Ensure systems compliance with common regulations
As well as complying with regulations surrounding the development and manufacture of pharmaceutical products, life sciences organizations are also obliged to comply with defined guidelines when it comes to the deployment of regulatory systems, e.g. US FDA 21 CFR Part 11, EU GMP Annex 11. Successfully passing an audit from the regulatory agencies requires a validated environment, and the process of evaluating and validating computerized systems comes with its own set of challenges which can be very time consuming and resource intensive.
EXTEDO provides a broad range of Computer System Validation (CSV) services to support client systems. Our team of validation experts have an in-depth knowledge of pharmaceutical, biotechnology and medical device business processes, ensuring a tried-and-tested method of system validation. By utilizing the risk-based approach to compliant GxP computerized systems defined within the GAMP 5 standard, we aim to reduce the time, effort and cost associated with getting your systems up and running.
- Reduce time & resources associated with computer systems validation
- Validation experts execute the entire validation process and produce the necessary documentation
- Guarantee successful regulatory audits
- Tailored validation approach - either standard or customized validation documentation
- Validation documentation available with every release of EXTEDO products.
A trusted validation provider in the global regulatory market
EXTEDO is the only vendor that provides solutions covering the entire regulatory landscape. In addition, our partnership with over 30 regulatory authorities around the world helps us to ensure that we remain on the leading edge of standards development and continually provide the highest-quality solutions. This extensive expertise and inside knowledge enable us to help our customers successfully pass regulatory audits, first time.
EXTEDO delivers agile validation services for its entire software suite. Our computer and software validation process builds on our proven validation framework. This includes SOPs for project-specific validation plans, installation plans and protocols, test plans and protocols, performance qualification and change documents. Utilizing this framework significantly reduces the time spent completing validation.
In addition, all products within the EXTEDOsuite are accompanied by standard CSV documentation covering each release of the software environment. While documentation is provided in English, EXTEDO’s team is also able to offer multi-lingual support for certain regions.
By verifying a controlled implementation of your computer and software systems, EXTEDO ensures that your organization maintains its integrity, provides reliability, and guarantees the availability of regulated business data. Together, we ensure the production of quality pharmaceutical products and protect patient safety.