GxP QUALITY ASSURANCE

Today GxP professionals are facing growing challenges: drugs, vaccines and medical devices are getting more complex. Health Authorities are evolving their requirements and increasing monitoring. Reporters, social media and public opinion are expanding their expectations on any activity or communication from the Industry.

QMS Design, Authoring and Revision

We are able to create a QMS from scratch or to assess, improve and revamp any already existing one.

Auditing and Due Diligence

We are expert auditors capable of working on plan, agenda, reports and CAPA for vendors, partners and affiliates.

Inspection Readiness and Remediation

We review reports and CAPA status, we run organization assessment, mock interviews and suggest remediation activities post inspections.

Training, coaching and QA back-up

We prepare training and coaching sessions for your team and provide you with a backup during transitional or busy periods.

EU GDPR Compliance in R&D

We align processes and verify documentation to ensure EU GDPR is respected and data processors are compliant.

Responsible Person Services

We establish QMS, submit Swissmedic license requests, support you during licensure processes and FVP activities.

TECHNOLOGY

The world is running. Innovation once was a plus, but today it is a must. Epiqure supports clients in welcoming innovation in their organization, helping them in assessing and implementing systems and automations.
Our mission is to improve the quality of processes and optimize productivity.

Technology Assessment

We analyse your processes and electronic systems in order to identify areas that could be improved or at risk of non-compliance.

Computer System Validation

We acknowledge your QMS and adapt your validation framework to ensure a successful deliverables integration and UAT execution.

Change Control & Management

We ensure the maintenance of your validation status, libraries, code lists, configuration and customization, during your updates.

Vendor Selection & Qualification

We qualify vendors supporting your ITC and Procurement teams in making the most appropriate choices for your business.

Project Management

We coordinate e-systems implementations or upgrades from an operational perspective including budget and vendor management.

Bottom-top Technology services

We deploy Argus implementations, migrations, custom reporting, AWS hosting or any other tool to automate Data Migration and Case Intake.

Epiqure AG - Martinsgasse 20, 4051 Basel, Switzerland | Epiqure France SAS - 6 rue Freycinet, 75116 Paris, France