Process Validation Services

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.

THERMAL / TEMPERATURE MAPPING:

Being a critical factor in many processes and storage facilities and due to the potential “down Time” required for execution of thermal mapping studies, it is paramount that the critical components for a successful conclusion are in place. This can only be achieved by extensive knowledge and the use of state-of-the-art equipment which we are proud to offer.

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.

PART 11 / ERES 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.

OUTSOURCING:

We offer tailored levels of on-site resourcing covering commissioning, qualification and project management over short or long term contracts. We have the flexibility and depth of talent in our team.

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.

PROJECT MANAGEMENT:

Implementing or upgrading a GxP compliant facility / system on time and within budget requires experienced project management. We offer proven techniques / systems assuring that project management is the essential component for success.