Valicom is pleased to offer the following services.
Computer System Validation | 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
Development of Training Programs | General GxP Training | Process-specific Training
Supplier Audits | Internal Audits | Hosting Audits and Inspections
Marketing Application Development (NDA, ANDA, BLA, 510(k), etc.) | Device Listing | CE Marking
Fulfillment of QC/QA/Regulatory/Compliance Management Roles | Laboratory Operations
We’ve offered services in environments governed by GMP, GLP, GCP, and QSRs, and for the biotech, pharma, device, and diagnostic industries.