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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
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.
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.
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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Medical Devices

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Cloud Computing in a GxP Environment Live Online Training

  We are proud to announce that we will be a part of ECA – Academy conference on 24-26 February 2021 as a speaker.   Highlights   Compliance Requirements for Cloud Computing Inspectors‘ / Regulators‘ Expectations and Findings During Inspections Types of......

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Blog & News   |  2021-02-17
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GMP Certification for Medical Cannabis

  What is medicinal cannabis? Medicinal cannabis (medicinal marijuana) is cannabis and cannabinoids that are prescribed by physicians for their patients. The medicinal cannabis obtained from a pharmacy is a standardized product that meets strict quality requirements. This......

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Blog & News   |  2021-02-15
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Rescop free webinars/demos of our validation lifecycle management and quality management software

  An Industry StandardRescop is the digital paperless pioneer in a GxP Compliance world. Founded in 2005, Rescop Quality Management Suite (RC-QMS) is used by companies worldwide, spanning all industries, platforms and......

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Blog & News   |  2021-02-11
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Rescop free Webinar training

Rescop free Webinar training   Our SME’s are happy to announce that they will give free webinars again. After the success of last year, we would like to give more people the opportunity to follow those......

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Blog & News   |  2021-02-11
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What is data integrity?

    Data integrity is the maintenance of, and the assurance of, the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Integrity......

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Blog & News   |  2021-01-04
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FDA’s transformation towards CSA

  The pharmaceutical industry is currently undergoing an exciting transformation areas. Medical and biotechnological innovations happen very fast, research and development processes are under constant investigation for improvement and business and sales models are changing.  In this......

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Blog & News   |  2020-11-13