Focused on enabling the life sciences since 2007
Headquartered in Orange County California, Compliance Management Systems, Inc. works around the globe. Our firm specializes in all GxP compliance assurance matters, from assessments and audits through to small, medium and large remediation efforts. Whether you’re a small one drug pharmaceutical company, big pharma, CxO, or medical device manufacturer, we will not only assess your maturity, but we’ll also support your growth under the increased regulatory focus on all aspects of data integrity. We bring extensive experience and professionalism to every project and customize our support to your individual needs and concerns.
Our consultants have been practicing for decades and started during the .com internet boom of the late 90s. We’re on the pulse of modern technology and cloud, and have monitored their evolution to inform our own compliance approaches—all to give you exceptional guidance that will last for years to come.
Get in touch with us to set up a consultation, or use the contact form at the bottom of this page to inquire whether our services are right for you.
Contact
➤ LOCATION
1300 S Bristol St., Suite 222
Santa Ana CA 92704
☎ CONTACT
info@qmscore.com
CSA/CSV Program Subscription
CSV Program Subscription
The CMS CSV subscription model is the outsourcing of CSA and GAMP 5 SE aligned CSV activity, in collaboration with the client validation team (system owner, process owner and QA), and includes:
Establishing CSV program
Updating system inventory
System Risk Assessment
Remediation planning
CSV Project Services at contract pricing, to support CSV remediation activity where needed and for new systems and major changes to existing systems
Maintaining the validated state of systems through CMS CSV SME engagement in:
Maintaining the CSV Program, including updates based on regulatory changes / process improvements
Maintaining System Inventory of all computerized systems
Providing process clarification and guidance to QA and IT on CSA CSV Procedures
CSV vendor management (optional)
CSV periodic review
Supporting change control for minor changes w/limited CSV work (includes CSV impact assessment, CSV deliverable revision, and lower risk CSA testing)
Supporting change control for major changes with contract pricing for CSV Project Services, where needed
Subscription Supplier Management
Subscription supplier management is a highly recommended service that supports the CSA/CSV risk based approach. Our ASQ Certified Quality Auditors (CQA) have decades of experience assessing both the vendor QMS and the life cycle documentation for specific versions in use or to be used. This documented evidence is a key input for system risk management.
“We must all obey the great law of change. It is the most powerful law of nature.”
Let's Chat.
Use the form below to contact us regarding your enquiry. Please be as detailed as possible. Include your industry along with any specific document requests. To help us best service your enquiry, we recommend that you first describe the issue you’re having before telling us what you want to achieve. You may also email us to make an appointment.
For job opportunities, please email us your resume. We’re always looking for new and exceptional talent to lead the firm into uncharted fields of practice.