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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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Blog and News
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ISPE GAMP Forum - Computerized and Automated Systems

  We are proud to announce that we will be a part of ISPE – GAMP Forum on 18-19 May 2021 where Rafał our Principal csv consultant is a speaker.                                                            Agenda   ...

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Blog & News   |  2021-05-07
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Verification & validation (V&V) in software testing– what is the difference?

  What is the difference between verification and validation in software testing? Verification answers the question, “Did we build the right software?*” while validations addresses, “Did we build the software right?*”     Verification versus......

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Blog & News   |  2021-04-29
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GAMP5 - The Good Automated Manufacturing Practices (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture

  In this article we will share examples of GAMP software categories that are related to The Good Automated Manufacturing Practices (GAMP5) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.  But before we start, what......

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Blog & News   |  2021-03-29
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Software validation - GAMP 5 based Computer System Validation (CSV)

  Our Principal Consultant Richard Mulders led the ‘Discussion Forum’ at the Eurachem General Assembly in May 2020 and also presented diverse workshops on Computer System Assurance and Validation of Computerized Systems in a risk-based way,......

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Blog & News   |  2021-03-09
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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