Our Approach
We listen.
We listen first. We intend to clearly understand the perspectives, needs, and pain-points of your business before suggesting any services to your organization. We do not believe in throw-away, cookie-cutter services. We tailor our services and deliverables to meet the individual needs of each client and each project. As such, we treat each client, each project, and each person in a collaborative and respectful manner to yield the best outcome for your business.
We translate.
We speak the required languages: technology, regulatory, science, and business. We serve as a mediator and interpreter to the stakeholders from the various departments and levels within your organization. This is critical for concise and consistent communication. Our goal is to ensure that all parties remain informed, maintain a clear understanding of the tasks at hand, and remain driven by the benefits that await them at the finish line.
We solve.
This is our passion-- working together with you to find the right solution and seeing you succeed. We get to do this at the junction of technology, science, and quality.
We educate.
We want to share our knowledge and skills with you. We offer a variety of on-site and online training options related to GxP computer systems validation, data integrity and GLP auditing.
Our Services
GxP Computer Systems Validation
Compliant Systems Services, LLC, supports all phases of software validation from vendor selection to system retirement. We are experienced with commercial-off-the-shelf systems (COTS), hosted systems (Saas, PaaS, IaaS, etc.), and bespoke or custom-built systems.
Project Services: New System Validation; Validation of an Existing, Non-Validated System; Upgrade of an Existing Validated System; Multi-Site Validation; Data Migration; System Integrations; System Relocation; System Retirement
Validation Program Services: Validation Program Development, Systems Inventory Development, Data Life Cycle Management and Data Integrity, System Maintenance Programs (Change Control, Configuration Management, Incident Management, and Periodic Review)
GxP Data Integrity & Computer Systems Audits
We provide internal and external audits for data integrity and computer systems validation.
Internal Support Services
Data Integrity Program Audits
End-to-end Process and System Gap Analysis for Data Integrity
Computer System Audits
Computer System Validation Package Audits
Third Party Audits
Vendor audits focused on Data Integrity and Computer Systems Validation practices
GLP Quality Assurance
Aside from software-specific services, we can support preclinical sponsors, Contract Research Organizations (CROs), and analytical labs with a variety of independent GLP Quality Assurance services (U.S. FDA and OECD).
GLP Program Support
GLP Gap Analysis
GLP Program Development
Quality Assurance Unit and SOP Development
GLP Study Support
Study Data and Report Audits
Phase Inspections
Facility Inspections (including Animal & Biosafety Levels 1, 2, and 3)
Mock Inspections
U.S. FDA GLP Inspectional Readiness Assessment
Third Party Audits
Vendor audits to assess GLP compliance
Training
Online or on-location training is available for the following topics:
Organizational Training
Computer Systems Validation
Data Integrity
21 CFR Part 58: Understanding GLP Regulations
21 CFR Part 11: Understanding Part 11 and the Predicate Rules
Good Documentation Practices: Paper and Electronic
Principles of SOP Development
Auditor Training
Auditing for Data Integrity
Basic Computer Systems Validation Auditing
Basic GLP Auditing
GxP Vendor Audits: IT Hosting and Service Providers
GxP Vendor Audits: Software Development Companies
GxP Vendor Audits: GLP Service Providers
Does your company need our services? Contact us today.