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Global COVID-19 Medicine and Vaccine Monitor

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GMP CERTIFICATION FOR MEDICAL CANNABIS

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DO YOU NEED HELP WITH FDA REMEDIATION?

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GXP Compliance Services & Solutions
01 Qualification & Validation
Our international team of qualified experts is available for all your needs related to qualification and validation. We are preferred supplier for GxP regulated customers by worldwide everywhere on the website. Our services range from hands-on support to the development or improvement of the qualification and validation approach. Methodologies include GAMP 5, ASTM E2500 and agile validation
02 Auditing & Assessments
Our certified auditors perform internal and external audits based on applicable international GxP standards. To prepare for governmental inspections, our auditors can perform a mock audit. We can perform assessments of existing quality management processes to determine their maturity and identify potential efficiency improvements.
03 Quality Management
Our GxP Consultants support in establishing the required quality management processes, including design of quality management policies, procedures and work instructions. Furthermore, we train personnel in the application of the quality management system. Our consultants assess existing quality management systems and support with efficiency and maturity improvements. We also supply interim personnel to support quality operations, including quality officers, CAPA investigators, quality engineers, etc.
04 FDA Remediation
Upcoming FDA inspection? Our GxP consultants support in preparing for inspections by performing assessments of existing processes and performing any required improvements. A CAPA Plan is designed to define and monitor the improvements actions. Our consultants can support during the actual inspection and help with the remediation of any observations.

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2000
PROJECTS
120
EMPLOYEES
200
HAPPY CLIENTS
64
ACTIVE IN COUNTRIES
We provide high quality and cost effective services.

FDA Remediation - 10 years Experience

Data Integrity - 11 years Experience

GMP Certification - 10 years Experience

CSV - 12 years Experience

Our

Clients

Our

Industries

Pharma / Biotech

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Medical Devices

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GxP Laboratories

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Medical Cannabis

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Diagnostics

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Related Markets

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Latest

Blog and News
RC-QMS - NEW LABEL FEATURE
RC-QMS - NEW LABEL FEATURE
   |   2020-04-06   |   Blog & News

RC-QMS RC-SLM - NEW LABEL FEATURE!! Our new "Labels" feature allows printing labels for systems using RC-SLM suite. Labelling helps identify and track down: Calibration schedules Maintenance information Much more......

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Global COVID-19 Medicine and Vaccine Monitor
Global COVID-19 Medicine and Vaccine Monitor
Bjorn Aalbers   |   2020-03-19   |   Blog & News

RC-Intel Global COVID-19 Medicine and Vaccine Monitor   Being active in the healthcare industry, we received many questions from our family and friends about our expectations regarding a......

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The future of Computerized System Validation (CSV)
The future of Computerized System Validation (CSV)
Adriaan Wanner   |   2020-03-12   |   Blog & News

The future of Computerized System Validation (CSV) According to the FDA a lot of pharmaceutical companies are struggling how to embrace the new ways of working......

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Cloud Computing in a GxP Environment - 26-28 February 2020 | Berlin, Germany
Cloud Computing in a GxP Environment - 26-28 February 2020 | Berlin, Germany
Maurice Kerens   |   2020-02-18   |   Blog & News

  We are proud to announce that we will be a part of ECA – Academy conference on 26-28 February 2020 as a speaker. Our Chief Technology......

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