Certifications and regulatory compliance

Accevo MES/MOM is engineered for regulated manufacturing: pharma, FMCG, tobacco, automotive and more. Data integrity and traceability decide whether your product ships or your line stops.

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3 x ISO certified

ISO 9001 quality, ISO/IEC 27001 security and ISO 22301 business continuity, independently audited.

Pharma-grade compliance

21 CFR Part 11, EU GMP Annex 11, ALCOA+ and GAMP 5, the sttrictest regime we build to.

CRA & NIS2 ready

Security by design, a working vulnerability process and supplier evidence, ahead of the EU dealdines.

6 regulated industries

Pharma, FMCG & food, tobacco, packaging, automotive and aviation, on a single compliance core.

The next audit won't wait for your legacy MES

Regulatory requirements for manufacturing software are tightening on a fixed schedule. Systems designed a decade ago, or built as in-house custom code, were rarely built with today’s EU requirements in mind.

 

NIS2

Manufacturers across pharma, FMCG, automotive and aviation are classified as essential or important entities. They must prove cybersecurity across their software supply chain, including the MES.

CRA reporting obligations

Manufacturers of software with digital elements must report actively exploited vulnerabilities and severe incidents. Your MES vendor has to run that process today.

CRA full application

Secure-by-design, SBOM transparency and defined support periods become market-access requirements in the EU. Legacy platforms without a compliance roadmap face end-of-life.

Modern compliance, without the multi-year migration

Replacing a legacy or custom-built MES usually gets postponed because the transition feels risky. Accevo is designed to make it low-risk.

Fast implementation

Accevo is a configurable product platform. Standard modules, a proven implementation methodology and pre-built validation documentation put go-live in months.

Compliant with current requirements

21 CFR Part 11, EU GMP Annex 11, ALCOA+ data integrity and GAMP 5, plus readiness for CRA and NIS2. We keep the platform current as regulations change.

Configuration that replaces custom code

Workflows, screens, batch records and quality checks are set up by configuration. The custom processes that locked you into your old system become standard, upgrade-safe configuration.

Bring your history with you

Structured import of master data, genealogy and historical records from legacy systems, so audit trails and product history stay intact and retrievable after migration.

Everything an auditor will ask about

We build to the strictest regulatory regime in manufacturing, pharmaceutical GMP. Every other industry we serve inherits that rigor: the same audit trails, data integrity and validation discipline.

Certificaciones de la empresa

ISO 9001 – un sistema de gestión de la calidad certificado que abarca el desarrollo, la entrega y el soporte técnico.

ISO/IEC 27001 – Gestión de la seguridad de la información certificada; tus datos de producción están protegidos por controles de seguridad auditados de forma independiente.

Comprueba quiénes somos – Copias de certificados, declaraciones de alcance y pruebas de auditoría relativas a la cualificación de sus proveedores, disponibles en cualquier fase de la evaluación.

Pharma regulatory compliance

21 CFR, Parte 11, de la FDA y el Anexo 11 de las BPF de la UE – secure audit trails, unique user authentication, role-based access and electronic signatures with meaning and manifestation.

ALCOA+ por diseño – cada registro debe ser atribuible, legible, contemporáneo, original y preciso, con un historial completo de cambios que conserve todos los valores anteriores.

Registros electrónicos de lotes – Revisión por excepción, flujos de trabajo obligatorios y genealogía completa de los lotes para agilizar el lanzamiento, con pleno cumplimiento de las buenas prácticas de fabricación (GMP).

Validation support

Ajustamiento a GAMP 5 (2.ª edición) – Desarrollado e implementado como un producto configurable, lo que permite un enfoque de validación simplificado y basado en el riesgo.

Compatibilidad con CSV/CSA – Paquetes de documentación de validación estándar, trazabilidad de los requisitos y apoyo en la ejecución de IQ/OQ/PQ.

Cambio controlado: gestión documentada de las versiones y los cambios de la propia plataforma.

One compliance core for every regulated industry

The same core of audit trails, traceability, enforced workflows and electronic records, configured to the regulations and customer requirements of your sector.

Pharmaceutical & Life Sciences

Electronic Batch Records, review-by-exception and GMP-grade data integrity for licensed manufacturing, packaging and parallel import operations.

FMCG & Food

Lot-level traceability, quality checks at the line and recall readiness in minutes, supporting your food safety certifications and retailer audits.

Tabaco

Serialization and track & trace aligned with EU Tobacco Products Directive requirements, with unit-to-pallet aggregation and reporting integration on the production line.

 

Automoción

Full product genealogy, enforced process interlocking and complete quality records, the evidence base your IATF 16949 system and OEM audits demand.

Aviación

Part-level genealogy, operator certification control and airworthiness-grade records retention, supporting AS/EN 9100 quality systems and authority audits.

Embalaje

Material and lot traceability across converting and filling lines, customer-specification enforcement and audit-ready quality documentation.

Security built in before the first login

Security is embedded from architecture through release. Our ISO 27001-certified development lifecycle includes threat modeling, secure coding, dependency and vulnerability scanning, code review and controlled releases.

The platform ships hardened by default: role-based access with least privilege, TLS-encrypted communication, corporate identity integration (LDAP/AD, SSO), configurable password and session policies, full audit logging, and an architecture ready for IEC 62443 zone-and-conduit network segmentation.

[email protected]

Vulnerability reports from researchers, customers and partners. Customers can also report through the Accevo Jira ticket system.
compliance security

EU Cyber Resilience Act readiness

Secure-by-design SDLC, defined vulnerability handling with security advisories, security updates across the defined support period, SBOM available to customers on request, and reporting processes prepared for CRA notification obligations.

NIS2 for your supply chain

As a trusted supplier to essential and important entities: ISO 27001-audited security and ISO 22301-certified business continuity as evidence for supplier assessments, risk-based security measures, incident response cooperation aligned to your reporting timelines, and a dedicated process for security questionnaires and audits.

Patch & vulnerability management

Documented advisories and managed patching for the Accevo platform, separated from feature releases where needed, so security never waits for a version upgrade.
ISA UPC ISPE

Built on the standards your engineers already use

Accevo integrates enterprise to shop floor through ISA-95 and connects machines through OPC UA for secure, vendor-neutral connectivity. Our approach to digital maturity in pharmaceutical manufacturing follows the ISPE Pharma 4.0 operating model, connecting data integrity, digital plant maturity and workforce enablement into a single roadmap for regulated production.

MES

Find out where your current MES fails the 2027 test

Request a compliance gap assessment. We map your legacy system against Part 11, Annex 11, CRA and NIS2 requirements and show you a realistic migration path.

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MES compliance questions we hear in every audit and RFI

Accevo MES/MOM provides the technical controls required for compliant electronic records and electronic signatures under FDA 21 CFR Part 11 and EU GMP Annex 11: secure, time-stamped audit trails, unique user authentication, role-based access control, electronic signature workflows and record protection throughout retention periods. Final compliance is achieved in your validated environment, which we support with standard validation documentation.

Accevo Sp. z o.o. holds three independently audited management system certifications: ISO 9001 (quality management), ISO/IEC 27001 (information security management) and ISO 22301 (business continuity management).

Yes. Accevo is aligning its product lifecycle with the CRA ahead of its application dates: secure-by-design development, a defined vulnerability handling process ([email protected]), security updates across the support period and SBOM availability. For customers regulated under NIS2, we provide audited supplier evidence, including ISO 27001 and ISO 22301 certification, incident response cooperation and supplier due diligence support.

Yes. Accevo is developed and implemented following GAMP 5 (2nd Edition) principles as a configurable software product, enabling a risk-based, simplified CSV/CSA validation approach with standard validation documentation packages and IQ/OQ/PQ execution support.
Accevo serves regulated manufacturing across pharmaceutical and life sciences, FMCG and food, tobacco (including EU TPD track & trace), packaging, automotive (IATF 16949 support) and aviation (AS/EN 9100 support), on one shared compliance core of audit trails, traceability and electronic records.
Yes. Accevo replaces legacy and custom-built MES systems through fast, configuration-based implementation, structured import of master data and historical records from your old system, and upgrade-safe configuration that replaces custom code, keeping audit trails and product history intact after migration.