MCD CONSULTING SERVICES, INC

Validation & Automation Expertise

MCD Consulting Services, Inc. specializes in validation and regulatory compliance, computer systems validation, and process automation. Our methodology and services are designed to support pharmaceutical, medical device, and biotechnology companies in meeting stringent industry standards.

Process Validation Services

We support the full lifecycle of process validation to ensure your manufacturing processes consistently produce products meeting predetermined specifications.

Process Validation Lifecycle

Execution of Stage 1–3 activities, from process design to continued process verification.

Process Characterization & Qualification

Development of risk‑based protocols and execution of IQ, OQ, PQ and PPQ studies.

Sampling & Monitoring

Design of statistically valid sampling plans and in‑process monitoring strategies.

Protocol Development & Execution

Preparation of validation master plans, test scripts and reports in line with cGMP and regulatory expectations.

Continuous Improvement

Analysis of performance data, root‑cause investigations and corrective actions to optimize process capability.

Computer Systems Validation (CSV)

MCD offers an exceptional level of experience in Computer System Validation (CSV), including prospective and concurrent validations, 21 CFR Part 11 Gap Analysis and Audits, and Electronic Records/Electronic Signatures assessments.

CSV Lifecycle Management

21 CFR Part 11 & Annex 11 Compliance

Data Integrity & ALCOA+

Testing & Documentation

Gap Assessments & Remediation

Security & Periodic Reviews

Cleaning Validation Solutions

We design and execute cleaning validation programs to prevent cross‑contamination and ensure product quality across multi‑use equipment.

Acceptance Criteria & Limits

Calculation of Maximum Allowable Carryover (MACO) values and definition of residue limits.

Method Development

Validation of analytical methods for detecting active ingredients, cleaning agents and degradation products.

Multi‑Product Strategies

Risk‑based approaches for shared manufacturing lines and campaign production.

Change Control & Documentation

Maintenance of validated state through change management, deviation management and ongoing review.

MCD Consulting Services, Inc. personnel have extensive validation experience in facilities, utilities, equipment, and systems

Facilities validation ensures compliance with regulatory standards and operational efficiency

Utilities validation covers critical support systems essential for pharmaceutical and biotech production

Equipment and Systems Validation

Validation of equipment and systems guarantees reliable performance and quality assurance

Equipment Qualification by Industry

Facilities & Utilities

Lyophilizers
Tray Washers
Tunnels
Tray Loaders
Fillers
Ovens
Equipment, Computer, and Process Validation

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Equipment Qualification by Industry

Our expertise spans a wide range of production equipment, with tailored qualification protocols for each sector.

Solid Dosage

Blenders

Tablet Presses

Granulators

Coaters

Dust Collectors

Sterile / Parenteral

Lyophilizers

Fillers

Autoclaves

Cappers

Laminar Flow

CIP/SIP

Biotechnology / Biosimilars

Reactors

Chromatography

Filtration

Tanks

Pat

Packaging

Fillers

Wrappers

Labelers

Cartoners

Vision Systems

Palletizers

Process Automation

We design and validate control systems to automate manufacturing processes while maintaining compliance and efficiency.

Our multidisciplinary team provides end‑to‑end support—from strategy and planning to execution and optimization—ensuring your facilities, utilities and systems are compliant, efficient and ready for inspection. We combine technical depth with regulatory insight to deliver solutions that stand up to audits and accelerate time‑to‑market.

Why Work With MCD Consulting Services?