Regulatory Compliance & Validation

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 This goal has been archived using our Combined Commissioning & Qualification (CCQ) system. 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 we ensure our clients duplication of testing is eliminated by adopting proven Good Engineering Practices (GEP) 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 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.

Process / equipment validation

We ensure our clients that all elements of the manufacturing process are validated in compliance with applicable regulations to minimise its business risk and to enhance its ability to compete successfully in the marketplace.

Electronic Registers & Electronic Signatures (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.

Documentation

We have a proven CCQ system that can be further tailored to any application following typical life cycle methodologies that 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.
To discuss your specific mapping requirements please contact us today.

Good distribution practice

Due diligence in cold chain means not simply using a qualified shipper, but qualifying the shipper to perform within the entire shipping process, whether overnight, or extended periods of time to another region. Commissioning a transit study to qualify your shipping system will lower costs including dramatically reducing loss of material and the repetitive testing of suspect material.

A transit study will allow you to identify when a more expensive shipper combined with a less expensive transport option is more cost effective than a less expensive shipper, combined with occasional use of a specialised courier service.

 


Quality assured with expertise and accreditation

CALL TODAY  +44 (0) 1279 909 13

UKAS-Cal-7789-BW-3cm

 

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