At your side even in turbulent times. The Chemgineering QA-Helpdesk

The current corona pandemic poses major challenges for manufacturing companies in highly regulated industries such as pharmaceuticals, biotech, fine chemicals and medical technology. In addition to the general concern for the health of employees, there are organisational difficulties such as bottlenecks due to absent staff and a simultaneous sharp increase in the demand for medicines, protective clothing, disinfectants and their basic materials. In order to continue to reliably meet this demand, production in these areas must be ramped up to a maximum, which requires additional personnel.

Although many regulations have currently been relaxed in order not to endanger the supply of these urgently needed products, the companies must of course also maintain their compliance and document and prove it based on their QM system. Audits have to be carried out and validation documents have to be prepared, in addition to the daily business, which still has to be managed efficiently.

Our consultants and engineers now also work almost all from their home offices, which is possible without any problems thanks to our IT infrastructure. We can therefore continue to provide you with almost unlimited access to our services and support you in these challenging times with our QA helpdesk.

With an experienced and skilled team, we support you via WebEx, telephone and video conferencing to balance out bottlenecks and continue to produce efficiently and compliantly. Remote access to documentation and management systems allows audits to be carried out without the physical presence of the auditor. Telephone, video conferencing and web-based tools also allow a high degree of flexibility.

We support you remotely with the following services:

  • Compensation of personnel bottlenecks
  • Processing of deviations and CAPAs
  • Remote audits (remote & video conference)
  • Creation of SOPs
  • Creating PQRs
  • Creation of validation documents (process validation, cleaning validation, method validation)
  • Creation of QM documents
  • Reviews of all kinds (e.g. QA documents, validation documents)
  • Advice on the production of disinfectant (= biocide)
  • Consulting for the production of mouthguards (= medical device) 
  • Risk analyses via video conference

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