Outsourced Life Science Services for Contract Manufacturing, Labs, and Research Organizations
Most life sciences companies strategically utilize outsourcing of many functions to contract manufacturers, testing laboratories, and research organizations. Outsourcing allows life science companies to concentrate on their core competencies and at the same time reduce labor and overhead costs by providing access to expertise and facilities that don't exist in-house.
Regulatory Requirements
When a company transfers a function to an outsourced organization, they become subject to the same regulatory requirements as its client. Outsourced organizations share with their customers the burden of compliance including the need to meet the demands GxPs, 21 CFR Part 11 and other regulations.
Life Science Outsourced Organization's Challenges
An outsourced organization shares the sponsoring company's ultimate goal, which is the successful commercialization of a safe, reliable, and effective product. To achieve this goal, the outsourcing organization must address many challenges, including:
- Accountability: Extensive outsourcing in the life sciences industry and have created a growing focus and emphasis on the accountability of outsourcing organizations. Life science companies are expecting more and more that outsourcing companies clearly demonstrate the appropriate management of their intellectual property, the reduction of risk to their projects by rigorous adherence to regulations, as well as accountability and transparency to ensure the responsible use of their monies. InfoStrength Smart Enterprise Suite enables the outsourcing organization the ability to partner on a 24X7 basis with client with all the controls and accountability clients are growing to expect.
- Inefficient Systems: Companies with multiple facilities typically have independent, hybrid systems and even paper-based systems in place. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections. Infostrength Smart Enterprise Suite is designed to incorporate the whole company at the enterprise level, while maintaining each division’s independent workflow.
- Disconnected Processes: Processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to customer complaint, CAPA and training, is likely to cause delays in change implementation.
- High Cost of Validation: As required by 21 CFR Part 11, a secure environment must be maintained to properly manage critical electronic information and electronic signatures and validation efforts may be required. As a result, validation services can double or even triple the cost of a software system. Infostrength Smart Enterprise Suite is designed specifically for the outsourced life science industry, and our staff has developed the test scripts necessary to ease system validation burdens. Because InfoStrength Smart Enterprise Suite is usable right out of the box, and configurations are executed at the server level, the need for extensive validation efforts across the enterprise is less than comparative systems in the market.
Key benefits realized by InfoStrength customers include
- Faster time-to-market:
Accelerate production and release cycle by gaining real-time visibility into the quality and document management process and its key performance metrics.
- Reduced Costs:
Lower the cost of regulatory compliance and the cost of poor quality by building operational efficiencies in quality systems.
- Improved Processes:
Proactively identify, track and resolve quality and compliance issues by creating a transparent environment where decisions are based on hard facts and metrics.
- Reduced Noncompliance Risk:
Adopt an integrated systems-oriented approach that has compliance built into each system to adhere to regulations and standards such as FDA 21 CFR Part 11.
What Solutions Are You Looking For?
Learn how InfoStrength Smart Enterprise Suite provides solutions for the Outsourced Life Science industry.