"[21 CFR Consulting, Project Manager] put together a comprehensive
training program that was concise and efficient. She managed to
summarize a convoluted training program that typically took 3 days of
training into a 4-hour training class without losing any of the key
points. She has a capacity for making something that is complex,
understandable to the new user. We were very impressed with her skills
at both sites.”
-QA Manager, Biotechnology Company
"21 CFR Consulting have been of tremendous value for Part 11 compliance
and computer systems validation [gap assessment]. Their project
management skills kept our project on track by managing various tasks
throughout the system's development lifecycle. We compliment the efforts
provided by 21 CFR CONSULTING, since not only did they execute an
enormous amount of Test Protocols within a very short time frame, but
also helped in the areas of vendor management with data migration and
incident reporting issues, addressed the areas of concerns with Part 11
systems limitations, and worked closely with the system administrators
to help reengineer business processes. We will consider using 21 CFR
Consulting again for future projects and for consultation”
-QA Associate Director, Biotechnology Company
"[21 CFR Consulting, Project Manager] was indispensable during our
validation. We were having a whole myriad of issues: hardware, software,
user inexperience, insufficient knowledge of 21 CFR validation
requirements, etc. They competently addressed and resolved each issue,
and were a major component in the success of our validation".
-QA Manager, Biotechnology Company |
