FDA’s transformation towards CSA

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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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FDA’s transformation towards CSA

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Blog & News   |  2020-11-13
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Agile Computer System Validation

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Blog & News   |  2020-10-20
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Getting started with Data Security & Data Integrity

  (Reading time: 5 minutes)   Introduction Learn more about data integrity and how to implement and maintain data integrity within your organization. In this article, we will discuss the following topics: What is......

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Blog & News   |  2020-10-08
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BCF Career Event

  BCF Career Event Netherlands 2020 29 September - Online | 30 September - Utrecht   Rescop will take place again at the largest career event for the Life Sciences in the Netherlands. This year, BCF Career Event will......

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Blog & News   |  2020-09-18
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What is computer system paperless validation (CSV) for Pharma, Medical Devices and Biotech companies?

  Computer System Validation (CSV)/Paperless Validation is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose to ensure compliance with GMP guidelines and to help organizations maintain consistent quality. The......

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Blog & News   |  2020-09-02
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ECA -Academy Computer Validation Seminar

    We are proud to announce that we will be a part of ECA – Academy conference on 27 & 28 - 30 October 2020 as a speaker.   Highlights Regulatory Update Leveraging Suppliers - Managing Quality...

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Blog & News   |  2020-08-03