We offer to help you create or update Policies and SOPs for you in concordance with your company culture and work environment.

Basic Quality Management SOPs

We work with you to create or evolve basic quality management SOPs, e.g.

  • SOPs on SOPs
  • Training
  • Risk Management
  • CAPA
  • Vendor Qualification
  • Audits
  • Data Privacy

Computer System Validation SOPs

With our extensive experience in the field of Computer System Validation we can support in the generation of SOPs in the area of Computer System Validation, e.g.

  • Validation Masterplan
  • Infrastructure Qualification
  • Software as a Service/ Cloud Application Validation
  • Computer System Validation
  • IT Operations
  • Electronic Signatures

SOPs on the use of electronic Solutions

Often companies need support with the creation of SOPs for the use of electronic solutions. We can support you in creation of such SOPs, e.g. for

  • Data Management
  • Biostatistics
  • Electronic Trial Masterfile

User Manuals

If you have implemented a new IT system and need to create user manuals without having the time to do so we gladly support you.