Continuous compliance: Rather than preparing for audits, agents continuously monitor validation completeness, test coverage, ...

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL. Q. We are a well-established pharmaceutical ...

User requirements form the essential building blocks for IT projects. Use these best practices to make sure you have a good set of requirements for your project. Managing user requirements is a ...

When validating automated systems from third-party providers, using the V model and failure modes effects and criticality analysis (FMECA) early in the process can help. The approach to system ...