BioComply Life Sciences Technology Assurance Get Compliant

BioComply Life Sciences Technology Assurance

compliant systems + audit-ready = faster releases

We help regulated companies pass FDA inspections and deploy compliant software
without delaying product releases.

Regulated technology consulting

Who

Nobody wakes up wanting Computer System Validation. You want FDA approval, clean audits, no warning letters, and faster releases. Validation is how we get you there we sell the outcome, not the paperwork.

We focus on FDA-regulated software validation for biotech startups and small manufacturers the 20-person biotech, the university spin-off, the contract manufacturer preparing for its next inspection. Teams that need practical, audit-ready help without enterprise consulting overhead.

We’re a two-partner practice: regulatory affairs & quality assurance on one side, infrastructure & cybersecurity engineering on the other (Azure-certified, CompTIA Security+). Modern validation lives where the regulation meets the stack MFA, audit logs, backups, encryption, cloud configuration and we speak both languages natively.

We work CSA-forward: the FDA is shifting from traditional CSV toward Computer Software Assurance critical thinking over exhaustive scripting. We test what matters, document what’s required, and use automation to accelerate the repetitive parts with final review always in qualified human hands.

What we do

Services

Validation & assurance

CSV & CSA

Computer System Validation and risk-based Computer Software Assurance validation plans, URS through IQ/OQ/PQ, traceability matrices, and vendor qualification. Documentation that survives inspection.

Compliance & data integrity

Part 11 & ALCOA+

21 CFR Part 11 assessments, GxP compliance consulting, and data integrity (ALCOA+) audits electronic records, e-signatures, audit trails, and the gaps inspectors actually find.

Security & readiness

Cyber, audits & SOPs

Cybersecurity risk assessments, FDA audit preparation, SOP development, and ADA website accessibility audits MFA, backups, audit logging, and encryption reviewed with a validation lens.

What we validate

Systems

Laboratory

LIMS

Laboratory Information Management Systems sample lifecycle, results integrity, audit trails, and instrument interfaces validated end to end.

Laboratory

ELN

Electronic Lab Notebooks Part 11 e-signatures, versioning, witness workflows, and data integrity from first entry to archive.

Manufacturing

MES

Manufacturing Execution Systems electronic batch records, recipe management, and shop-floor data capture under GMP.

Enterprise

ERP

Enterprise Resource Planning GxP-relevant modules, master data controls, and the interfaces where compliance risk hides.

Bench

Lab instruments

Laboratory instrument qualification from standalone balances to networked chromatography data systems.

Cloud & SaaS

Cloud systems

Azure, AWS, and SaaS platforms in regulated use shared-responsibility mapping, vendor qualification, and continuous-release validation strategy.

Same framework, every engagement

Process

Assess

Phase 1

Discovery · Gap Assessment · Risk Analysis

Understand before validating most compliance budgets are wasted testing things that carry no patient or product risk.

  • Discovery map your system landscape, intended use, and data flows across GxP processes.
  • Gap assessment measure current state against 21 CFR Part 11, Annex 11, and data integrity (ALCOA+) expectations.
  • Risk analysis rank findings by patient safety, product quality, and data integrity impact, so effort lands where risk actually lives.

Validate

Phase 2

Validation Plan · Testing · Documentation

Risk-based testing, CSA-style scripted where it matters, unscripted where it doesn’t, documented so the validation holds up in front of an inspector.

  • Validation plan and requirements URS, functional and design specs sized to the system’s actual risk.
  • Testing IQ/OQ/PQ execution with full traceability from requirement to test evidence.
  • Documentation audit-ready as it’s produced: traceability matrix, test scripts, final summary report. If it isn’t documented, it didn’t happen.

Sustain

Phase 3

Training · Audit Readiness · Maintenance

Validated once is not validated forever the state you were inspected in is the state you must stay in.

  • Training and SOPs your team runs the system compliantly after we leave, not just while we’re there.
  • Audit readiness mock inspections, response playbooks, and document retrieval drills before the FDA is in the lobby.
  • Maintenance change control reviews, periodic revalidation, and vendor reassessment as systems evolve.

Monthly Compliance Package

Ongoing retainer: SOP updates, quarterly audits, validation maintenance, change control reviews, and vendor assessments. Predictable compliance at a predictable cost instead of scrambling before every inspection.

Start small, start now

Contact

We serve biotech startups, university research labs, contract manufacturers, and medical device startups especially teams preparing for a first FDA inspection, a Series A/B raise, or a new GxP system go-live.

Not sure where to begin? Start with a gap assessment or an ADA website accessibility audit low-commitment engagements that show you exactly where you stand before you spend on a full validation effort.

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