Indian Rocks Beach, FL 33785
(727) 642-0182
(813) 774-8657
(727) 593-3595 FAX
"Helping People Learn Compliance and Science" SM
SOP Writing
SERVICE DESCRIPTION
Standard Operating Procedures (SOPs) are written documents which detail common policies, practices and procedures within an organization. SOPs make up an essential component to any CGMP operation and are required by 21 CFR 211. Traditionally, SOPs are difficult and time consuming to create, often impossible to follow as written, and lead to numerous errors when they are executed by the personnel who are required to follow them. Because of this many CGMP facilities are in substantial need of an upgrade to their SOPs and SOP generation, review, approval, and revision system.
Delphi Analytical Services has developed a process called The V-SOP© System which eliminates most of the obstacles associated with traditional SOP generation. The V-SOP© System is an organized and logical process for creating more effective and useable SOPs. It generates written documents whose usability is greatly enhanced by imbedding hyperlinked digital video and picture elements directly into the documents.
If digital and video elements are not desired then a modified approach to SOP generation can be taken using the processes described in The V-SOP© System. This approach is still extremely effective in creating or modifying standard written documents, and represents the industry’s best practices.
WHO WILL VALUE FROM THE SERVICE
The following organizations will benefit from these services:
• New companies currently in the process of creating a CGMP compliantdocumentation system
• Any company who in substantial need of an upgrade to their SOPs and SOP
generation, review, approval, and revision system.
ADMINISTRATION
All consulting service contracts are individually negotiated. Please contact us directly for more details or to request a proposal or site visit.
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