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Policies & Procedures Solutions for Life Sciences.

Operating tempo for companies in the life sciences industry, including pharmaceutical manufacturers (ethical, generic, specialty, OTC), biotechnology, distributors, and medical devices continues to increase. Advances in science are revolutionizing the way the industry operates, increased competition across all segments is fierce and increased complexity in R&D processes and the inherent risks that come with new product development are all impacting the way the life sciences industry operates. Compounding these challenges is the increasingly active role of regulatory agencies across all stages of the product lifecycle.

While technology certainly plays a role in the dynamic life sciences business environment, it’s unrealistic to suggest that automation technologies such as ERP, RFID, supply chain management or customer relationship management will pave the way to prosperity for all companies. Contextware recognizes that your proprietary business processes, the essence of the way you manage your company and operations, are as important to your success as the systems in place to help automate and execute them.

Increased attention to procedures and compliance plays an important role in the way that public and private businesses, government and non-profits are managing their businesses. Driven to a large degree by evolving and increasingly complex regulations, companies and organizations are forced to spend a significant amount of time and money on attorneys, consultants, auditors and software to satisfy these growing requirements.

With our solutions, you can:

Precisely document relevant activities.
The software is designed to allow business users and subject matter experts to easily document procedures and business processes. Users are also prompted to consider the business information relevant to what they have written.

Audit and monitor.
Contextware's digital audit trail precisely tracks user activity, so auditing can take place at the user/task level — documenting regulatory compliance in detail. Because the software is web based, it is easy for your auditors to review processes and employee interaction with them remotely.

Share compliance intellectual assets and activities across
the enterprise.

The biggest problem with buying a software product to support a compliance requirement is that it only supports that specific compliance requirement. Architected to easily scale, you can incorporate compliance-relevant information into other processes then share with users across departments.

Make your business or
organization work better.

As you document activities, monitor and audit them, you get a keen sense of what works and what doesn't, so you can continually refine and improve critical business activities.

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