Validation and Compliance Services for Computer/Lab Systems
Validation Services - Computer Systems
Our Services include:
RS Serve provides total validation services to ensure that your Computer Systems are compliant with FDA, GxP, 21 CFR Part 11, Other Governmental regulations and industry standards.
- Validation Strategy and Implementation
- Computer Systems Validation
- Network and Infrastructure Qualification
- Document Management Systems
- Clinical Trials Systems
- Drug Safety Systems
- Quality Management Software (QMS)
- EDC Systems
- CAPA Systems
- Prospective and Retrospective Validation
- Validation Staffing
- Validation Documentation including Validation Master Plan, IQ/OQ/PQ, Traceability Matrix, Summary Reports
- GAP Analysis and Risk Assessments
- Vendor Audits
- Quality Review Services
- Technical Writing
- CSV Training
Validation Services - Laboratory and Equipments
RS Serve provides complete Laboratory and Equipments Validation Services to ensure that your lab systems and equipments meet GLP, GMP and GCP standards along with 21 CFR Part 11 and other industry standards and regulations.
Our Services include:
- Development and Implementation of Validation Master Plans.
- Develop and Execute IQ/OQ/PQ for Laboratory Systems and Equipments.
- Develop Standard Operating Procedures (SOPs) for Administration and Maintenance of equipments related to Computer Systems.
- Conduct GAP Analysis, Risk Assessments and Develop Remediation Plans.
- Evaluation of Current Compliance States.
- Quality Review of Documentation, Protocols and SOPs
- Lab Systems: HPLC's, LCMSMS, Scientific Data base Management System (SDBMS), Bio-analytical LIMS.
Global businesses in regulated industries turn to RS Serve to achieve compliance within an increasingly complex regulatory environment. With a proven track record on global compliance projects, our people help companies keep their systems in a state of validated compliance without losing operational flexibility and productivity. In fact, RS Serve teams are regularly recognized by our customers as having delivered on time, within budget and with energy and commitment.
Our successes from continuing inspections by worldwide regulatory bodies are a testament to the quality and relevance of our approach for compliance for every client. Our compliance services meet your specific needs due to our unique approach.
Comprehensive Risk Assessment/Analysis:
- Root cause analysis
- Functional risk assessment
- Site-applicable risk assessment
Holistic Project Approach:
- Based on global industry regulations such as FDA, EMA etc.
- Full gap analysis
- Protocols, work instructions, and standard operating procedures development
- Effective knowledge transfer
- On-going managed services
Proven Project Life Cycle Expertise:
- Extensive library and repository of industry-related documents, processes and guidelines
- Long history of experience in the life sciences sector
- Basis for continuous compliance throughout project phase(s) and beyond
- Audits and compliance inspections
Other services include: