Validation & Documentation – Delta ModTech
Workers in cleanroom suits operate a labeling machine with rolls of labels.

Validation & Verification Support

We connect engineering, verification, testing, and documentation into one validation-ready process, helping you reduce uncertainty and move toward qualified production with confidence.

Your Partner In Compliance

Bringing new equipment into regulated production is complex. We help simplify it with validation and verification documentation support built into your project from the start. With practices modeled after GAMP 5 and supported by ISO 9001-certified procedures, we help you plan, test, document, and move toward qualified production with confidence.

Validation Workflow Overview 

The Delta ModTech validation approach follows a clear, structured progression aligned with industry best practices and a variety of international standards. 

Review URS

Mitgate Risk

Build To SPec

Verify and Prove

Support SAT

Production REady

Validation considerations are addressed at each stage to ensure requirements, specifications, testing, and documentation remain traceable throughout the machine lifecycle. 

What we support

  • Regulated manufacturing environments requiring structured equipment validation 
  • FDA‑regulated applications and systems supporting 21CFR Part 11 
  • Manufacturers seeking to reduce time to market, internal validation workload and/or external consulting costs

Streamlined Verification

Verification and commissioning activities are performed using adaptable, functional testing methods that mirror Delta ModTech’s modular machine architecture. This approach ensures each subsystem and corresponding software function performs as intended before final acceptance.

Factory‑Level Testing

Get earlier visibility into machine performance before installation at your facility.

  • Design, software, and machine function verification performed by Delta ModTech personnel
  • Verification confirms machine function. Validation confirms the machine meets specification requirements
  • Factory Acceptance Testing (FAT) conducted at Delta ModTech prior to shipment, with customer participation encouraged

21 CFR Part 11 Software

Need to address FDA 21 CFR Part 11? Our systems include tools that support electronic records, audit trails, and electronic signatures.

Key Software Features:

  • Secure user authentication and role‑based access
  • Event logging of parameter changes by user ID 
  • Time‑stamped audit trails stored in an SQL database 
  • Backup‑ready electronic record management

Configure these tools to align with your user administration, backup, and record retention policies.

SAT & Qualification Support

Support your site qualification with IQ and OQ protocols built for execution at your facility.

Need help during SAT or qualification execution? We can support your team on site or remotely. PQ remains your responsibility, but we help give you the documentation foundation to get started.

Need more support? We can provide additional documentation and execution support on a time-and-material basis.

Validation Documentation Deliverables

  • Validation Project Plan 
  • Functional Design Specification (FDS) 
  • Software Design Specification (SDS) 
  • Hardware Design Specification (HDS) 
  • Traceability Matrix
  • Failure Mode and Effects Analysis (FMEA) 
  • Design Verification Test Documents and Execution
  • Software Verification Test Documents and Execution
  • Machine Function Verification Test Documents and Execution
  • Validation Summary Report 
  • Installation Qualification (IQ) Protocol 
  • Operational Qualification (OQ) Protocol

Ready to simplify validation? Contact us to discuss documentation, qualification, and commissioning support for your next machine project

Contact us

On Site Capabilities

In addition to our production converting and lab equipment, we have a Laser test lab, Optical Comparators, High-speed camera’s, Peel Tester and a variety of other resources onsite to help aid you in the development and validation of your products and processes.

Ryan Herman

From curious questions to preparing a quote, we’re ready to help.

Whether we’re answering some introductory questions or if you’re in need of a quote, just fill in the form or call us at 1-800-279-3358 and we can get you the answers you need.