Biotechnology
The Biotechnology industry includes agricultural, energy, manufacturing and pharmaceutical companies. Biotechnology is involved in many leading edge life science technologies (from cancer drugs to DNA research), and must maintain regulatory compliant software across multiple regulating bodies, including the FDA, the EPA and the USDA.
Regulatory Requirements for Biotechnology Companies
Biotechnology regulatory requirements can fall under many categories, and are often regulated by more than one agency; these include the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Department of Agriculture (USDA). The pharmaceutical segment is covered by a number of regulations, including the FDA's 21 CFR Parts 210-211. Pharmaceutical companies are covered by 21 CFR Part 11 if they maintain electronic-record keeping systems. Many biotech companies also conform to ISO 9000 quality management standards and ISO 14000 environmental management standards. Public companies or those planning to go public or are acquired by public companies are covered by Sarbanes-Oxley Act (SOX) requirements. Having an FDA Compliance Software system to maintain compliance to the variety of regulatory requirements, and adapting to business processes is very important to biotechnology.
Biotech Challenges
For a biotech company developing a drug or therapy, the ultimate goal is to ensure the safety, reliability, and high quality of the product. To achieve this goal, the company must address many challenges, including:
- Inefficient Systems:
Biotech 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.
- Contract Manufacturing:
As more companies rely on Contract Manufacturers to bring their biotechnology products to market, it is important that the systems implemented allow for increased visibility downstream. Infostrength Smart Enterprise Suite provides integration at multiple levels of the process, allowing contract manufacturers to take part in the overall biotechnology industry, without direct access to the main system. This allows the Contract Manufacturers to fill in their pieces of the process, and provide a seamless Quality Management System, from start to finish.
- High Cost of Validation:
As required by 21 CFR Part 11, a secure environment must be maintained, and the biotechnology industry must be validated to maintain electronic signature integrity. 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 biotechnology industry, and our staff has developed the test scripts necessary to ease system validation. Because Infostrength Smart Enterprise Suite is usable right out of the box, and configurations are executed at the server level, the need to extensive validation 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 SES provides solutions for the Biotechnology industry.