Design Control Templates
The Design Control Toolkit offers 21 interrelated design control templates, standard operating procedures and forms ready for customization. The included document forms are provided in Microsoft Word® and Microsoft Excel® formats. Other materials provided include a step-by-step guide for customizing and utilizing these procedures and 8 hours of Quality Compliance Consulting (QCC) to help you implement your design control.
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Design Control Toolkit Contents
The design control templates contained in the Design Control Toolkit have been specifically created to meet the FDA design control regulations outlined in 21 CFR 820.30. It has been successfully customized and implemented by a variety of device companies, both start-ups and larger organizations. Furthermore, it is ready to be uploaded into the MasterControl quality management software (QMS) suite to provide a fully automated design control program, which will help you bring high-quality medical products to market faster.
The Design Control Toolkit includes the following:
- SOP: Product Development Plan SOP-0001
- SOP: Design Control SOP-0002
- SOP: Change Control SOP-0003
- SOP: Risk Management SOP-0004
- SOP: Design Review SOP-0005
- SOP: Verification and Validation SOP-0006
- SOP: DHF SOP-0007
- SOP: DMR SOP-0008
- FORM: Change Control FRM-0003
- FORM: Phase I Design Review FRM-0005A
- FORM: Phase II Design Review FRM-0005B
- FORM: Phase III Design Review FRM-0005C
- FORM: Phase IV Design Review FRM-0005D
- FORM: Phase V Design Review FRM-0005E
- FORM: Risk Assessment FRM-0004
- FORM: Traceability Matrix FRM-0002
- FORM: DFMEA
- TEMPLATE: Project Charter
- TEMPLATE: Risk Management Plan
- TEMPLATE: Design Transfer PLN-0001
- TEMPLATE: Project Design Plan
Learn More About How to Benefit from Your Design Control Toolkit
To learn more about MasterControl’s Design Control Toolkit, or to discuss how the kit’s design control templates can assist your organization’s quality management, contact a MasterControl representative.
The QMS Provider for the FDA
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
Need more information?
To learn more about MasterControl's software systems, please contact a MasterControl representative.
