Pharmaceutical
The pharmaceutical industry is constantly being challenged to meet the rising standards of quality and to comply with rigorous regulatory requirements. Regulatory requirements include FDA GxPs and reporting mandates, international drug safety standards, and cross-industry compliance requirements stipulated by laws such as the Sarbanes Oxley Act. Compliance is evolving from an isolated departmental initiative to an enterprise level Risk Management challenge.
InfoStrength offers an integrated solution for successfully meeting regulatory requirements while simultaneously lowering associated costs that can otherwise be substantial.
InfoStrength’s Smart Enterprise Suite is being used in the life science industry for supporting key processes and requirements for compliance at various stages.
Pre-Market Stage: FDA conducts comprehensive evaluation of Investigational Drug Applications (IND) and New Drug Application (NDA) based on the data and documentation provided for drug safety and efficacy, risk management, and GxP compliance issues for clinical, laboratory, manufacturing procedures. InfoStrength’s Smart Enterprise Suite allow customers to reduce their development risks and accelerate approval cycles by enabling them to manage their R&D processes and commercialization projects, capture and track potential safety issues, assess risks and implement corrective actions, and identify potential quality issues.
Drug Manufacturing: 21CFR Part 210 and 211 define the ...minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess and ...failure to comply, shall be subject to regulatory action. InfoStrength’s Smart Enterprise Suite reduces GxP non-compliance risks by creating a transparent environment for proactively identifying, tracking and resolving quality issues.
Risk Management: InfoStrength’s Smart Enterprise Suite provides an integrated and flexible framework for documenting and assessing risks, defining controls, managing audits, identifying issues and implementing recommendations and remediation plans.
Pharmaceutical Challenges
For a Pharmaceutical company developing a drug, 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: Pharmaceutical 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 drugs 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 pharmaceutical 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 pharmaceutical 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 pharmaceutical 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 Pharmaceutical industry.