Pharmaceutical companies face a growing list of regulations governing everything from production processes to product labeling and instructions, as set forth by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and Japan's Ministry of Health, Labor and Welfare (MHLW). To sell in these markets, companies must keep pace with new format regulations, such as the FDA's 21 CFR Part II governing electronic records and Structured Product Labeling (SPL), requiring labeling in XML format. In addition, they must meet global regulatory standards to ensuring traceability and accountability in production processes and systems.
Veracord combines a core set of skills with technological expertise matched to your business needs to deliver quantifiable value. Veracord's global, practical approach to identifying, designing and implementing technology solutions involves working with clients to analyze existing infrastructure and strategic needs, then carefully engineering solutions that deliver tangible and measurable results.
Veracord Client Support Services
Veracord helps clients develop a standard, consistent and global approach for computerized systems development and validation, including compliance with 21 CFR Part 11. This approach ensure compliance with production systems' validation requirements, including IQOQPQ and enables clients to reduce the risk associated with defending systems integrity to regulatory agencies. Veracord also leads implementation and training programs designed to reduce risk exposure to regulatory noncompliance from global regulatory agencies, including the FDA, EMEU, and others.
Veracord clients are able to outsource their program management to enable their organization to focus on their core mission. Other benefits include reduced pressure from dependencies on internal tools, knowledge and priorities. Veracord project management experts deliver quality services, mitigate risk, plan accurately and ensure effective oversight.
Business Process Services
Veracord helps clients reduce costs and increase revenue by initiating new business processes or refining inefficient processes. Veracord introduces best-practice services including assistance with business case justification. Veracord works with clients to conduct a thorough benefits analysis to determine investment value and expected results.
Business Analysis and Strategy
Veracord helps clients bridge the gap between business issues, corporate vision and goals, and technology. By analyzing strategy, design, specifications and success measurements, Veracord refines project goals and requirements to ensure project success. We also work with clients to manage the impact of new or updated technologies on their organizations.