

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Cross-functional review coordination

Connect QA, manufacturing, QC, and compliance in one workflow for record approval.

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Training and SOP enforcement

Tie batch execution and review to training records and SOP acknowledgment.

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Audit preparation and inspection readiness

Generate time-stamped audit trails for every review, correction, and approval.

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Frequently asked questions

Can't find the answer you need? Contact our support team.

What is batch record review?

How does Process Street support batch record reviews?

Can we route reviews across teams?

How does the system handle deviations and corrections?

Is Process Street compliant with FDA and ISO requirements?

How fast can we launch batch review workflows?

Trusted by 3000+ companies

From global pharmaceutical firms to fast-scaling biotech,
Process Street keeps batch record reviews on track and audit-ready.

Data protection & security

ISO27001 compliance

Process Street is ISO 27001 certified, confirming compliance with global standards and a strong commitment to protecting customer data through audited, continuously monitored security controls.

Data protection & security

SOC 2 Type II compliance

Process Street has passed a SOC 2 Type II audit, confirming that it meets various criteria for safeguarding customer data. An independent external auditor has verified the effectiveness of the controls implemented by Process Street.

Healthcare information privacy

HIPAA compliance

HIPAA, a federal law, safeguards patient health information. Process Street's robust security measures include the option for a Business Associate Agreement upon request, ensuring HIPAA compliance.

Data protection & security

AWS CIS compliance

The CIS AWS Foundations Benchmark provides security best practices for AWS environments. Process Street's compliance ensures a secure cloud infrastructure by following established guidelines for configuration and monitoring.

EU Data protection & privacy

GDPR compliance

The General Data Protection Regulation (GDPR) is an EU law designed to protect the privacy of individuals and businesses in the EU economic area. It establishes rules for how personal data is collected and handled. Read our GDPR statement

Data protection & privacy

CCPA compliance

The California Consumer Privacy Act (CCPA) gives California residents more control over their personal data, including rights to access, delete, and opt out of data sales. Process Street ensures compliance through transparent practices.

Security & privacy

Artificial intelligence

Your data is never used to train AI models. Any data read or created by a workflow is exclusive to that particular workflow instance and cannot be accessed otherwise, even from within the same organization.

Data sovereignty & infrastructure

Data residency & private cloud

Choose where your data is stored with support for US, UK, Canada, EU, and UAE regions. Customers can also opt for private cloud deployment in their own VPC for maximum control and security.

Backed by happy clients

With Process Street we've been able to bring documentation to life… allowing us to adapt processes quickly, improve governance and achieve consistent results