Industries

Built for Your Industry, Not Generic Compliance

QMSdesk™ configures itself to your industry on setup — real regulatory frameworks and role definitions, not the same generic checklist relabeled five ways.

Pharmaceutical

GMP compliance for drug manufacturing operations — batch release, validation lifecycle, and regulatory submission readiness.

EU GMP Annex 11ICH Q7–Q10GAMP 5PIC/S GMP21 CFR 210/211WHO GMP

Includes real regulatory role titles like Qualified Person (QP) and Responsible Person (RP), not generic placeholders.

Medical Devices

Design control and post-market surveillance for device manufacturers — design history files, risk management, and vigilance reporting.

ISO 13485:2016ISO 14971IEC 62304IEC 62366EU MDR/IVDRFDA 21 CFR 820MDSAPUDI

Includes PRRC (Person Responsible for Regulatory Compliance under EU MDR), Design Engineer, and Product Safety Officer roles.

Biotechnology

Quality management for biologics, gene therapy, and advanced therapies — bioprocessing, cell line development, and cold-chain logistics.

GLP (21 CFR 58)GCP (ICH E6 R2)21 CFR 50/56/312EU CTR 536/2014Helsinki DeclarationHIPAA

Includes Principal Investigator (PI), Study Director, CRA, and Bio-safety Officer roles.

CRO / CDMO

Contract research and manufacturing quality management — sponsor quality agreements, tech transfers, and multi-client audits.

ISO 17025:2017GLP (21 CFR 58)GCPGMP21 CFR Part 11

Healthcare Provider

Quality and safety management for healthcare delivery and clinical services — patient safety, credentialing, and clinical pathways.

HIPAAJoint CommissionISO 15224

Includes Clinical Director and Compliance Officer (HIPAA/Privacy) roles.

See exactly how industry packs configure documents, roles, and workflows on setup.

See Industry Packs in QMSdesk

Cross-Industry Solution Themes

eQMS modernization and adoption
CSV/CSA transformation and validation automation
Inspection readiness and audit resilience
Data integrity and compliance governance
Cloud qualification and infrastructure controls
Regulatory strategy and execution support

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