Validation (IQ/OQ/PQ) and CSV

Validation — IQ/OQ/PQ

We help medical device companies plan, execute, and document validation activities that demonstrate your processes, equipment, and computer systems perform consistently and as intended — meeting the requirements of FDA 21 CFR Part 820, ISO 13485, and GAMP 5 guidelines.

What We Offer

Process & Equipment Validation (IQ/OQ/PQ)

• Validation Master Planning — We develop Validation Master Plans (VMPs) that define your overall validation strategy, scope, responsibilities, risk-based prioritization, and documentation standards across your facility and product lines.
• Installation Qualification (IQ) — We verify and document that equipment and systems are installed correctly, in accordance with manufacturer specifications, approved drawings, and facility requirements.
• Operational Qualification (OQ) — We establish and execute test protocols confirming that equipment and processes operate within defined limits and perform as intended under anticipated operating conditions.
• Performance Qualification (PQ) — We demonstrate through documented evidence that processes and equipment consistently produce results meeting predetermined acceptance criteria under real-world production conditions.
• Process Validation — We support validation of manufacturing processes — including sterilization, molding, welding, coating, assembly, and packaging — using prospective, concurrent, or retrospective approaches as appropriate.
• Cleaning & Sterilization Validation — We design and execute validation protocols for cleaning processes and sterilization methods (EO, gamma, steam, e-beam) to meet FDA and ISO 11135/11137 requirements.
• Test Method Validation — We validate analytical and inspection methods to ensure your measurement systems are accurate, repeatable, and suitable for their intended use.

Computer System Validation (CSV)

• CSV Strategy & Planning — We develop CSV plans aligned with GAMP 5 risk-based approaches and FDA 21 CFR Part 11, categorizing systems by complexity and criticality to focus validation effort where it matters most.
• Software & System Validation — We validate computerized systems used in manufacturing, quality, and laboratory environments — including ERP, MES, LIMS, eQMS, and other GxP-critical platforms — with complete documentation packages.
• 21 CFR Part 11 Compliance — We assess and remediate electronic records and electronic signature (ERES) compliance gaps, ensuring your computerized systems meet FDA audit trail, access control, and data integrity requirements.
• Data Integrity Assessments — We evaluate your systems and processes against ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) to identify and address data integrity vulnerabilities before they become regulatory findings.
• Validation of Off-the-Shelf (OTS) Software — We apply risk-based validation approaches for commercial off-the-shelf software, developing User Requirement Specifications (URS), traceability matrices, and test scripts appropriate to the system's GxP impact.
• Revalidation & Change Control Support — We manage validation impact assessments and revalidation activities triggered by equipment changes, software upgrades, facility moves, or process modifications.

Why It Matters

Validation is a cornerstone of FDA and ISO 13485 compliance — and a frequent focus of inspections and audits. Inadequate validation documentation is a leading cause of 483 observations, Warning Letters, and product quality failures. A well-executed validation program not only satisfies regulators — it reduces process variability, prevents costly deviations, and gives your organization confidence in the quality of every product that leaves your facility.

Who We Serve

We support medical device manufacturers, contract manufacturers, and laboratory operations that need experienced validation expertise — whether launching a new process, qualifying new equipment, implementing a new software system, or remediating existing validation gaps.