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Software and Process Validation Support Services
Synergy Resources combines 20+ years of ERP experience with 20+ years of Medical Device Manufacturing and Quality Management Experience to offer comprehensive Business Process and Software Validation Solutions for the complex Medical Device Regulated Industry
icon Industry Experts

Industry Experts

Our consultants have a deep knowledge of FDA regulations and will provide the appropriate level of support to guide you through your validation project.
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FDA Validation & Test Scripts

Our test cases improve adherence to standards while documenting GMP risk processes.
icon Validation Process Framework

Validation Process Framework

Our prepackaged templates will improve the efficiency of your Regulatory Team.
<span>FDA 21 CFR 820 - ISO 13485:2016</span>

FDA 21 CFR 820 - ISO 13485:2016

Both the FDA Code of Regulation 21 CFR 820 and ISO 13485:2016 require that all processes associated with designing, manufacturing, packaging, labeling, storing, installing, or servicing a Medical Finished Device must be validated. The extent of the validation is determined by whether the process is “Fully Verifiable” or not.

The validation determines, defines, governs, and documents the formal testing of Good Manufacturing Practices (GMP) and relevant activities pertaining to the definition, production, and delivery of regulated products and services. If it is unclear as to which areas of your business might need FDA validation, the FDA provides guidance www.FDA.gov.

In addition, any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use. This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.

<span>Three System Validation Approach</span>

Three System Validation Approach

  • ERP System Validation

    Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use. This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system. A common mistake while implementing a validated ERP System is not including other ERP related software such as Microsoft Excel, other Microsoft tools, and various Product Realization reports within the Validation Master Plan. This common mistake results in “Non- Compliance” to the various regulatory requirements.

  • Quality Management Systems Validation

    Quality Management Systems include various product realization elements such as Non-Conformance Management, CAPA, Device Calibration, Data Analysis etc. These QMS Elements require Software Validation and must be included within the Validation Master Plan.

  • Direct Manufacturing Process Validation

    Direct Manufacturing Processes such as Machining, Cleaning, Passivation, Finishing etc., must be validated. The extent of the validation is determined on whether the process is fully verifiable or not. In certain instances, a simple Equipment Qualification may only be required.

All Software Validation Plans Encompass the Following:
icon Software Validation GAP Analysis

Software Validation GAP Analysis

Before any Validation Plan is instituted, a complete GAP Analysis is performed on the Software System. The results of this analysis is documented and utilized for the validation plan moving forward.
icon Software Validation Protocol (Validation Plan)

Software Validation Protocol (Validation Plan)

This document outlines the project deliverables and responsibilities.
icon 21 CFR Part 11 Compliance Analysis

21 CFR Part 11 Compliance Analysis

This document evaluates system applicability/requirements for the use of electronic signature as required by the FDA in 21 CFR, Part 11.
icon Network Diagram

Network Diagram

This required document provides a visual layout of how the system is configured within the Cloud and/or on Premise. It serves to demonstrate that you understand how your system is configured for your implementation. (Note: this diagram may be included as an attachment to the Software Requirements Specification)
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Risk Analysis

This document evaluates application safety and identifies potential hazards, the causes and the effect each hazard has on the application safety and use. Insofar as this is a business system, the risk assessment should focus on the business processes being managed by the system versus a more traditional FMEA risk assessment for software programs which are part of a device and pose direct patient risk. Not all risks will be solely mitigated by the software, some risks are mitigated procedurally.
icon System/Software Requirement Specification

System/Software Requirement Specification

This document details system requirements. However, this is more than just a list of functional requirements. This document should also capture a good description of the various components that make up the system so that there is a clear understanding of what this system involves. The requirements specification also needs to include information around physical hardware requirements, physical software requirements, client user requirements, training requirements, and detail about any customizations or integration with other systems.
icon IQ – Installation Qualification

IQ – Installation Qualification

Installation qualification referred as ‘IQ’, is the process of validating if the supplied software is successfully installed on the specified environment with the specified configurations, and to verify how these installation steps are recorded in the document called ‘Installation Guide’.
icon OQ – Operational Qualification

OQ – Operational Qualification

Operational qualification referred as OQ is the next activity of the software validation process after the successful completion of IQ. This activity includes the tests to be run in order to verify that the software is operationally fit to be deployed to the consumers. Ideally, the key functionalities of the software and business processes are verified as part of this validation process. Operator Training is also performed during execution of this Protocol.
icon  PQ – Performance Qualification

PQ – Performance Qualification

After ensuring successful IQ, OQ completion the next activity in the Validation process is to ensure if the product/software meets the specified Performance aspects under the expected load consistently without causing any bottleneck in the production environment. The key aspect of PQ is to ensure that a software, when installed on the expected system, can handle the live load and meet the expected response time and performs correctly handling concurrent users.
<span>Validation Approach & Implementation Lifecycle</span>

Validation Approach & Implementation Lifecycle

<span>Validation Lifecycle Controls</span>

Validation Lifecycle Controls

<span>Lifecycle Controls Work Streams</span>

Lifecycle Controls Work Streams

Direct Manufacturing Process Validation Inclusions:
Equipment Qualification and Process Validation
icon Validation Plan

Validation Plan

Detailed planning scope and structure associated with production process and software validation, including how to qualify/validate in order to ensure control and compliance regulations.
icon Facilities Layout

Facilities Layout

Detailed mapping of facility equipment layout.
icon Process Master List

Process Master List

List of all processes including Administrative, Manufacturing, and Supplier.
icon Equipment Master List

Equipment Master List

Detailed mapping of facility equipment layout.
icon GQ  - General Qualification

GQ - General Qualification

The intent of this section is to address (at a minimum) employee training, calibration, user requirements, supplier approval, factory acceptance testing, site acceptance testing. Evaluation of Process Risk prior to Installation Qualification (IQ).
icon IQ – Installation Qualification

IQ – Installation Qualification

Documented verification at the time of installation, ensuring that the equipment and equipment related systems comply with the recommendations of the manufacturer as well as the design specifications. This step also ensures that all required utilities and support systems are available and sufficient to ensure proper installation of equipment being qualified.
icon OQ – Operational Qualification

OQ – Operational Qualification

Documented verification that the equipment performs in accordance with the manufacturer's specifications and process requirement extremes (worst case) of the equipment or process capabilities.
icon PQ – Performance Qualification

PQ – Performance Qualification

Documented evidence that a process system performs as intended and that it demonstrates the capability to consistently meet appropriate specification and requirements defined in the protocol. Details the process to be validated and how many the process will be repeated for the validation study. Identifies critical process steps and how they will be challenged. Describes routine and special testing and how/when samples will be taken, labeled, transported and tested.

Validation Process Framework Sample Templates

Our prepackaged Validation Process Framework templates will improve the efficiency of your Regulatory Team. Request our sample templates to learn how.
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Customer Stories
Video Poster

I am very impressed with the total quality management system, which addresses cradle to grave traceability, which is imperative in our business.

Jason Bardaville
Loos & Co.
Video Poster

Our Infor Quality system enabled us to organize ourselves and manage the ISO 13485 certification and validation process. It would have been impossible to achieve without the software.

John Phillips, President
Phillips Precision
Video Poster

Our inspection data entry is 200% faster. We spend much less time on documentation and all other quality processes take 33% less time.

Joe Lendway, Quality Assurance Manager
Top Tool Company