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 client, 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.

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BobLucchesi
Bob

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay

Vice President of Unique Device Identification Solutions

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