Valicom is pleased to offer the following services:
Validation
Computer System Validation (CSV) and Computer Software Assurance (CSA) | Data Integrity | Lab Equipment Qualification | Manufacturing Equipment Validation | Cleaning Validation | Facility and Utility Validation | Process Validation | Customer-Facing Validation Packages for Vendors
Policy and Procedure Development
Quality Policies | Quality Manuals | Other types of high-level policies (Risk Management, Compliance, Validation, Data Integrity, etc.) | General Procedures (Document Control, Design Control, Vendor Qualification, etc.) | Analytical and Testing Methods | Work Instructions
Quality System Implementation
Training
Development of Training Programs | General GxP Training | Process-Specific Training
Auditing
Supplier Audits | Internal Audits | Hosting Audits and Inspections
Regulatory
Marketing Application Development (NDA, ANDA, BLA, 510(k), etc.) | Device Listing | CE Marking
Staffing
Fulfillment of QC/QA/Regulatory/Compliance Management Roles | Laboratory Operations
We’ve offered services in environments governed by GMP, GLP, GCP, and QSRs in the biotech, pharma, device, and diagnostic industries.
Contact Valicom for efficient, practical support for your GxP compliance and validation needs.