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EcoSoftwareQuality (EcoSQ) is an efficient method for Computer Software Assurance/Validation (CSA/CSV) that guarantees compliance for the Pharmaceutical Industry (GxP), Medical Devices and other regulated Life-Science.

• Compliant

It is proven to be fully compliant with EudraLex Volume 4 GMP Annex 11 and FDA 21 CFR Part 11 and in line with the latest practices such as ISPE GAMP® 5 Second Edition (July 2022) and the FDA Draft Guidance on CSA (September 2022), supporting modern Agile and ITIL developments, use of digital tools and cloud and SAAS solutions.

• Efficient

All regulations and many years of experience is processed into templates. When used correctly the documents inherit all compliancy and efficiency automatically. It proved to reduce mean 50-75% of CSV time, costs and documentation. Compared to traditional and excessive practices, the reduction of energy, data and paper will also less burden the environment.

For an explanation of the 8 main benefits, goto Free Article (originally published in Pharmaceutical Engineering iSpeak Blog 1 May 2023. © ISPE 2023. All rights reserved. Reprinted with permission).

• No CSV experts needed

With EcoSQ you don’t need CSV experts or a lot of CSV experience. For the validation role you may employ a colleague changing jobs or reintegrating or combine with a user role.

To experience the benefits, goto Free Validation Plan

• Quality Management System

The EcoSQ approach is controlled by a CSV Quality Management System (QMS) consisting of a Policy (POL), Standard Operating Procedures (SOP) and Templates (TPL).

EcoSQ can easily be integrated into the overall QMS or Validation Master Plan (VMP). A simple integration instruction is part of the approach. The templates can be used immediately after authorization. It can also replace (parts of) an existing CSV approach which is outdated, not consistent or not efficient.

For more details about the QMS, goto Services