Health & Life Sciences With human lives affected by inadequate information, products, and services, total quality control is absolutely essential for health and life sciences organisations. Yet commercial demands dictate greater efficiencies and productivity for the provision of health services. For pharmaceuticals and bio-techs, reducing time-to-market for new product development is crucial for competitive advantage. Success for health and life sciences organisations lies in managing this balance.
Throughout these organisations, different people with various competencies and skills interact through often complex business processes – a complete view of available information and knowledge is essential to support sound decision-making and, of course, responsible governance.
This is a diverse and multi-faceted sector where innovation needs to be supported by ethical business processes. Collaboration in research and development and clinical studies is common. And strong corporate governance, compliance and recordkeeping underpin sound management practice, protecting brand values and business continuity.
By managing the documentation processes of the development of new products, Objective solutions help organisations meet stringent compliance requirements of regulatory bodies such as the US Food & Drug Agency, the Australian Therapeutic Goods Administration and Quality Systems such as ISO 9000.
Our solution connects the business critical information these organisations rely upon with the people who need it, when they need it. With the ability to extend access to this information to business and alliance partners, suppliers or contractors, to support project collaboration for improved outcomes in research and development and the provision of services.
Using Objective, proof of compliance with regulatory standards is inherent in the rules and process of our solution. Complete audit trails, previous versions of documents, previous workflow, approvals and decisions – can be evidenced through Objective.
Objective solutions for Health and Life Sciences provide the following business benefits:
- Delivers a single collaborative environment that secures knowledge
- Supports sound decision-making
- Reduces time to market and enables continual improvements in product development
- Provides automation, streamlining business processes like Quality Assurance
- Supports compliance obligation with stringent international regulatory requirements
- Provides security layers to sensitive project information
- Lowers the non-compliance risk of managing associated documentation i.e. with EN ISO13485:2003
- Effectively manages the configuration of medical devices throughout the manufacturing process
- Supports product development, manufacturing, financial and regulatory processes while providing auditable and secure records
- Promotes flexibility as a quality management solution and an ability to add quality processes as the need arises
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