Compliance and Quality

Competences

Compliance and Quality

Various laws, standards, and guidelines place stringent requirements on firms in the regulated industries; compliance to completion of these requirements is often a first step in gaining access to the market and consumers. GxP, Annex 11, cGMP, 21 CFR, ISO 9001, and ISO 13485 etc. are among the relevant requirements.

Adjustments to specific parts and interpretations of regulatory requirements have to be anticipated proactively, evaluated correctly, and implemented efficiently. This approach is crucial for your organization’s compliance.

A company’s quality management system (QMS) is a key success factor in the implementation of such activities to ensure compliance.

  • Is your QMS compliant with current regulatory requirements?
  • What about data quality and data integrity in your organization?
  • Can you ensure and maintain compliance at every level of your company?
  • How well are you prepared for future audits?

Our responsibility, our standard

Thescon support strategies include a preliminary “Quick-Check” of your QMS, gap analysis, and close collaboration during preparation and execution of audits. Moreover, we work with you during the qualification of your suppliers.

We help you successfully implement the complex requirements for unique device identification (UDI) and serialization, data governance, product data and master data management.

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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 and 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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