Our expertise

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PHARMASYS is a consulting company specialized in engineering, quality, GxP compliance and data integrity for computerized and automated systems.

We operate in the Lifesciences industries: Pharmaceutical, Biotech, Cosmetics and Medical Devices.
We offer tailor-made services in project management, quality assurance, quality assurance, validation and training, based on ISPE guidelines and the CSA (Computerized Systems Assurance) approach.
Our methodology ensures compliance with regulatory requirements like FDA 21 CFR Part 11, CGMP's, ISO 13485, IEC 62304, and others.

Discover our offers

Validation of GxP systems

We support you in the validation of your computerized systems via a robust and adapted methodology, including:

Validation plan

Specifications in GAMP format: requirements (RS), Technical and configuration specifications (TS/CS)

Risk Analysis and Traceability Matrix

Checks and tests (QC/IQ/QO/QP)

Data migration

Infrastructure qualification

Operational and maintenance procedures, in accordance with ITIL best practices.
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We support you on your IT projects carried out in AGILE mode, with an adapted validation methodology.
Our methods follow GAMP5 and CSA approaches to meet Lifescience industry requirements.

Regulatory Compliance, IT QA Process, Audits and Data Integrity

We intervene to ensure the regulatory compliance of your IT systems, with services such as:

Project management assistance, including in AGILE mode.

Compliance audit (Data Integrity, 21 CFR Part 11, GxP, GAMP5) of computerized systems, organizations and IT suppliers.

Implementation of a Quality System and Validation Procedures: Validation Master Plan, Quality Procedures, Process Mapping.

Formalization of user needs (RS).

Assistance in preparing FDA, ANSM, MHRA inspections...

Assistance in the implementation of compliant processes Data integrity, GXP's, GAMP5: Change Control, Operational Continuity, Periodic System and Process Reviews, Trail Audit Reviews...

Digitizing the validation process

PHARMASYS vous accompagne dans votre projet de déploiement et d’optimisation de solution ALM ™. 

Une solution collaborative, complète et personnalisable de gestion du cycle vie des applications (ALM), incluant la gestion des exigences et la gestion des tests pour une digitalisation totale du cycle de vie de vos applications GxP.

Deployment by PHARMASYS includes

Installation and configuration

Definition and customization of models

Setting up a pilot project

User assistance and support

Full validation of the ALM™ solution

We work with publishers who offer unified solutions that meet project and regulatory challenges.

Collaborative management of business, quality and IT requirements.

Dynamic traceability from requirements to tests.

Respond to audits and inspections

Manage the progress of each project through management dashboards

Maintaining the validated state and managing the Change Control processes.

Test automation.

Meet 21 CFR part 11 requirements

Flagship features

Define and manage requirements

Risk analysis management and dynamic traceability matrices

Test Management

Collaboration with Office (Word, Excel) in import/export mode

Management of builds and releases, changes and impact analyses

Management of anomalies.

Project monitoring with dashboards and KPIs.

Our expertise

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Production or planning solutions (ERP-GPAO-SCM-MES)

SAP S4Hana, Sage, JDE, Dynamics, QAD, QAD, Reflex, Reflex, Dispatcher, TMS, GP2, B2U, Octalsoft, Rockwell, Werum, Werum, Dynamics, QAD, QAD, Reflex, Reflex, Dispatcher, TMS, GP2, B2U, Octalsoft, Rockwell, Werum, Werum