Batch Record Review

Batch Record Review & Certification Services for Regulated Manufacturers

Accelerate batch release, reduce QA backlog, and avoid costly documentation errors. Altabrisa Group provides expert Batch Record Review and Third-Party Certification services to help life sciences companies maintain GMP compliance and inspection readiness.

Why Batch Record Review Is Critical to Compliance?

Incomplete or inconsistent batch records can result in FDA 483s, rejected lots, or delayed product release. Our expert reviewers ensure each production record is audit-ready, complete, and compliant with GMP, ICH, and FDA expectations.

How Altabrisa Group Supports Your Batch Review Process?

Step 1:

Structured Review Based on GMP

Step 2:

Trending & Error Identification

Step 3:

QA-Driven Feedback Loop

Third-Party Batch Record Review & Certification

We provide independent review and certification of GMP batch records for companies that need external QA support. Our certified consultants help you speed up lot release, reduce backlog, and provide objective documentation for internal or sponsor audit readiness.

Why Clients Choose Altabrisa Group?

Reduces QA workload
Accelerates batch release
Improves consistency
Avoids compliance issues
Supports remote or onsite reviews

Trusted by Regulated Life Sciences Organizations

We work across the full spectrum of GMP-regulated manufacturing and testing environments.

Biotech laboratory with scientists analyzing cell cultures and gene sequencing data

Vaccine production line with vial inspection in sterile environment

Analytical lab with assay validation, data review, and instrument qualification

Your Strategic Partner in Batch Record Compliance

We embed with your team or operate independently to bring your records up to regulatory standards—without slowing operations.

Frequently Asked Questions

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Let’s Strengthen Your Batch Record Review Process

From routine review to third-party certification, we help you clear QA backlogs, prevent inspection issues, and deliver compliance-driven documentation—batch by batch.

Altabrisa Group Limited, LLC
1309 Coffeen Ave, Suite 832, Sheridan, WY 82801
📞 Raleigh Office: 919-297-2800
📧 Email: info@altabrisagroup.com

our approach

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We've been in your shoes and understand the challenges you face.

Our team of seasoned subject matter experts, each with over 20 years of experience, provide tailored solutions for organizations of all sizes. At the core of our services is our proprietary AdaptiStrat® System, a cutting-edge approach designed to deliver lasting results and drive quality. By combining our consultants’ wealth of expertise with this innovative system, we are uniquely positioned to help clients achieve their goals and create a solid foundation for compliance and regulatory success.