Custom Software for Biotechnology & Pharma
Secure, flexible, and compliant architecture tailored for the unique challenges of the Biotechnology & Pharma sector.
Quick Answer
In short: ERPStack builds custom, secure, and compliant B2B software systems for the Biotechnology & Pharma sector, featuring dedicated cloud deployment, zero per-seat licensing, and complete source code ownership.
Why Custom ERP for Biotechnology & Pharma?
Operating in the Biotechnology & Pharma sector requires a systems architecture designed for high scalability, operational flexibility, and strict regulatory compliance. Standard off-the-shelf software forces your teams to reshape their workflows to fit rigid software packages. A custom ERP for the Biotechnology & Pharma industry maps directly to your exact business logic. Deployed to your secure cloud infrastructure (AWS or Azure), the system isolates database schemas, automates redundant reporting tasks, and scales without user seat licensing fees. This ensures your corporate data remains under your absolute control, eliminates vendor lock-in, and lowers long-term operational technology costs by up to 70% over a 3-year period.
Industry Pain Points
- FDA 21 CFR Part 11 audit failures
- Insecure patient trial databases
- Lack of structured clinical logs
- Unverified data entry signatures
Engineering Blueprint
Biotech platforms manage sensitive clinical trial data. We deploy application-level column encryption and isolated databases.
Our Solutions
- Dual-signature authentication portals
- Application-level column encryption
- Veeva Vault clinical sync API
- Tamper-evident audit log streams
Compliance & Security
Enforces FDA 21 CFR Part 11 guidelines, incorporating dual-signature authentication and tamper-evident audit trails.
Compliance Checklist
- FDA 21 CFR Part 11 Verified
- HIPAA Verified
- HITRUST Verified
- GDPR Verified
- SOC 2 Type II Verified
Get the Blueprint
Download our comprehensive Systems Architecture Blueprint to see how we architect compliant solutions.
Download BlueprintMetrics & Integrations
Illustrative engineering targets for this sector — the SLAs and capacities we design and build toward, not a live service dashboard.
Patient Data Encryption
Compliance Audit Score
Record Retrieval Latency
Integration: Veeva Vault
Integration: Redis Cache
Implementation Process
FDA Compliance Audit
Reviewing clinical trial workflows against Part 11 requirements.
Secure Vault Integration
Mapping clinical records to secure document databases.
Dual Signature Setup
Enforcing MFA and signature validation rules for clinical entries.
Penetration Testing
Validating security enclaves against data leakage scenarios.
Frequently Asked Questions
Every trial entry requires active MFA validation and generates cryptographic signatures matching FDA guidelines.