Pharmaceutical & Healthcare
IT for pharmaceutical and healthcare companies
Pharmaceutical manufacturers, laboratories and clinics run on systems that inspectors read as closely as auditors read the books. We build and run IT that is validated, documented and ready for inspection.
The challenges
What keeps IT teams up at night
- Computerized systems that must be validated, and stay validated after every change
- Data integrity under ALCOA+: audit trails, electronic signatures, backups that restore
- Patient and research data that must stay private
- Production and lab equipment that cannot stop for an update
What we do
How QROQ answers them
- Validation of computerized systems by the GAMP 5 approach, from requirements to periodic review
- Audit trails, access control and e-signatures aligned with 21 CFR Part 11 and EU GMP Annex 11
- Separate networks for production, laboratories and offices
- Backup and recovery tested on a schedule, with records for inspectors
Standards that apply
- EU GMP Annex 11
- 21 CFR Part 11
- GAMP 5
- ISO/IEC 27001
- HIPAA
- GDPR
Services
The services they use most
- Managed IT ServicesFull IT outsourcing: user support, workstations, servers and networks.
- CybersecurityRisk assessment, threat protection, monitoring and incident response.
- Enterprise ApplicationsImplementation and support of ERP, BAS/1C and business systems.
- Compliance & IT GovernanceIT audits, security controls and regulatory compliance (GMP, ISO, etc.).
Industries