Proofreading built for regulated artwork

InformaIT is certified according to ISO 27001:2022, the international standard for Information Security Management Systems (ISMS). This certification confirms a structured, risk-based approach to protecting information—preserving confidentiality, integrity, and availability—and shows that security is managed and continuously improved through defined controls, processes, and regular audits.

GAMP Good Practice Guide Enabling Innovation and GAMP 5 Second Edition aims to ensure best practices regarding current strategies and industry standards. The guides cover agile development strategies, critical thinking, and the effective use of software tools – all essential best practices for InformaIT as a provider. It highlights that innovation is crucial in delivering value to society, managing costs, reducing time to market, and ultimately, enhancing and saving lives. InformaIT follows the guidelines applicable to being a supplier for regulatory businesses.

At InformaIT, we comply with FDA’s 21 CFR Part 11 regulations, ensuring our proofreading software meets stringent electronic records and signature standards. The software is rigorously validated to guarantee reliability, integrity, and security, supporting audit trails, secure access, and electronic signatures. This adherence safeguards data integrity and confidentiality and streamlines regulatory processes.

At InformaIT, a Release Qualification is performed when a new version of Content Compare is released. Using a risk-based approach, the Release Qualification means that the standard software's functionality is already validated when implemented by the customer. The documentation of the Release Qualification is available for our customers in a validation package, including a test plan, risk assessment, test report, and the executed test cases.