Standard Operating Procedures (SOPs) are written procedures that ensure essential job tasks are performed according to approved procedures.

USDM offers two SOP solutions:

  1. Pre-packaged SOP solutions: This includes templates for select IT or Quality processes based on common regulatory requirements and industry best practices.
  2. Support for creating customized SOPs that include the pre-packaged SOPs, plus additional customized or original SOP development to meet your specific needs and intended use cases.

Pre-Packaged SOP Templates

Pre-packaged SOP templates include select IT or Quality processes based on common regulatory requirements and industry best practices.

IT SOP templates and related forms include:

  • Change Control
  • Security Administration
  • Record Retention
  • Data Integrity Policy and Procedures
  • System Access and Password Control
  • System Administration
  • Audit Trail Review
  • Electronic Signature Policy and Procedure (includes Acknowledgement Form)
  • Backup and Restore
  • Disaster Recovery

 Validation SOP templates and related forms include:

  • Computer System Validation (CSV)
  • Part 11 Assessment
  • Master Validation Plan
  • Risk Assessment
  • Master Inventory List
  • Decommissioning
  • Periodic Review and Assessment of Validated Systems
  • Configuration Management
  • SDLC for Custom Systems
  • Change Management
  • Validation documentation templates, including:
    • System Validation Plan
    • User Requirements Specification
    • Functional Requirements Specification
    • Risk Assessment Form
    • Configuration Specification
    • Test Protocols and Test Script
    • User Log
    • Deviation Form
    • Trace Matrix
    • Validation Summary Report
  • Computer Software Assurance (CSA) templates and related forms include:
    • System Life Cycle with coverage for:
      • Regulated Systems Governance (4 phases: planning, implementation, production, and retirement)
      • Roles and responsibilities aligned with your organization’s capabilities
      • IT System Inventory
      • CSA approach to initial validation and release management
      • Regulatory Applicability Assessment (RAA) Form
      • ERES Compliance Assessment Form
    • IT Risk Assessment 
    • IT Change Control for Regulated Systems and form (for GxP and SOX)
    • Periodic Review and form

Supporting Process SOP templates include:

  • Vendor/Supplier Management Program
  • Data Integrity Program
  • Risk Management
  • Document Management
  • Infrastructure Qualification 

Customized Standard Operating Procedures

If your medical device, pharmaceutical, or biotech organization requires a more tailor-made solution, USDM can work with your team to upgrade your quality system. We will review the current state of your SOPs and create new ones to achieve your goals.

Discounted pricing is available for customized SOPs in quantities of 1-5, 6-10, or 10+ to meet your unique business need. Customized SOPs include pre-packaged SOPs.

What SOPs Do I Need?

For start-up and pre-commercial companies, read our best practices approach for implementing and validating your first GxP-regulated IT systems on your journey to commercialization.
 
For commercialized and larger companies, learn how USDM helped a large medical device manufacturer upgrade their quality system by revising 400 SOPs and generating CND codes to prepare for EUDAMED submissions.
 
Or read this case study to learn how USDM created standardized processes that saved our customer, a global contract biopharmaceutical manufacturer, over half a million dollars for five sites over two years.

Thought Leaders

Leading experts in every Life Sciences field.

Learn More
Bob Lucchesi
Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services

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