Pharmaceutical Validation Services

Cleaning | Analytical | Process | USP Suitability Studies | Computer System

Validation is the cornerstone of product safety and regulatory compliance in the pharmaceutical industry. At MCS Associates, we deliver science-driven validation services that meet global GMP expectations while supporting operational efficiency and product quality. From protocol design to final report, we ensure every phase is documented, defensible, and audit ready.

Applicable Regulations: FDA (Guide to Inspections: Validation of Cleaning Processes (7/93), EU Annex 15 and Guideline on setting health-based exposure limits, Health Canada Cleaning Validation Guide GUI-0028, PIC/S PI 006 (Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, and Cleaning Validation)

Our cleaning validation services focus on minimizing product cross-contamination and ensuring reproducible cleaning results. Key criteria include:

• MACO (Maximum Allowable Carryover) calculations and worst-case product selection
• Provides procedures for cleaning validation and determination of acceptance criteria based on health-based exposure limits as per EU
• Swab and rinse recovery testing
• Visual inspection limits and cleaning agent compatibility
• Hold time studies and cleaning cycle optimization
• Robust documentation aligned with global expectations

Aligned with ICH Q2(R2) and USP General Chapter <1225>

We validate analytical methods for APIs, excipients, in-process materials, and finished products. Our capabilities include:

• Accuracy, Precision, Specificity, Linearity, Range, LOD, LOQ
• Robustness, repeatability, and system suitability
• Validation for both new and compendial methods
• Stability-indicating method validation for accelerated and long-term stability studies

Following FDA, EMA, ICH Q8–Q11 Guidelines

We support the full process validation lifecycle:

1. Stage 1 – Process Design
   Define QTPP, CPPs, CQAs, and control strategies.
2. Stage 2 – Process Qualification
   Equipment qualification (IQ/OQ/PQ), validation batch execution, protocol/report generation.
3. Stage 3 – Continued Process Verification (CPV)
   Ongoing monitoring of process parameters and product quality trends.

We also support tech transfer, scale-up validation, and statistical process capability analysis.

Even when using USP methods (e.g., General Chapter <61>, <62>, <85>, <621>, <1227> Validation of Microbial Recovery from Pharmacopeial Articles), regulators require confirmation that the method works in your unique matrix and conditions.

We perform:

• Specificity and matrix interference testing.
• System suitability and acceptance criteria confirmation.
• Validation of microbial recovery.
• Documentation to justify method modifications (column changes, flow rate, etc.).

As digital systems become the backbone of pharmaceutical operations, computer system validation (CSV) has never been more critical. At MCS Associates, our CSV consultants help life science organizations validate software, hardware, and digital infrastructure in alignment with GMP, GAMP 5, and ICH Q9/Q10 frameworks.

Whether you are implementing a new LIMS, automating batch records, or modernizing your QMS platform, our team ensures that your computerized systems are fit for intended use, compliant, and inspection-ready—without compromising efficiency.

We approach CSV using a risk-based, lifecycle approach as outlined in GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems. Our methodology aligns with both FDA 21 CFR Part 11 and EU Annex 11 requirements, enabling you to balance regulatory compliance with operational flexibility.

Our GAMP 5-compliant services include:

• System risk assessments and impact classifications
• URS, FS, DS documentation and traceability matrix development
• Installation (IQ), Operational (OQ), and Performance Qualification (PQ) execution
• Vendor audits and supplier assurance programs
• Automated and semi-automated validation testing

We don’t just tick the boxes we build CSV processes that scale with your systems and support data integrity across the full validation lifecycle.

At MCS Associates, we understand that CSV in GMP environments is more than a regulatory checkbox it’s a commitment to product quality, patient safety, and global market access.

We align our validation protocols with:

• ICH Q8–Q11 Quality Guidelines
• 21 CFR Part 11 and Annex 11 electronic records and signatures
• PIC/S Good Practices for Computerized Systems
• ALCOA+ principles for data integrity

Whether you’re validating a laboratory information management system (LIMS), manufacturing execution system (MES), or enterprise resource planning (ERP) software, we ensure data governance, traceability, and regulatory audit readiness are built into your IT infrastructure.

CSV doesn’t live in a silo. That is why we integrate our computer system validation strategies directly into your pharmaceutical quality management system (QMS).

We will help you:

• Embed validation SOPs into your QMS workflows
• Train cross-functional teams on GAMP 5 best practices
• Perform retrospective validation for legacy systems
• Establish a centralized repository for validation deliverables
• Manage system changes through validated change control processes

By treating validation as an ongoing quality process, not a one-time event, we give you greater control, fewer deviations, and continuous regulatory alignment.

Validation is evolving. With the rise of cloud-based platforms, AI/ML integration, and digital transformation in pharma, it’s no longer enough to validate static systems. You need a partner who understands how to validate innovation.

MCS Associates supports CSV for:

• SaaS and IaaS-based systems
• Custom software and in-house builds
• Data migration and digital transformation projects
• AI-assisted diagnostics, digital therapeutics, and eCTD systems

Our approach is not just to validate your technology but to future-proof your compliance.

MCS Associates is your trusted partner for global validation success. We bring:

• Deep expertise in ICH Q8–Q11, Q2(R1), and QRM frameworks
• Proven experience across oral, injectable, biologic, and topical dosage forms
• Global support across North America, EU, and Asia-Pacific markets
• Actionable validation protocols and inspection-ready reports
• On-site, remote, or hybrid validation execution based on client needs

Whether you’re launching a new product, upgrading your facility, or remediating after an audit, MCS Associates provides validation solutions that reduce risk, satisfy regulators, and support long-term quality.

Contact us today to book your next cleaning, analytical, or process validation consultation.

Let’s Build Validation That Works

Whether you’re facing your first validation effort or overhauling enterprise systems across global sites, MCS Associates brings the technical depth, regulatory fluency, and GAMP 5 discipline you need.

Get in touch to learn how our computer system validation services can streamline compliance, mitigate risk, and keep your systems audit-ready from day one.