Validation Services
Validation is a requirement in both the Medical device and the pharmaceutical industry. Validation is the practice of ensuring that a product, process or equipment conforms to defined needs, requirements, or specifications under predefined operating conditions. The purpose of Validation is to ensure that a quality product can be reproduced to a pre-defined standard consistently.
AMCS personnel have a strong background in working in highly regulated areas and therefore we develop all our projects in compliance with the highest standards as required by GAMP and FDA. Hence we have the capability to provide fully validated turnkey projects. We also provide third party Validation services to Industry. We use an integrated life-cycle ‘common sense’ approach to validation. Validation is a key Quality Assurance management system and is something that will deliver positive results throughout the life-cycle of the product.
We pride ourselves on working closely in partnership with the customer to ensure that systems are fully documented and are in compliance with top industry standards as required by the medical device and Pharmaceutical industries.
As part of our validation services we will:
- Evaluate a customers compliance to FDA regulations
- Identify risk factors
- Complete turnkey Validation & Testing services
- Complete and execute project plans to validation objectives
AMCS three main area of expertise are in:
A) Process:
Where we will develop and implement:
- Validation Master Plan
- Validation Project Plan
- Validation Standard Operating Procedures and Detailed Operating Procedures
- Validation Protocols
- Validation Reports and Recommendations
B) Computer systems:
- Control Systems
- Business Systems (e.g. ERP)
- Manufacturing Execution Systems
- Electronic Batch Records
- Database validation
- 21CFR Part 11 assessments
As a leader specialising in regulatory software testing and validation services, AMCS helps clients to ensure that the business systems are functional and that they are delivered in compliance with the highest regulated standards.
- Including Planning
- Protocol Development
- Execution
- Systems Certification
With the use of our in-house software development group we have the ability to:
- Investigate the efficiency of the software
- Completing third party audit of software
- Development of testing scripts to test objectives of the software
- Provide a detailed report for use in validation.
- Complete upgrades and system maintenance
C) Equipment Qualification Solutions:
We can assist our client with, do and/or manage the qualification and commissioning of all your equipment, from the initial vendor selection to the production support. We have significant expertise in the Equipment life cycle and we can complete or manage the process from initiation to completion. Including the implementation and development of the following as part of our lifecycle approach to validation:
- User requirements specifications
- Risk Assessment and Process Failure Mode Effects Analysis (PFMEA)
- Equipment Test Plan
- Project Plan
- Functional Specification
- SW Design Specification
- HW Design Specification
- Equipment Configuration Specification
- Design Drawings
- Bill of Material & Spare Parts
- Traceability matrix
- Calibration Assessment
- Factory Acceptance Testing Protocol
- Site Acceptance Testing Protocol
- Equipment Qualification Protocol
- Equipment Cleaning Validation
- Equipment Inspection Requirements
- Facility/Utility Verification
- Technical Training (Calibration, Maintenance, SW)
- Equipment Inspection Results
- Hazard Evaluation Report
- CE Evaluation/Test
- Technical File Checklist
- Equipment Maintenance Procedure
- Laser Agreement
- Equipment Cleaning Requirements
- User Manual
So why choose AMCS Validation services
AMCS personnel have hands-on validation experience and a keen understanding of industry and its regulation. AMCS's professionals have the ability to offer clients a turnkey approach to validating their manufacturing processes.
AMCS provides validation services in the development and implementation of a validation program that can be an entire manufacturing operation or a specific project tailored to individual equipment, manufacturing process or software applications.
AMCS's Manufacturing Process Validation Services provides effective business risk management, enhanced product quality and an increased knowledge of industry best practice. AMCS will plan, implement and manage risk-based validation projects. We will work with the customer to develop a validation strategy which will be customised to the customer needs.
