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C&Q Commissioning & Qualification

Commissioning is an essential element for efficient qualification and further validation efforts, assuring project success. Telstar, as a leader in these competences, has developed an integrated strategic approach where Engineering and Consultancy work together to achieve the most important business goals: compliance with current regulations, cost-effective qualification, formality, and documentation commensurate with the level of risk, and aiming to leverage testing activities.

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We help customers to position their Commissioning & Qualification Strategy

Considering the quality systems policy, the nature of manufacturing systems and the risk-based culture.

In the ASTM E2500, DQ, IQ, OQ and PQ phases are no longer mentioned. The traditional approach may be replaced by cost-effective activities such as Good Engineering Practice and verification by the role of the Subject Matter Experts. Applying the ASTM E2500 approach, it is possible to reduce costs by enabling efficiency improvements, based on science and on risk management. The guideline describes a risk and science-based approach for systems and equipment which includes requirements, specification, design, verification, acceptance, and release. This is the Commissioning and Qualification (C&Q) concept of Telstar, which significantly avoids excessive reviews/approvals for each protocol and duplication of efforts.

Telstar, as a “Full-Service Provider”, has got the expertise which helps customers to move from established and traditional commissioning to a more efficient science and risk-based framework, with the minimum impact on their current practices. Science, risk assessment and process knowledge will be used to identify critical elements and critical aspects to modify your process to provide you with a high degree of assurance.

All the validation deliverables through the validation life cycle (starting with the URS) will focus on product quality and all the testing activities will be used efficiently to give documented evidence that system performance meets products and process user requirements.

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