cGLP & cGMP Solutions That Actually Ship

Expert data review, AI-supported automation, and custom LIMS/ELN solutions.

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Core Services

Solutions designed for pharmaceutical laboratories that need results

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cGLP/cGMP Data Review

Expert QC review with over 10 years of experience in bioanalytical laboratories

  • Raw data and report review
  • CAPA recommendations
  • Pre-inspection checks
POPULAR
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AI-Supported Automation

Transform paper-based QC processes with cutting-edge automation

  • AI-assisted QC checks
  • Workflow automation design
  • Data package assembly
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LIMS & ELN Solutions

Custom laboratory information management tailored to your workflow

  • Requirements capture
  • Configuration and validation
  • Migration and optimization

cGLP/cGMP Data Review Services

What's Included

  • Comprehensive raw data review
  • Study report verification
  • Audit trail analysis
  • Bioanalytical method assessment
  • Data review for stability, in-process, finished product, raw materials testing
  • PK/ADA/nAb data evaluation for nonclinical and clinical trials
  • Regulatory compliance check

Pricing

Monthly RetainerStarting at $2,500/month

Ongoing review support with priority access

Per-Study Review$1,500 - $5,000

Based on study complexity and data volume

Ideal For

  • CROs/CMOs preparing for audits
  • Biotech companies without dedicated QA/QC
  • Labs needing independent verification
  • Pre-submission data review
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AI-Supported Automation Services

What's Included

  • Handwritten notebook digitization
  • AI-assisted compliance checks
  • Automated workflow design
  • Custom script development
  • 21 CFR Part 11 compliance
  • Integration with existing systems

Pilot Program

LIMITED SPOTSAutomation Pilot$5,000 - $15,000

4-6 week proof of concept with your actual data

  • Process analysis
  • Prototype development
  • ROI calculation
  • Implementation roadmap

Expected Results

  • 50% reduction in review time
  • Zero transcription errors
  • Complete audit trails
  • Instant compliance reporting
Join Pilot Program

LIMS & ELN Solutions

What's Included

  • Requirements gathering workshops
  • Vendor selection guidance
  • Custom configuration
  • System validation (IQ/OQ/PQ)
  • Data migration strategy
  • User training programs

Pricing

Configuration Project$15,000 - $50,000

Full system setup and validation

Consulting Hourly$200/hour

Optimization and troubleshooting

Platforms We Work With

  • Watson LIMS
  • LabWare
  • LabVantage
  • Benchling
  • Custom solutions
Discuss Your Needs

Documentation Accelerators

Pre-built SOP templates to fast-track your compliance efforts

GxP SOP Packages

Essential GxP

$197

Core documentation for small labs

  • 5 Essential SOPs
  • Basic templates
  • Email support
  • Quarterly updates
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Professional GxP

$497

Complete GxP framework

  • 15 Comprehensive SOPs
  • Advanced templates
  • Priority support
  • Monthly updates
  • Training materials
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Enterprise GxP

$997

Full organizational solution

  • 25+ SOPs
  • Custom branding
  • Phone support
  • Weekly updates
  • On-site training option
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How We Transform Your Data

From handwritten notebooks to AI-verified digital records in four seamless steps

1

Paper Records

Handwritten lab notebooks, batch records, and raw data sheets

→
2

Smart Capture

AI-powered OCR extracts and interprets handwritten data accurately

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3

Structured Data

Clean, organized digital records ready for analysis

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4
21 CFR 11ALCOA+GxP

AI-Verified

Automated compliance checks and audit-ready documentation

50%Time Saved
99.9%Accuracy Rate
100%Audit Ready
24hrTurnaround
See It In Action →

Professional Training Programs

Build expertise across your entire laboratory team

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Data Integrity Fundamentals

Master ALCOA+ principles and 21 CFR Part 11

$1,200/session
Book Training
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cGLP/cGMP Best Practices

Comprehensive compliance training for lab staff

$1,500/session
Book Training
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QC Data Review Mastery

Advanced techniques for bioanalytical data review

$1,800/session
Book Training
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Laboratory Automation

Transform manual processes with smart automation

$2,000/session
Book Training

Why Choose Lab Integrity Pro?

FDA regulatory compliance

Regulatory Expertise

In-depth knowledge of FDA, EMA, and ICH regulations

Antibody drug conjugates

Large Molecule Specialization

Deep expertise in monoclonal antibodies and antibody drug conjugates

Proven laboratory expertise

Proven Track Record

10+ years GxP experience with 100% audit success rate

Practical laboratory solutions

Practical Solutions

Templates and processes that work in real laboratory settings

Not Sure Where to Start?

Let's discuss your specific challenges and find the right solution for your laboratory

Book a Strategy Call