Regulations
Your industry has specific compliance obligations
Whether you operate under FDA 21 CFR Part 11, EU GMP Annex 11, ISO 13485, or GxP — Complere speaks the language your auditors use.
Regulated Industries
Quality Management Built for Your Industry
Configured for the regulations, workflows, and inspection expectations of each regulated market
Complere is configured for the specific regulatory frameworks, inspection expectations, and operating models of pharmaceutical, medical device, healthcare, and adjacent life sciences industries — so messaging, examples, and controls map to how you are regulated, not a one-size-fits-all SaaS story. Every sector page ties back to audit confidence: inspection-ready proof, traceability, and readiness as a habit.
Industry Challenges We Address
The quality and compliance pressures unique to your regulated market — and how Complere is built to address them.
Operations
Quality workflows vary by operating model
CAPA, document control, training, and audits are universal, but the triggers, evidence standards, and escalation patterns differ by industry.
Inspection Readiness
Every market has a different inspection cadence
Pharma, device, and CRO teams face different inspector expectations — and Complere's compliance controls are configured accordingly.
Explore by Industry
Choose your sector to see the regulatory context, quality workflows, and module recommendations most relevant to your team.
Pharmaceutical Manufacturing
GMP, FDA 21 CFR Part 11, EU GMP Annex 11, ALCOA+.
Medical Devices
ISO 13485, ISO 14971, and FDA quality system controls.
Healthcare & Laboratories
Data integrity, training evidence, and audit discipline.
Nutraceuticals & Supplements
cGMP compliance and quality documentation at scale.
CMO / CDMO
Multi-client quality records, client visibility, and validation.
Clinical Research & CROs
GCP study documentation, site oversight, and sponsor reporting.
Regulatory Frameworks Covered
The primary frameworks that govern quality systems in the industries Complere serves.
Regulatory Area
Pharma and Biotech
FDA 21 CFR Part 11 • EU GMP Annex 11 • GxP and ALCOA+
Learn moreRegulatory Area
Medical Devices
ISO 13485 • ISO 14971 • FDA quality controls
Learn moreRegulatory Area
Healthcare and Labs
Data integrity • Training and competency • Audit discipline
Learn moreCore Modules Across All Industries
These Complere modules underpin quality compliance regardless of your regulatory framework.
Relevant Module
Document Control
Controlled SOPs, work instructions, and forms with versioning and e-signature approvals — core to every regulated industry.
Learn moreRelevant Module
CAPA & Deviations
Routed deviation intake, root-cause investigation, and effectiveness verification that every quality system must handle.
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Audit Management
Plan internal, supplier, and regulatory audits from one backlog — findings link to CAPAs with closure evidence.
Learn moreRelevant Module
Training & Competency
Role-based curricula tied to controlled documents, with competency sign-off feeding the inspection-ready training record.
Learn moreReady to see Complere in your industry context?
Our demos are tailored to your regulatory framework, operating model, and the quality workflows that matter most in your market.