IT Audit and Computer Validation Services

Our IT audit professionals have many years of IT control and audit experience which is complemented by professional accreditations, such as Certified Information Systems Auditor (CISA), they can help protect your organization’s information systems, ensure compliance with regulatory requirements and provide insights to leverage IT controls to reduce costs and gain competitive advantage.

Through our IT Audit Service, GURUS can assist customers with a full spectrum of IT assurance services, including technical, operational and security audits. Areas of review includes:

• Internal/external information systems audits
• Internet and firewall audits
• Network and data security
• Computer security
• Information systems policies and procedures
• Disaster recovery and business continuity planning
• IT audits

GURUS also provides Computer Systems Validation services for pharmaceutical and medical device multinational companies. We employ proven methodologies and best practices around quality and project management, with an experienced staff that has developed and refined these practices over many years via complex projects.

We provide technology-based services pertaining to international regulatory compliance for regulatory agencies such as FDA. Services include validation and 21 CFR Part 11 gap analysis, mitigation / redeployment / remediation, master and system specific planning, training & SOP development, as well as archival, storage and retrieval solutions for current and legacy software environments. The detailed services include:

• Validation to GLP, GCP, GMP standards
• Gap Analysis and Risk Assessment
• Development of Validation Documentation Suites including Validation Master Plan, URS and FRS Traceability Matrix, Policies, SOPs, Work Instructions
• Validation Protocols & Reports (IQ,OQ, PQ)
• Change Management and maintaining a continuous validated state
• Rollout of validated applications to additional sites