We are the Definitive Experts on Pharmaceutical Quality Metrics
Compliance Architects® is the definitive expert in the field for pharmaceutical quality metrics. We have developed and implemented cloud-based enterprise metrics reporting systems, including process development, definitional alignment and formal reporting frameworks. Jack Garvey, Founder of Compliance Architects®, has moderated multiple industry conference panel sessions on the topic, and has written multiple articles on the topic. We know metrics, and how to develop the systems and practices to cost-effectively implement, report and deliver value from the efforts.
The Metrics Reporting Requirements are Coming Soon!
The requirement for all pharmaceutical companies (brand, generic, contract manufacturers, etc.) to collect, aggregate, and report on their internal quality metrics is FAST approaching. There are many activities, processes, and responsibilities that each and every pharmaceutical company (OTC, Rx, and Combo Products) will need to implement soon to be ready for FDA's looming reporting requirements. And, regardless of whether these requirements change from the original proposal, they will come in some form, and, companies can benefit now from the information good metrics programs provide.
Confirmed by All Major Industry Organizations
In addition to the FDA issuance of a formal guidance, all major industry organizations have formally endorsed the movement to pharmaceutical metrics, and are working in concert, and with FDA, to finalize plans. Industry groups include: PDA, ISPE, PhRMA, GPhA, PBOA, and CHPA, along with Xavier Health.
Success Requires Integrated Reporting Approaches
The reporting requirements for pharmaceutical quality metrics will require companies to make significant changes to or adopt new processes, procedures, personnel and IT / IS tools. Implementing a reporting framework that produces reliable, useful data requires a distinct set of skills, knowledge, experience and program management capabilities. Activities such as data aggregation, data definitions, reporting timeframes, source data validation, etc. are complex and not within the realm of today's typical quality staff.
Your company will need to consider the following: computer based systems; standard and consistent definitions; new procedures data quality standards; new roles and responsibilities for collection, aggregation and reporting of metrics; submission development and approval; and FDA inspection support surrounding metrics reporting.