IT Compliance and Validation

Background

The life sciences sector, by its nature, is a highly regulated working environment. The Industry has experienced a dramatic increase in the level of regulation with an expansion of the range of various good practice (GxP) regulations in addition to the introduction of new privacy (Data Protection Act, HIPAA) and fiscal (SOX) regulations. These regulations have implications for all IT systems, both transactional and informational, in addition to the corresponding IT work practices for the management of the systems life cycle.

Key current regulatory systems challenges for Life Science IT Compliance:

Consistent, enterprise-wide IT compliance management and execution strategy that incorporates outsourced IT activities
Business demand for the quick adoption of new technology standards and world-class operational performance to improve competitiveness and assist in the early introduction of new products.
Staff reductions arising from global downsizing of pharmaceutical companies.

However, this does not have to be the case. Working with Torque Management, CIOs and IT Compliance Directors have an opportunity to review their compliance strategy, methodologies, and associated costs, adopt new methodologies, processes and tools that will radically alter their ability to manage and monitor IT Compliance.

Torque Management IT compliance services

Our compliance services address the key issues for effective and efficient IT Compliance:

Strategy for compliance
Cost of compliance
Compliance resource management
Effectiveness and Efficiency of compliance processes
Compliance Risk Assessment and Risk Management

Torque Management has established a world-class compliance services team to assist Organisations through all phases of IT compliance. Our understanding of the existing regulatory requirements means that our Compliance services have been developed not only to satisfy today’s environment but to anticipate the emerging needs in the marketplace. Using our comprehensive processes and tools, we bring a low risk approach to IT compliance across the full compliance continuum, guiding organisations through all stages of IT compliance and IT Compliance risk assessment and management:

IT Governance for compliance
IT Compliance performance assessment: - this service is available at enterprise level and business unit level
Corporate IT Compliance Policy Development
Delivery and implementation of an online, real-time validated IT management system incorporating quality documentation, IT process maps, Key indicators, SOPS, self assurance / audit activity
System(s) Compliance and validation services for: cGAxP, security, Data Protection, HIPAA, CobiT, SOX, ISO XXX etc.
Qualification and Validation services (MVP - DQ - IQ - OQ - PQ)
IT Security Review (ensuring data integrity through the LAN, WAN and associated processes)
Independent Vendor Audit services
Quality Assurance / oversight services
Development and delivery of an online, real-time validated IT management system incorporating quality documentation, IT process maps, Key indicators, SOPS, self assurance / audit activity
Training for validation
Customised consulting

Our solutions provide methodologies that result in accelerated delivery, minimising the cost of compliance without compromising quality.

Working with Torque Management our clients develop greater confidence in IT infrastructure and applications compliance, such that the integrity of systems and data is achieved, demonstrable and maintainable.

Interested?

For further information on our IT Compliance services Contact us

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