Penny Goss Technical Solutions

The key to our service is that we bring a commonsense approach to every project we are a part of.  At PGTS we want to be your documentation resource, not your one time connection.

The FDA requires that software systems used for quality purposes in place of paper records be validated for their intended use [Title 21 CFR Part 820.70 (i)].  This means that when using configurable off the shelf (COTS) systems, companies must verify that the software is configured correctly to meet their business needs.  Even if you are intending to do a relatively vanilla implementation you need to have documented evidence verifying that the system was correctly installed and configured correctly. 

The following is a list of many of the services provided by PGTS: 

  • Software Validation / Verification: Concept/Proposal Documents, Validation Plans, User and Functional Requirements Specifications, Risk Assessment Reports, Software Design Specifications, IQ/OQ Documentation, Test Protocols and Test Reports
  • FDA 21 CFR Part 11: Developed evaluation and remediation planes for guideline compliance.  When I implement systems which use electronic signatures I help my clients with all the areas where this reg applies not just the system piece.
  • Audit Remediation: Worked with QA and Regulatory Affairs to remedy audit findings 
  • Gap Analysis: Perform system and software gap analysis for fiscal decisions
  • Merger & Acquisition Quality Data Migration: validation to evidence that data from purchased companies was properly merged with existing quality systems.
  • RFP & Proposal Writer: 20+ years of Request for Proposal and proposal response writing experience (resulting in individual contracts of over 1 million dollars)
  • SOP & DOP: Generation and revision of operation procedures for quality assurance purposes
  • Work Instructions: Develop work instructions specific to customer use of software application
  • Business Process Flow Mapping: Proficient with developing current and optimal state business process flowcharts
  • Presentation Developer: Robust PowerPoint presentations
  • Workflow & Process Diagramming: Visual diagrams of workflow and process flow for development and documentation purposes.
  • Technical Manuals: User guides, Service Provider Manuals and Release Notes
  • Supplier/Vendor Audit: Traveled to software vendor site to perform GMP compliance assessment and generate report.