Our expertise

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PHARMASYS is a consulting company dedicated to the engineering, quality, GxP compliance and Data Integrity of computerized and automated systems in the Lifesciences industries: Pharmaceutical, Biotech, Cosmetic, Medical Devices. 
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We provide project management support, quality assurance, validation and training services.
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Our interventions are based on methods that have been optimized thanks to our many years of experience.  

They are rigorously based on the ISPE (R) guidelines. They make it possible to respond pragmatically to regulatory compliance: FDA, 21 CFR Part 11, FDA, 21 CFR Part 11, CGMP's, BpX, Data Integrity guidances, 21 CFR Part 820, CE Mark, CE Mark, ISO 13485, ISO 13485, ISO 13485, ISO 13485, ISO 13485, ISO 14485, ISO 14971, ISO 14971, IEC 62304...

Discover our offers

Validation of GxP systems

Our expertise, our robust and proven methodologies and the quality of our stakeholders allow us to support you effectively for your validation file:

Validation plan

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

Risk Analysis and Traceability Matrix

Checks and tests (DQ/IQ/OQ/PQ)

Data migration

Infrastructure qualification according to ITIL best practices

Operational and maintenance procedures. We also support you on your IT projects carried out in AGILE mode, with an adapted validation methodology

Regulatory Compliance, IT QA Process, Audits and Data Integrity

Our expertise, our robust and proven methodologies and the quality of our stakeholders allow us to support you effectively for your validation file:

Project management assistance, including in AGILE mode

Compliance audit (Data integrity, 21 CFr Part 11, GxP, GAMP5) of systems, organizations and suppliers by IRCA certified auditors

Implementation of a Quality System and validation procedures: Validation Master Plan, Quality Procedures, Process Mapping... in accordance with GxP requirements, Data Integrity guidelines and GAMP5 methodology

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

Assistance in the formalization of user needs (RS)

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

Digitizing the validation process

PHARMASYS supports you in your ALM™ solution deployment and optimization project. 

A collaborative, complete and customizable application lifecycle management (ALM) solution, including requirements management and test management for a total digitization of the life cycle of your GxP applications.

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.

Manage requirements in a collaborative and shared mode (between business teams, QA, IT, IT services partners or integrators)

Manage dynamic traceability from business requirements to tests

Respond to audits and inspections

Manage the progress of each project through management dashboards

Properly manage the maintenance of the validated state and the change control process

Managing dynamic regulatory bases

Moving towards 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

Change Management and Impact Assessments

Management and follow-up of anomalies

Build and release management

Management of compliance and regulatory bases

Management of workflows, tasks, projects and schedule monitoring

Management: metrics (KPI, dashboards...) and audit,...

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

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LIMS and Laboratory Systems

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lS R&D (Regulatory Affairs, Clinical Trials and Pharmacovigilance)

Argus, Aris-G, Oracle Clinical, eCTD Manager, eCTD Manager, Veeva Vault, SAS, R, Clinsight...

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Industrial computing

Aveva, Rockwell, Siemens, Honeywell, Honeywell, Emerson DeltaV, InSQL, iHistorian...

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Transverse applications (PLM, EDMS, QMS, Analytics and statistical tools)

TrackWise, Documentum, Ennov, Veeva, Veeva, Veeva, Vdoc, Vdoc, Ennovia, Cornerstone, BO, PowerBI, Cognos, SAS, R, SAS, R, SharePoint...

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Infrastructure and IT best practices

Infrastructures, Best Practices and IT Methodologies: GAMP5, LSo9001, LSo27001, Cobit, CMMI, ITIL, SPICE, SPICE, Agile methodologies...

Our expertise

Validation of GxP systems

Regulatory Compliance, IT QA Process, Audits and Data Integrity

Digitizing the validation process

Deployment by PHARMASYS includes

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

Flagship features

Our expertise

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

LIMS and Laboratory Systems

lS R&D (Regulatory Affairs, Clinical Trials and Pharmacovigilance)

Industrial computing

Transverse applications (PLM, EDMS, QMS, Analytics and statistical tools)

Infrastructure and IT best practices

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Our expertise

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