Open Text Solutions for Pharmaceutical & Life Sciences

Helping you achieve compliant management of all electronic records and documents

Pharmaceutical and life sciences companies operate in a highly regulated environment with long product lifecycles. Their operations are both data and document-intensive. Pharmaceutical product development can take up to 15 years and $1 billion or more per product. Recent demands for increased public accountability against a trend of fewer new products and expiring patents are threatening traditional profitability and revenue growth. Life sciences departments must share key information with team members and make the best decisions possible based on all relevant information, while complying with government regulations such as the FDA's 21 CFR Part 11 and conforming to industry standards such as GAMP4.

Open Text solutions for the Pharmaceutical and Life Sciences industries support critical processes where compliant management of all paper and electronic records and documents is essential. We recognize that your processes range from informal research collaborations to formal procedures like SOP review and approval, and that these processes may be limited to single departments, span your enterprise or even include alliance partners, contractors and consultants. Users can use a range of interfaces ranging from email clients, Web browsers, as well as office and specialty applications, allowing them to work in the environment that is most natural to them.

Open Text solutions for Pharmaceutical and Life Sciences are based on a framework providing the right task and resource support for the processes in the industry's value chain.

Select your solution in the Value Chain below

(Background on Value Chains)

	Suppliers, Partners, & Regulatory Agencies	Research	Development	Operations & Distribution	Sales & Marketing	Customers, Channels & Regulatory Agencies
		Product Value Discovering and developing competitive products with maximum efficacy and minimal side effects through coordinated activities in the laboratory and clinic that support compelling regulatory submissions
		Research & Development > Drug Discovery > Clinical Trial Management > Collaborative Submissions >
			Product Quality Ensuring consistent, verifiable product quality depends on carefully implemented and maintained procedures that are consistently applied by fully trained operators in each facility, with overall, company-wide oversight and coordination
			Compliant Manufacturing > Policies & Procedures > Program Management >
				Value Realization Facing the challenge of limited periods of exclusive market access for new products require rapid launches and a concerted drive to achieve peak sales of new products in all major markets
				Contract Management > Brand Management > Sales Collateral Management > Customer Information >
				Safety & Surveillance Addressing increased regulatory oversight and public scrutiny require early identification and corrective response to any issues that impact the safety of products delivered to patients and consumers
				CAPA, Incident & Complaint Management >

Enterprise Support

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  Compliance & Governance
  • Corporate Governance
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  Corporate Services
  • Environment, Health & Safety
  • Facilities, Fleet & Equipment Management
  • Legal
  • Performance Monitoring
  • Quality Management
  • Travel Management
• 

  Customer Services
  • Cross-selling
  • Field Maintenance
  • Issue Resolution
  • Knowledge Transfer
  • Services Delivery
• 

  Finance
  • Accounts Payable
  • Accounts Receivable
  • Financial Management
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  Human Resources
  • Benefits Administration
  • Communications
  • Workforce Management
• 

  Information Systems & Technology
  • Information Lifecycle Management
  • IT Consolidation
  • IT Operations
  • SAP Support
• 

  Marketing
  • Brand Asset Management
  • Product Marketing
  • Public Relations
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  Sales
  • Customer Relationship Management
  • Sales Operations
  • Sales Order Management