In the pharmaceutical and biotech industry, compliance, accuracy and accountability are critical. Automated workflow provides better internal controls and improved efficiency. Reduce risk and gain a competitive advantage by reducing time to market. In a highly-regulated industry, complete data visibility for both internal stakeholders and external agencies can save countless hours and dollars in regulatory compliance activity.
“Integrify allows us to move a few thousand feet above the day-to-day. The system automates the day-to-day so we can focus on improving service management.”
– Neil Weitz, Director of IT, GlaxoSmithKline
Despite the use of contract manufacturers capital expenditures for new plants and equipment continues to increase sharply. It’s clear that many bio/pharma companies continue to see great value in producing rather than purchasing.
But with the volume of capital expenditure requests being submitted, there is a significant risk of mistakes, delays, non-compliance, and lack of visibility. Given the investment, the cost of these risks can be enormous.
By deploying a compliant and consistent workflow for handling capital expenditure requests, bio/pharma companies can greatly reduce risk while getting a faster return on capital spend.
As bio/pharma companies deal with global expansion, competitive pressure, regulatory changes and changing consumer expectations, it’s critical to get new products to market faster and faster. Unfortunately, the process for creating new products never gets easier.
While product development cycles can’t be shortcut, they can be managed better with workflow management. By building a structured workflow around R&D, Quality, Production, Trials, Packaging, RA and Marketing, bio/pharma companies can reduce risk and ensure compliance while avoiding process bottlenecks. That means products get to market faster.
Bio/Pharma companies are ultimately responsible for ensuring processes are in place for the proper qualification of outside vendors and contractors. When assessing vendors prior to outsourcing operations or selecting material suppliers, workflow management should be incorporated to provide accountability, consistency and mitigate the risk of inconsistent vendor approval processes.
By using a workflow management system, vendors can be consistently screened and properly approved to work with the company. In addition, a separate workflow process can handle contract initiation, where a new relationship or project contract can be routed throughout various levels of hierarchy for review and approval.
Before clinical data, documents or other materials can be disclosed publicly, bio/pharma companies require an extensive approval process involving committees, executives, and multiple staff members.
This process is often handled manually, through multiple different systems or via a cobbled-together system that provides limited efficiency. Approvers have difficulty handling requests and stakeholders have little visibility into milestones. There remains a real risk of improperly approved requests or stakeholders attempting to work around the established process.
A workflow management system streamlines the disclosure approval process by automating request and approval tasks based on preset rules set by the organization. Disclosure approval requests can be entered easily through a portal or from third-party systems.
Requests move from step to step through the approval process without the need for re-entering information. Meanwhile, a complete view of the request status is available to all stakeholders from beginning to end. Integrify ensures full compliance of your Disclosure Approval Process while providing a complete audit trail of each request submitted.
Provide a standardized template for new products to be requested and ensure the proper protocols are followed for taking a new idea to the logical next steps.
Any requests that involve the regulatory process should be standardized and tracked, including Request For Regulatory Services, Request for Regulatory Projects, Request For Regulatory Payment, Pharmacovigilance Tracking, etc.
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