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
- 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.