FAQ Validation

Frequently Asked Questions

1Why paperless validation?
Paperless validation is an electronic method of ensuring that equipment, software, spreadsheets, utilities, cleaning, and processes, including the series of tests in life science companies, are compliant to regulatory bodies such as FDA, EMA, and WHO.
2What is Computer System Validation in pharmaceutical?
Computer System Validation proves with documentation that computerized systems used in pharmaceutical companies adequately fulfill their automatic functions and contribute to ensure the traceability of produced batches with quality and reproducibility.
3What is IQ?
Installation Qualification (IQ) aims to verify and document system installation conditions and if the IQ complies satisfactorily with the requirements previously approved in technical specifications.
4What is OQ?
Operation Qualification (OQ) aims to reference, verify, and document the system operating conditions in a quality environment, and if the OQ complies satisfactorily with predefined requirements for its operation.
5What is PQ?
Performance Qualification (PQ) still aims to reference, verify, and document that a computer system or piece of equipment, after being installed on production, contains a properly parameterized environment, and that the PQ meets satisfactorily the predefined requirements by the User Requirements Specification and/or Functional Specification.
6What is GxP validation?
GxP is a general term for the application of good practices. The 'x' indicates the area in which good practices are related (manufacturing, distribution, clinical research, laboratory, etc.). GxP relevant has impact on: Patient Health, Product Quality and/or Data Integrity.
7What is CSV compliance?
A documentation process that ensures the integrity of data, related to computer system validation (CSV), including software in IT, QC labs, and industrial automation systems. This enables complete traceability of information and proof of compliance, with standards and requirements of the main regulatory bodies of the world (Guidelines to GMP Volume 4 - European Commission; EMA Annex 11; 21 CFR Part 11, etc.), as well as production optimization. This almost always reduces costs and increases the quality of the final product.
8How to adopt a paperless validation solution for life science?
We recommend a gradual change of process that is not abrupt. This allows companies to smoothly migrate validations to GO!FIVE™ after purchase. In this way, companies make the most of the software without negatively affecting their current processes.
9Is there paperless validation in the pharmaceutical industry?
Yes, all steps of the validation process in the pharmaceutical industry can be registered in digital documents rather than on paper (e.g., in the traditional computer system validation FDA format). By not using a single sheet of paper, paperless validation presents many benefits to companies, professionals, and the environment. Almost always the process is sped up at least 4 times when compared to traditional paper validations.
10Is the paperless validation system a magic bullet?
GO!FIVE® is a balanced software platform. It reduces repetitive and mechanical activities, leaving the thinking activities like Risk Assessment and Testing Strategies for the validation specialist to determine. It contains libraries which are a compilation of all knowledge acquired by FIVE in more than 1000 validation projects. However, the validation specialist always has the power to decide if these items adhere with your specific, common practices; not starting from scratch with every new project, saving valuable time and producing validations at least 4x faster.