Validation is an FDA requirement for compliance with cGMP and the Quality System Regulations (QSR). S2EC offers current Good Manufacturing Practices (cGMP) services for pharmaceutical and medical device industries. Our services include: Master Plan Development IQ/OQ/PQ Protocol Development for equipment software, and automated systems Protocol Execution cGMP/QSR/GDP Training GMP, GDP, QSIT Auditing Statistical Process Control (SPC) Analysis (including Process Capability Studies) Resolution of Deviations Gap Analysis CAPA System Development Risk Assessment User Requirement Specifications Functional Requirement Specifications Software Requirement Specifications Batch Record Review Standard Operating Procedure (SOP) Development   Many companies are faced with complying with requirements for multiple federal agencies or certifying organizations (i.e. EPA, FDA, OSHA, ISO, etc.) S2EC will help you fuse these requirements into one workable system that meets the needs of all.