Computer Systems / IT Audits
At RiverArk we provide expert, impartial assessments that are balanced. These assessments help ensure that strengths are recognized, and weaknesses are addressed. Our team delivers both strategic recommendations and tactical, front-line support through services including programmatic assistance, validation/qualification activities, and computer systems validation.
Besides providing standard computer systems auditing within the tactical service portfolio, our experts also provide a boots on the ground approach towards validation documentation, validation activities and programme assessments. Our team is also very experienced in dealing with ongoing validation and joining existing teams to provide expert input.Â
RiverArk experts have accepted challenges time and again of coming into validation projects that need rescuing. Our experts look at all the work that has already been completed per plan and build a baseline, start incremental improvements and contribute to any additional aspects as required. This method has always been helpful with the clients reaching their compliance goals and operational goals smoothly.Â
Our validation experience spans across instrumental validation within lab environments, equipment validation across manufacturing environment and software validation across all GxP domains.
RiverArk CSV experts have a complete domain experience in helping you build your internal processes for validation and making it stronger for your teams work with. We have helped organisations build processes for the following:
- Change control
- Change Management
- Configuration management
- Electronic signature (certification and policy)
- IT security procedures
- IT Risk Assessments processes
- IT Infrastructure Framework documents
- Retrospective validation
- Patch Management
- Periodic reviews
- Electronic data integrity assessments
Our experts guide compliance to key regulations such as 21 CFR Part 11, EU annexe 11 and any local regulations that may apply.
We strive to deliver pragmatic fit for purpose solutions to our clients to support technology implementation and innovation in the Pharmaceutical and Healthcare sectors.
Computer Science / IT audit offering
- Advice on CSV strategies and requirements
- Statistics and programming in GxP related systems
- Process Audits (SDLC or parts of SDLC and IT support processes)
- Software suppliers
- CSV documentation reviews
- SDLC Design and Implementation
- Computer System Validation (CSV) Audits (Specific system/software or group of systems)
- CSV Vendor Audits (computer systems supplied by third parties e.g. eCRFs, eTMFs, IRT)
- Gap Analyses vs key CSC requirements e.g. 21 CFR 11
- Electronic records/signatures