Commissioning, Qualification & Validation
Valcomm assists clients in Commissioning, Qualification and Validation activities ranging from simple 'as built' documentation to complete process qualification for complex manufacturing environments. This goal has been archived Using our CCQ System (Combined Commissioning & Qualification), however we maintain the flexibility to work within the refines of the clients commissioning and qualification methodologies should the need arise.
Our extensive experience and our thorough knowledge and understanding of regulatory requirements have assisted many clients to achieve and maintain compliance. Our projects are regularly audited against the requirements of the regulators.
We are committed to providing the latest thinking in a cost effective and practical manner. The right approach can reduce validation costs.
Our areas of expertise include:
- Equipment and Systems commissioning
- Computer System Validation
- Equipment Validation
- Analytical Method Validation
- Raw Materials Specifications
- GMP Principles
- Cleaning Validation
- Final Product Testing
- Risk Assessment
- ERES assessments
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Validation Master Plans
- Process Qualification
Commissioning:
Using our CCQ System (Combined Commissioning & Qualification) we ensure our clients duplication of testing is eliminated by adopting proven GEP (Good Engineering Practices) through all phases.
Computer / Business Systems 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.
Control Systems Commissioning / Validation:
Our Control System Engineers provide for full system testing and qualification from stand alone PLC systems to large-scale networked DCS, SCADA systems with multiple applications and interfacing elements.
Process / Equipment Validation:
We ensure our clients that all elements of the manufacturing process are validated in compliance with applicable regulations to minimise their business risk and to enhance their ability to compete successfully in the marketplace.
Part 11 / 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 a proven CCQ System (Combined Commissioning & Qualification) that can be further tailored to any application following typical Life Cycle methodologies which is adaptable to assure compliance through any project whilst adopting many specific technical processes.
Auditing:
Our audit services follow a proven methodology to evaluate organizational structure, policies, procedures, and practices concerned with facilities and systems associated with this highly regulated industry. We can tailor audits to your requirement, 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.