Services
We offer a variety of narrowly tailored IT services for your organization’s needs, some of which include the following:
- Deployment of Accounts and Devices
- Troubleshooting
- Reviewing Business Processes
- Design IT Solutions and Networks
- Network Documentation, and creation of SOPs
- Risk Mitigation
- Cybersecurity
- Developing IT and Organization Strategy
- GxP and GMP Compliance
We are here to help you every step of the way, whether it be the implementation of new systems, or organization of ongoing workflow systems!
Validation and Qualification Services
– Computerized System Validation (CSV) – GAMP 5 aligned
– Equipment Qualification (IQ/OQ/PQ)
– Facilities & Utilities Validation (cleanrooms, controlled environments)
– Packaging, Serialization & Aggregation Validation
– Analytical & Manufacturing Equipment Validation
– Data Integrity Assessments & Remediation
Computerized Systems & Digital Compliance
– ERP Validation (Oracle, SAP, cloud SaaS platforms)
– MES / EBR / eLogbook Systems
– LIMS, QMS, Serialization & Supply Chain Integrations
– 21 CFR Part 11 & EU Annex 11 Compliance
– Assessments for Data Integrity and Process Mapping
– Audit Trail, Security & Access Control Validation
– Cloud & Vendor-Managed Release Impact Assessments
Lifecycle & Inspection Readiness
– Validation Master Plans (VMP)
– Risk Assessments (SIA / SICE / CSA-aligned approaches)
– Change Control & Release Impact Assessments
– Deviation, CAPA & Remediation Support
– Regulatory Inspection & Audit Readiness (FDA, MHRA, EU)