When 21 CFR Part 11 was introduced in 1997, it created in equal measure - confusion and consultants. Fourteen years on, the confusion has largely disappeared and while regulation remains under review the chances of wholesale changes are highly unlikely. The cottage industry of consultants remains though, eager to serve for three months and leave a pile of validation protocols in their wake. While there are many competent hardworking consultants out there, there are many yet, who by virtue of their profession, have never sat in front of FDA or EMEA, have never had to defend last weeks, last month, or last years validation package.
Sidus Bio Data offers a different approach. Imagine bringing a new ERP system on board without having to purchase a single server, and without having a team of validation consultants in house. Sidus BioData can not only host your system and its data, but also prepare and execute your compliance deliverables all the way through PQ/UAT authoring. Your validated servers will be secure, compliant and managed by one the most experienced Regulated IT Infrastructure teams in the industry. Plug and play compliance is only a phone call away.
For more information about how you can take advantage of Sidus BioData regulated hosting and compliance services please Contact Us
By: Lisa Ackerson