Life Sciences Executive Webinar Series – “Mastering Compliance and Innovation”

Merit Solutions and OnShore Technology Group are excited to launch a new monthly Life Sciences Executive Webinar Series titled "Mastering Compliance and Innovation”. This series will identify ways Life Sciences organizations can excel beyond the basics and leverage innovative technologies to achieve continuous improvement and global success.

(more…)

Continue Reading

Are You Still Doing What You Say You Are Doing?

A very common audit observation is not following procedures. 23% of quality related warning letters issued by the FDA in 2013 were for document controls. The lion’s share of these issues involved the use of documents that do not follow the process. An auditor may notice a gap while reviewing document controls, reviewing executed records, during direct observation of your process or through questioning of operators. They may also probe multiple operators to establish consistency.

Some managers may have a false sense of confidence in thinking that “We’re O.K. We have a procedure for that.” Yes you can certainly be cited for having no procedure at all. But you have to look at the adequacy of the procedures to the purpose and scope. The CFR requirements are specific. Documents should be clear and easy to follow. Changes have to be documented, reviewed and approved. Communication of a change and evidence of training must be documented.

(more…)

Continue Reading

End of content

No more pages to load