Biotechnology Industry
Driving Innovation in Life Sciences Through Reliable Software Validation
The biotechnology industry is transforming modern medicine, agriculture, and environmental science. In healthcare, breakthroughs such as cell and gene therapies, recombinant proteins, and monoclonal antibodies (mAbs) are revolutionizing patient treatment. These products are often highly sensitive, complex to manufacture, and subject to stringent global regulations. At GMP Navigator, we help biotechnology companies ensure their computerized systems are validated to manage critical functions—such as cell culture control, fermentation monitoring, bioprocess optimization, quality management, and traceability—with precision, compliance, and reliability.
Products We Support
Cell and Gene Therapies
Cutting-edge treatments that use living cells or genetic material to prevent, treat, or cure disease.
Require precise environmental control, high data accuracy, and robust quality documentation throughout development and manufacturing.
Examples: CAR-T therapies, Stem cell therapies, CRISPR-based gene editing products
Recombinant Proteins
Proteins produced through genetic engineering in host cells, enabling large-scale production of therapeutic proteins. Critical processes include expression system management, purification, and quality testing.
Examples: Human insulin, Growth hormones, Erythropoietin (EPO)
Monoclonal Antibodies (mAbs)
Laboratory-produced molecules designed to target specific antigens for diagnostic or therapeutic use.
Manufacturing involves controlled cell lines, bioreactors, and purification systems under strict GMP compliance.
Examples: Trastuzumab, Adalimumab, Rituximab
Applicable Regulatory Guidelines
Our validation strategies align with the key global regulations governing biotechnology manufacturing:
- FDA 21 CFR Part 600–680
Biological Products – Sets requirements for the manufacturing, testing, and labeling of biologics.
- FDA 21 CFR Part 1271
Human Cells, Tissues, and Cellular- and Tissue-Based Products (HCT/Ps) – Addresses donor eligibility, processing, and tracking requirements.
- FDA 21 CFR Part 11
Electronic Records and Electronic Signatures – Governs the secure and compliant use of electronic systems in regulated biotech processes.
- EU Annex 2
Manufacture of Biological Active Substances and Medicinal Products for Human Use – Covers specific GMP requirements for biologics manufacturing.
- EMA Annex 11
Computerized Systems – Ensures computerized systems used in manufacturing and QC are validated and secure.
- ICH Q5A–Q5E
Quality of Biotechnological Products – Guidelines for safety evaluation, stability, comparability, and viral safety of biotech products.
- ICH Q9 & Q10
Quality Risk Management and Pharmaceutical Quality System – Frameworks for managing risk and maintaining robust quality systems in biotech manufacturing.
- GAMP 5
Good Automated Manufacturing Practice – A risk-based approach for validating computerized and automated systems.
Why Software Validation Matters in Biotechnology
Biotech manufacturing relies heavily on precise process control, real-time data capture, and comprehensive documentation. Even minor deviations can impact critical quality attributes (CQAs) and jeopardize product safety or efficacy.
Software validation ensures that systems—such as LIMS, MES, ERP, QMS, WMS, and SCADA—perform as intended, safeguard data integrity, and maintain compliance with global regulations.
Benefits of Software Validation for Biotechnology
- Regulatory Compliance
- Meet FDA, EMA, and ICH standards for biologics and cell-based products
- Ensure readiness for audits and regulatory submissions
- Process Control & Data Accuracy
- Maintain precise records for controlled environments, fermentation, and purification steps
- Ensure accurate documentation of process deviations and corrective actions
- Product Quality & Patient Safety
- Demonstrate compliance with CQAs
- Avoid contamination risks and process variability
- Traceability & Documentation
- Maintain clean, traceable batch and raw material records
- Support end-to-end product lifecycle tracking
- Risk Mitigation
- Identify and address issues before they impact product safety or efficacy
- Reduce the risk of recalls or regulatory penalties
- Efficient Regulatory Submissions
- Facilitate faster, cleaner, and more transparent data packages for health authority reviews
Partner with GMP Navigator
Whether you're developing a next-generation biologic, scaling up production of monoclonal antibodies, or preparing for regulatory submission, GMP Navigator delivers end-to-end software validation services tailored for biotechnology operations.
Why Choose GMP Navigator?
Trust GMP Navigator, because validation should always be right.
- End-to-End Validation - Comprehensive support from User Requirements (URS) to Final Validation Reports.
- Multi-System Expertise - Proven experience with ERP, QMS, WMS, MES, and other critical systems.
- Global Regulatory Compliance - Alignment with FDA, GAMP 5, 21 CFR Part 11, Part 210/211, Part 820, FSMA, and more.
- GAMP 5-Compliant Documentation - Risk-based, audit-ready documentation that meets industry standards.
- Flexible Engagement Models - Choose from Validation Toolkit, Complete Software Validation, Validation-as-a-Service (VaaS), Gap Assessments, and Training.
- Experienced Cross-Functional Team - Deep domain knowledge in regulations, ERP systems, and industry processes.
- Reliable, On-Time Delivery - Projects completed on schedule and within budget, every time.
Services We Offer
Our flexible engagement models are designed for businesses of all sizes.
Complete ERP Software Validation
Complete end-to-end ERP Software Validation
Validation Toolkit
Ready-to-use templates aligned with norms like FDA & GAMP 5
Complete QMS Validation Services
Complete end-to-end QMS validation service
Validation-as-a-Service (VaaS)
Ongoing validation & monitoring for contract-period
Gap Assessments & Training
Identify gaps, train your team, and always stay compliant