SOP Types & Documentation Services

Comprehensive Standard Operating Procedure (SOP) development services for biotech and pharma companies. Our SOPs ensure regulatory compliance, reproducibility, and quality assurance.

IHC Assay SOPs

▸ Antibody validation protocols
▸ Staining procedures (singleplex & multiplex)
▸ Antigen retrieval methods
▸ Detection system protocols
▸ Counterstaining procedures
▸ Quality control checkpoints
▸ Antibody titration procedures
▸ Blocking and incubation protocols

Histology Workflow SOPs

▸ Tissue processing protocols
▸ Embedding and sectioning procedures
▸ H&E staining workflows
▸ Special stain protocols
▸ Slide preparation and labeling
▸ Equipment maintenance procedures
▸ FFPE block preparation
▸ Microtome operation and calibration

Quality Control & Validation SOPs

▸ QC testing procedures
▸ Positive/negative control protocols
▸ Assay validation documentation
▸ Troubleshooting guides
▸ Deviation handling procedures
▸ Documentation and record keeping
▸ Analytical validation protocols
▸ Clinical validation procedures

Digital Pathology SOPs

▸ Whole slide imaging protocols
▸ Image analysis workflows
▸ HALO platform procedures
▸ Data management and storage
▸ Image quality assessment
▸ AI/ML validation protocols
▸ Slide scanner operation and maintenance
▸ Digital image annotation procedures

Regulatory & Compliance SOPs

▸ FDA compliance documentation
▸ CLIA laboratory procedures
▸ CAP accreditation protocols
▸ ISO 15189 compliance procedures
▸ GxP documentation standards
▸ Audit preparation procedures
▸ Change control documentation
▸ Regulatory submission documentation

Equipment & Instrumentation SOPs

▸ Microscope operation and calibration
▸ Automated stainer protocols
▸ Slide scanner maintenance
▸ Temperature monitoring procedures
▸ Equipment validation and qualification
▸ Preventive maintenance schedules
▸ Equipment troubleshooting guides
▸ Calibration and verification procedures

Ready to Get Started?

Contact us to discuss your specific SOP requirements. We'll work with you to develop comprehensive, compliant documentation tailored to your laboratory's needs.

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