Why Choose Valcomm for Commissioning, Qualification, and Validation (CQV) Activities?
Our extensive experience and our thorough knowledge and understanding of regulatory requirements have assisted many clients in achieving and maintaining compliance. Our projects are regularly audited against the requirements of the regulators. We maintain the flexibility to work within the remit of the client’s commissioning and qualification methodologies and we are committed to providing the latest thinking in a cost-effective and practical manner, fully acknowledging that the right approach can reduce validation costs.
We are experts for the following reasons
Comprehensive Qualification & Validation Experience
Valcomm has extensive experience across industries such as pharmaceuticals, life sciences, manufacturing, and healthcare, providing end-to-end support in commissioning, qualification, and validation activities. Our services range from developing as-built documentation, to executing complete process qualifications for complex manufacturing environments. We utilise methodologies that combine commissioning and qualification to streamline processes and ensure compliance.
Expertise in Regulatory Compliance
Valcomm’s team possesses extensive experience and a thorough understanding of regulatory requirements. We have successfully assisted numerous clients in achieving and maintaining compliance, with projects regularly audited against regulatory standards.
Flexible Approach
Valcomm is committed to working within the client’s existing commissioning and qualification frameworks if required. Our team adapts to your specific needs while maintaining regulatory compliance and delivering tailored solutions that fit your project’s demands.
Regulatory Compliance
With deep expertise in GMP (Good Manufacturing Practice) and industry regulations, Valcomm ensures that all qualification activities are conducted in line with applicable standards. Our projects are regularly audited against regulatory requirements, providing clients with confidence in the quality and compliance of their systems and processes.
Cost-Effective Solutions
By implementing the latest methodologies and a structured approach, Valcomm helps clients reduce overall validation costs without sacrificing quality.
Diverse Industry Knowledge
With experience across a variety of sectors, we understand the unique challenges faced by each industry. From equipment validation and cleaning validation to process qualification, Valcomm ensures that your specific needs are met with expertise and precision.
Why you need Compliance and Validation
- Compliance ensures that organisations follow the necessary legal and regulatory frameworks.
- Validation ensures that specific processes, systems, or products are operating as intended.
- Together, they protect businesses from legal risks, enhance product quality, build trust, and improve operational efficiency.
Maintaining a compliance through validation offers the following key advantages
Regulatory Requirements
- Meet your Legal Obligation
Many industries, like pharmaceuticals, medical devices, food manufacturing, and aerospace, are subject to strict regulations. Compliance ensures you meet standards set by governing bodies like the FDA, MHRA, ISO, or GxP (Good Practices). - Avoid Penalties
Non-compliance can lead to fines, sanctions, product recalls, or even business closure.
Product Quality and Safety
- Ensures Consistency
Validation confirms that equipment, processes, and systems consistently produce the intended quality outcomes. - Protects Consumers
Compliance reduces the risk of harm caused by faulty products or processes, ensuring safety for end-users.
Risk Management
- Identify and Mitigate Risks
Compliance frameworks help identify potential risks and implement preventive measures. - Audit Readiness
Having validation processes in place ensures you’re always prepared for regulatory audits.
Operational Efficiency
- Process Optimisation
Validation streamlines workflows, reduces variability, and improves efficiency and reliability in operations. - Reduces Errors
Validated systems and processes are less prone to errors, minimising downtime and production delays.
Market Trust and Reputation
- Customer Confidence
Compliance with standards builds trust and credibility with clients and consumers. - Competitive Advantage
Companies with rigorous validation and compliance practices are often preferred in the market.
Data Integrity and Security
- Accurate Records
Compliance ensures that data is accurate, complete, and secure, which is crucial for decision-making and regulatory reporting. - Prevent Data Breaches
For industries like healthcare, compliance with data protection standards (e.g., HIPAA, GDPR) safeguards sensitive information.
Our areas of expertise include
Computer system validation
Through our regulatory software testing and validation services, we ensure that key business systems are functional and in compliance with applicable regulations – including planning, protocol development, execution and systems qualification – to minimise business risk.
Equipment validation
Our rigorous equipment validation ensures every aspect of your equipment meets regulatory standards, minimising risk and maximising competitiveness.
Analytical method validation
Analytical method validation is a critical process. It involves a series of tests to verify that the method is specific, sensitive, linear, accurate, precise, and robust.
GMP principles
Adherence to GMP principles is crucial for industries such as pharmaceuticals, food, and cosmetics, as it helps prevent contamination, errors, and product recalls.
Cleaning validation
This involves demonstrating that cleaning procedures are effective in removing contaminants and preventing cross-contamination, meeting all relevant regulatory requirements and industry standards, and providing documented evidence of the validation process.
Final product testing
Final product testing is a detailed evaluation method that involves both verification and validation. These processes are essential for ensuring the quality, reliability, and effectiveness of products, services, and systems.
Risk assessment
This process identifies potential risks and strategies to mitigate them. It can help ensure that resources are focused on the most critical areas and can lead to cost savings.
Design qualification
Design qualification (DQ) is a documented process that verifies a system, facility, or equipment’s design is suitable for its intended purpose. It’s a key element in the validation of new systems, equipment, or facilities.
Installation qualification
Installation qualification (IQ) is a quality assurance protocol that verifies that a piece of equipment has been installed and configured correctly. It ensures that the equipment meets the manufacturer’s specifications and is suitable for its intended environment.
Operational qualification
Operational qualification (OQ) is a formal process that ensures equipment operates as intended and within the manufacturer’s specified parameters. It’s a key part of the process validation process, along with IQ and PQ.
Performance qualification
Performance Qualification (PQ) is a validation process that ensures equipment consistently delivers accurate results under real-world conditions. It’s an ongoing quality check involving repeated testing throughout the equipment’s lifespan.
Validation master plans
A Validation Master Plan (VMP) is a document that summarises the planned validation activities for a project, including calibration and validation.
Control systems commissioning/validation
Our control system engineers provide full system testing and qualification from stand-alone Programmable Logic Controller (PLC) systems to large-scale networked Distributed Control Systems (DCS), Supervisory Control and Data Acquisition (SCADA) systems with multiple applications and interfacing elements.
ERES (Electronic Registers & Electronic Signatures) assessment
Our experienced professionals are extensively trained to evaluate a client’s use and documentation of electronic records and electronic signatures as governed by applicable regulatory requirements.
Documentation
We have proven qualification systems that can be tailored to any application following typical life cycle methodologies. It is adaptable to assure compliance through any project whilst adopting many specific technical processes.
Auditing
Our audit services follow a proven methodology to evaluate organisational structure, policies, procedures, and practices concerned with facilities and systems associated with this highly regulated industry. We can tailor audits to your requirements, be it a pre-regulatory inspection audit or a full GAP analysis audit to highlight weak areas.
Outsourcing
We offer tailored levels of on-site resourcing covering commissioning, qualification and project management over short or long-term contracts.
Good distribution practice (GDP) in Cold Chain Logistics
Due diligence in cold chain logistics extends beyond simply selecting a qualified shipper. To ensure optimal performance and minimise costs, it’s essential to commission a transit study to evaluate your entire shipping process. This comprehensive analysis will identify opportunities for improvement, reduce material losses, and optimise your shipping strategy. By understanding the strengths and weaknesses of different shippers and transport options, you can make informed decisions to achieve the most cost-effective and reliable cold chain solution.