Life Science Solutions

Meeting regulations while advancing your capabilities
The Life Sciences industry faces many common challenges in meeting compliance, increasing efficiency, accelerating high quality production and adhering to regulatory requirements.

Complex production processes, globalisation and the requirement to operate faster and leaner are just some of the pressures driving pharmaceutical, clinical research and medical device organisations to implement standardised processes within their organisations.

Designed for the way your company works
iBuild Solutions provides Life Science organisations with solutions for all aspects of quality management, document and drawing management, change control, environmental health and safety, e-batch records, industrial facility management and CAPA solutions including other complex business processes that manage regulated content.

We are aware that success depends on maximising business efficiency while simultaneously complying with regulations. That is why our solutions are designed to uphold the procedural and administrative controls for compliance with regulations such as 21 CFR Part 11, while simultaneously improving the efficiency of collaboration, product development and other business processes.

What we do

• Strategies for Compliance - including document, engineering drawing and records management
• Taxonomy and Metadata Definition
• Process Design for Content Workflow and Lifecycle - including annotation, review and approval processes, change control systems or CAPA solutions
• Regulatory Requirements Definition - to adhere to such standards as FDA 21 CFR part 11, 820 and ISO – EN 13485, cGxP, ISO 9001, 14001
• Deployment of Pre-Configured Solution
• Compliance Solution Implementation
• Dedicated Compliance Expert - provide testing and validation support/services
• Comprehensive Documentation Authoring
• Full Project Management and Coordination