Stop Worrying About Your Infrastructure
Are you routinely audited by the regulatory authorities or vendors?
Do you maintain all of the artifacts necessary to show that you have full control of your 21 CFR Part 11 environment?
Are you held hostage by your system admins or your network administrator?
Is your system manager ever able to take a vacation?
Court Square can provide a remote managed service to your present staff to allow them to concentrate on the latest business concerns without worrying about the day to day service delivery duties of the infrastructure management staff.
Having worked with numerous products requiring regulatory oversight we certainly understand the distinct needs of the Life Science industry. We can provide a layer of comfort to the CIO or CFO in an environment where you might not have enough coverage for those critical or legacy applications and still be able to maintain all of the regulatory requirements that your company absolutely requires.
We can also bring in our quality team to review your SOPs and make sure that you will have satisfy any of the regulatory requirements that you may not have even thought about prior to requiring regulatory oversight.
We have a Qualification Toolkit that serves as a starting point to make sure that you can satisfy the auditors based on our numerous years of experience within this industry.