That you can give individual business units within your enterprise-wide system the flexibility to optimize their local processes with the help of filtering technology?
The FDA recently finalized a guidance to help pharmaceutical companies operate modern quality systems that are fully compliant with CGMPs. The guidance identifies seven concepts critical for modern quality systems.
Especially for Pharmaceuticals
It is not uncommon for a single product to generate hundreds of pages of documentation to demonstrate design control compliance. Let’s discuss how you can reduce your documentation burden.
By Matthew M. Lowe
Especially for Medical Devices
21 CFR Part 601 is the basis for CBER’s authority to grant accelerated vaccine approval. Here are five things you need to know about the program.
Especially for Blood / Biologics
How to Solve the Top Five Quality Audit Challenges
When the American Red Cross was hit with a $4.2 million fine last year, it was the culmination of more than a decade of blood-safety violations that stemmed from a poor quality system. Among other things, the FDA found shortcomings in the areas of quality assurance and inventory management, and issues pertaining to donor screening and blood component manufacturing. This kind of systemic problem is just what quality audit is supposed to prevent.
Under GxP principles, quality audit should be conducted periodically as a tool for evaluating the effectiveness of the total quality system. It's not clear to what extent the Red Cross has been performing quality audits. But it’s fair to say that for most life science organizations, quality audits can be daunting. Here are some of the most common challenges pertaining to quality audit and some tips on solving them.
1. Inefficient System for Planning and Scheduling. For audit to be effective, it must be conducted on an on-going basis. And this can be difficult for companies that rely on a paper-based or a partially electronic system. Planning and scheduling would require multiple meetings or conference calls of auditors, auditees, and others involved. Follow-up work would entail uncoordinated phone calls, e-mail, and personal reminders. Scheduling of audit-related tasks would depend on someone remembering to send assignments at certain dates.
Study: Regulated Manufacturers Using Technology-Based Approach to Compliance Gain Competitive Advantage
A recent survey of more than 340 regulated manufacturers throughout the world shows that those adopting an integrated, technology-based approach to compliance and traceability are 65 percent more likely to achieve “Best in Class” status and attain a competitive advantage.
The study titled “Compliance and Traceability in Regulated Industries: Benchmark Report” was conducted by the Aberdeen Group, a leading provider of fact-based research and market intelligence, and co-sponsored by MasterControl Inc. The Aberdeen Group surveyed manufacturers in pharmaceutical, medical device, food and beverage, chemical, aerospace, automotive, and other industries. Survey participants included Pfizer, Roche, and Wyeth.
The study, released in January, found that compliance and traceability needs of manufacturers stem from FDA and EU regulations (86 percent for best-in-class manufacturers, 72 percent for all others), and customer requirements, such as ISO standards (72 percent and 78 percent, respectively). Most regulated manufacturers still view traceability and compliance as a necessary business process. But at the same time, they utilize compliance and traceability as a competitive advantage (50 percent and 40 percent, respectively). Read more.
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