QC2 provides tailored Standard Operating Procedure (SOP) services designed to meet the unique requirements of your project and budget:
SOP Gap Analysis
QC2 performs gap analyses on SOPs, work instructions, and related documents to ensure they meet current regulatory standards, including 21 CFR Parts 11, 50, 54, 56, 58, 312, and 314, as well as ICH GCP guidelines. This process also includes a comparison against industry benchmarks and best practices. We provide constructive feedback aimed at enhancing workflows, and we identify any additional quality measures, best practices, or modifications necessary to comply with regulatory requirements.
SOP Review and Revision
Qc2 reviews and revise SOPs to ensure compliance with GCPs, GLPs, cGMPs, ICH guidelines, and current industry standards and best practices, and also to confirm that the SOPs reflects current processes.
SOP Preparation
QC2 prepares new SOPs and frameworks for SOP systems that adhere to GCPs, GLPs, cGMPs, applicable regulations, and ICH guidelines, while also incorporating current industry standards and best practices.
