Validation and Qualification

Competences

Validation and Qualification

In the regulated industries, numerous laws, conventions and guidelines (GxP, GDP, cGMP, 21 CFR, ISO 13485, FMD, MDR etc.) require the validation of computerized systems such as ERP systems as well as the underlying IT infrastructure qualification.

Computer system validation (CSV) serves as documented evidence of the functionality of a system for a guarantee of product quality, patient safety and data integrity (GxP compliance).

Change management processes ensure continual maintenance of the valid and qualified system status. It is an essential component of the company’s quality assurance.

  • Which of your systems are GxP relevant and therefore need to be validated?
  • What is the scope and sequence of the validation?
  • How can you achieve and maintain a valid system status?
  • Which approach fits best to your validation project from a compliance point of view?

Our responsibility, our standard

Thescon supports you in answering these questions as well as in the management of the resulting project. Based on a risk-based approach, we find an individual and efficacious validation strategy for your company.

Working together with you, we optimize process and data flow models and train your employees to develop a sense for GxP compliance. We support you throughout the validation and qualification process to ensure your long-term success.

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Competences

Validation and Qualification

In the regulated industries firms have to comply with extensive and challenging regulations. Such compliance includes the validation of IT systems as well as the qualification of the underlying infrastructure.

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Compliance and Quality

A good quality management system is in­dis­pensable in the regulated industries for com­plying with legal stipulations. Further, con­tinuous system maintenance and im­prove­ments to the quality management system con­tributes directly to the success of a firm.

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Software selection & Process management

Choosing a new IT software poses a crucial challenge for companies in the regulated industries. Therefore, a well-organized and transparent software selection process is essential in choosing a provider that best suits to the company.

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Infrastructure Qualification

Regulated industries must meet important and legal infrastructure qualifications. If the qualification does not follow those guide­lines, unauthorized system access and data manipulation may become real threats to the organization.

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