Insights

Planned first pieces

• EU MDR and IVDR: what the current deadlines actually mean for legacy devices
• What a compliant I-9 and E-Verify onboarding looks like, and why clients ask
• W2 versus C2C versus 1099 in life sciences contracting, explained for hiring managers
• Life sciences hiring market: what specialist roles are really taking to fill
• Risk-based monitoring: where sponsors still over-invest in SDV
• Five compliance problems that turn up in almost every computerised system validation
• What the second edition of GAMP 5 changed, and what it did not
• 21 CFR Part 11 for computerised system validation, without the jargon
• Where Computer Software Assurance genuinely reduces effort, and where it does not
• How contract specialists shorten a delayed programme, with the trade-offs stated plainly