How do quality management and document management interact in the pharmaceutical and biotech industry?

Qualitätsmanagement und Dokumentenmanagement in der Pharma- und Biotechbranche

In the pharmaceutical and biotech industry, quality management has a high priority as it is essential for the safety and efficacy of medicines and medical devices. An important component of quality management is document management, as it is essential for the effective administration and monitoring of quality standards and processes.

Document management involves the creation, management and storage of documents and records required for compliance with quality standards and processes in the pharmaceutical and biotech industry. This includes, for example, standard operating procedures (SOPs), protocols, test results, approvals and other records.

Effective document management is essential for a quality-conscious company. It helps ensure that all employees have access to the latest documents and records to ensure compliance with quality standards. It also ensures that important documents and records are stored securely and protected from unauthorised access.

Another important aspect of document management is traceability. In the event of a quality deviation, it is important to have all documents and records in order to determine the cause and take action to prevent future deviations. Effective document management also ensures compliance with regulatory requirements and standards that apply to the pharmaceutical and biotech industry.

Digitisation of documents and records also plays an important role in this context. By using electronic systems, documents can be created, stored and retrieved more efficiently. A digital platform can also enable faster and more effective collaboration between different departments, teams and external suppliers and service providers. Docuply is a suitable solution that works especially well for smaller companies and start-ups.

In summary, effective document management is essential for successful quality management in the pharmaceutical and biotech industry. It ensures compliance with quality standards, the safety of medicines and medical devices, and compliance with regulatory requirements and standards. Digitising documents can help optimise processes and improve collaboration.

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Quality management in the pharmaceutical and biotech industry: Current challenges in the cooperation between pharmaceutical companies and CROs, CMOs and CDMOs

"The increasing decentralization of the supply chain in the pharmaceutical industry poses major challenges for companies. In a regulated environment, regulatory requirements must be implemented in a compliant manner while adhering to "Good Documentation Practice" with business partners in a global environment. The global networking and faster availability of information in large numbers are pushing our existing document management systems to their limits in terms of timely processing in compliance with GMP requirements. Therefore, we need to rethink our current way of working to enable effective and efficient document management with new IT solutions."

Timur Güvercinci
Timur Güvercinci