FDA Compliance is specifically designed for medical device, food, pharmaceutical and biotechnology manufacturers. It provides the technical control required to support the US Food and Drug Administration's 21CFR Part 11 regulation. This includes standardized control over the management of electronic records of the entire product development process, without need for customization, including all required components of 21 CFR Part 11 such as enhanced User Authentication procedures, Audit Trail records of changes, Electronic Signature support, following standardized workflow processes, and Query Mechanism for retrieving Audit Trail information. Let Process PassPort Inc. assist you in validating your Equipment and Process Software for the Pharmaceutical industry.  Our team of trained professionals has first hand experience with FDA GxP and 21 CFR Part 11 requirements.  Process PassPort Inc. will help your enterprise stay compliant by: Providing training on regulatory requirements Evaluating current software development practices Providing independent auditing and document review services Facilitating risk assessments and mitigations Assisting in developing and implementing Standard Operating Procedures (SOPs) and Software Life Cycles (SLCs) Aiding in designing and implementing validation plans and change control procedures Collaborating in authoring SLC documents, such as; Design Specifications, Functional Specifications, Software Design Requirements, Test Protocols and Summary Reports.