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.
FvP & Swissmedic
License
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.