Software Services

SQM, Inc. offers a wealth of knowledge regarding Software needs and provides reliable, on-target, and practical solutions through the following Software Services: 

Software Lifecycle
  • Audits

  • SOPs, Forms, Templates and Checklists

  • Risk Management

  • Hazard Analysis

  • Training

  • Gap Analysis

  • 21 CFR Part 11 (Electronic Signatures; Electronic Records)

Software Validation and Verification
  • Validation

  • Verification

  • Testing

  • Test Plans

  • Test Execution

  • SOPs, Forms, Templates and Checklists

Software Documentation

 

  • Prospective and Retrospective Documentation

  • Design Controls

  • IQ (Installation Qualification)

  • OQ (Operational Qualification)

  • PQ (Performance Qualification)

  • SOPs, Forms, Templates and Checklists

  • Submissions

Software as a Medical Device
  • Regulatory Strategy

  • Inspections

Software as a part of a System
  • Regulatory Strategy

  • Inspections

 

SQM Inc. can provide various levels of support individually tailored

for your special needs!


Software Quality Management, Inc. (SQM), 2 Southerly Court, Suite 603, Towson, MD, 21286, USA, 410-339-5307 (v), 

410-823-8019 (f), info@sqminc.com, copyright SQM, 1997-2002, Last modified: November 18, 2009