Discover the excellence of eCValidation’s CSV Validation services, specializing in comprehensive Computer System Validation for the pharmaceutical, medical devices, biotechnology, and broader life science sectors. With a focus on compliance, data integrity, and critical thinking, our expertise ensures the reliability of your systems.
Our experts follow newest EMA and FDA regulations but are also familiar with “good practices” broadly met on the market, like: critical thinking, lean and agile validation, computerized system assurance (CSA) and new approach to IT tools.-
Data integrity takes center stage in our computer system validation approach. Throughout the validation process, we prioritize the implementation of “control by design” strategies. These encompass validation, audit trails, risk management, personnel and supplier qualification, requirement documentation, data migration, storage and security, incident management, business continuity, electronic signatures, and printers with balances. By integrating these measures, we safeguard the integrity and dependability of your data.
Serialization is another key pillar of our services. Our seasoned team specializes in expertly validating serialization systems, covering Level 1 to Level 4 validations. We also validate interfaces between the Level 4 system and the EU Hub, as well as interfaces with ERP systems. With our support, you can achieve product traceability, prevent counterfeiting, and meet stringent regulatory requirements.
We understand that Software Quality Assurance (SQA) and computerized system assurance (CSA) is vital in the CSV process. Therefore, we uphold rigorous quality standards to ensure your computer systems undergo thorough testing and comply with industry regulations implementing as lean approach as possible to make sure that we really focus on most critical aspects . Our team of experts ensures reliable and efficient Software Quality Assurance, instilling peace of mind in your validation journey.
eCValidation is dedicated to delivering exceptional Computer System Validation services tailored to the pharmaceutical, biotechnology, medical devices, and life science industries’ demanding requirements. Contact us today to explore how we can assist you with computer system validation, data integrity, Serialization, and Software Quality Assurance. Trust our expertise to provide dependable solutions for all your validation needs.
Warranties and Security
We ensure the highest quality service supported by our utmost commitment and expertise in project execution.