Change Control Management

Change control in life science is critical to the company's quality management system. As such, insufficient change control procedures can end up generating a huge risk of non-compliance.

Change control for FDA regulated companies

DA regulated companies must be able to implement a quality system that automates change management and change control procedures, ensuring that they are in compliance with GMP and CFR Part 11.

Change control management ensures that changes to a product or system are evaluated and implemented in a controlled manner. This procedure involves evaluating the effect and risks of change, as well as guaranteeing that the planning, co-ordination and implementation of a change are carried out in an efficient and safe manner.

Predefined processes for change control

With predefined processes for managing changes fundamental to maintaining high product standards and process quality, the best solution is Platina QMS Software. This solution includes predefined processes to certify that changes in a product or some other relevant change (e.g. machinery, computer systems, etc.) are co-ordinated in a controlled way. In doing so, this lessens the risk that changes are implemented without prior formal process or that the requirement for this particular change was not followed.

Change control compliance for life science industry

Platina QMS Change Control ensures that organisations within the life science sector comply with the regulatory 21 CFR Part 11 requirements. Automated processes guarantee the quality of change and decision-making, through checking that the right people are involved at the right time, from initiation and analysis, to validation and approval.

Platina QMS Change Control provides total clarity throughout. A change that is to be introduced may also be connected directly to other processes related to quality management, such as Platina QMS SOP Management and Training. What’s more, a broader overview of both current and completed change control processes is achieved.

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