With the trend away from project-by-project outsourcing toward long-term strategic partnering, CROs and CMOs have much to gain by following their sponsors' best practices. Failure to comply with good clinical practice and good manufacturing practice guidelines could subject your organization to the same regulatory actions as a sponsoring company.
Minimizing the time to market for new drugs is a business imperative for all life sciences companies, regardless of their scope or size. A sound quality and content management platform will help you stand out from your competitors. With a solution implemented by GxP Partners, you're assured:
- less start-up time for projects
- a streamlined document review and approval process with your sponsoring organizations
- compliant electronic capture, storage, and retrieval for central lab and clinical trial data
- compliant reporting of training activities and certifications, including those for highly skilled equipment operators within CMOs that are advancing leading-edge, complex biotech processes
- the ability to provide secure audit trails to regulatory boards
- paperless instrument calibration
- a competitive advantage with your information management practices
As the FDA enforces a risk-based approach to cGMPs and 21 CFR Part 11, pharmaceutical and biotechnology companies need technology solutions that balance the need to innovate with the need to control. With years of experience in life sciences, GxP Partners understands the regulatory pressures in the industry as well as the processes required for efficient product development and manufacturing.
GxP Partners solutions help to foster innovation within your organization while maintaining a primary focus on safety, efficacy, and security. We've made it our business to navigate the requirements for GxP electronic records and signatures based on predicate rules, the nature of the process, and the quality and safety risks. We know how to apply security measures for both high-impact and low-impact records. Plus we know when and how the integrity of your business information can be protected through configuration management, system validation, change control, and security features.