Compliance & IT Governance
Compliance and IT governance
Ensure that your IT environment meets industry and regulatory requirements, including GMP, ISO and corporate security standards.
Overview
Compliance & IT Governance
Compliance is proof: that systems are controlled, changes are approved, data is intact and risks are known. Without that proof, an audit or an inspection becomes a crisis.
We audit IT against the standards you answer to, close the gaps and set up the governance that keeps the evidence coming: policies, roles, change control and regular reviews.
Standards and technologies
- ISO/IEC 27001
- EU GMP Annex 11
- 21 CFR Part 11
- GAMP 5
- ISO/IEC 20000-1
- COBIT 2019
- SOC 2
- GDPR
What we do
Our compliance and governance services
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IT audits and assessmentsReview of systems, controls and security practices.
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Regulatory complianceSupport for GMP, ISO and industry-specific requirements.
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IT policies and governanceDevelopment and implementation of IT governance frameworks.
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Risk managementIdentification, assessment and mitigation of IT risks.
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Computerized system validationGxP validation by the GAMP 5 approach, from requirements to periodic review.
Approach
How we deliver it
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01
Gap analysis
Your IT checked against the standard, clause by clause.
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02
Remediation plan
Gaps ranked by risk, with owners and deadlines.
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03
Implementation
Policies, procedures, controls and records put in place.
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04
Audit readiness
An internal audit, an evidence pack and support during the external audit.
Benefits
What you get
- Evidence ready before the auditor asks
- Policies people actually follow
- Risks known, owned and tracked
- Systems validated and kept in a validated state
Delivery model
How the work is organized
Gap analyses and audits are fixed-scope projects. Governance and compliance support run as an ongoing service: periodic reviews, change control, training records and preparation for each audit or inspection.
Questions
Questions and answers
Can you prepare us for ISO/IEC 27001 certification?
Yes: gap analysis, the information security management system, policies, risk assessment, internal audit and support during the certification audit.
Do you validate computerized systems for GMP?
Yes. We follow the GAMP 5 approach: requirements, risk assessment, test protocols and reports, then change control and periodic review.
Industries
Where it matters most
More services
One partner for the rest of your IT
- Managed IT ServicesFull IT outsourcing: user support, workstations, servers and networks.
- CybersecurityRisk assessment, threat protection, monitoring and incident response.
- Cloud & InfrastructureCloud solutions, data backup, disaster recovery and high availability.
- Enterprise ApplicationsImplementation and support of ERP, BAS/1C and business systems.
- IT Projects & ModernizationInfrastructure upgrades, migration, automation and integration.
- Web Development & DigitalCorporate websites, e-commerce, web portals, UI/UX, SEO and support.