Standard Operating Procedures (SOPs) are written procedures for any process that must be followed in an operation of a system including IT systems, computer software, laboratory equipment, and manufacturing systems.

USDM offers two types of SOP solutions; 

1) Pre-packaged SOP templates that include 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:

IT SOP templates include;

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

Validation SOP templates include;

  • Computer System Assessment
  • 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

Supporting Process SOP templates include;

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

Contact USDM to discuss your SOP needs today. For start-up companies, read our checklist of top-10 SOPs required to implement and validate your first GxP regulated IT systems on your journey to commercialization.

For SMB 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 here for a case study on how USDM was able to create 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

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley

Vice President of Medical Device Solutions and Services

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