“Labeling and packaging issues are the cause of 33 percent of medication errors, including 30 percent of fatalities.”
Institute of Medicine of the National Academies

Business Partner Certification Program Membership Application

Please complete this application form in detail. Not all questions may apply; however, questions with an asterisk (*) are required. Please provide as much information as possible to expedite processing. Feel free to use additional documentation if necessary.

All information entered is confidential and will only be used for evaluation of enLabel Business Partner Certification Program eligibility.

Applicant Information

*Contact Name:

*Job Title:

*Company:

*Address:

*City:

*State/Province:

*Zip/Postal Code:

*Country:

*Telephone:
(ie, 5083394928)

Fax:
(ie, 5083392257)

*E-Mail:

Corporate website:

Solution Information

*Types of solutions/services your company offers:

*Number of Model Series for Certification:

*Total Number of unique models within each model series for certification:

*List all Model Series/Model Number(s):

1. 2. 3.

*No of days solution can be at enLabel for certification

Applicant Overview

Annual Sales:

million

No. Employees:

Yrs In Business:

D&B Rating:

ISO Certified:

Yes No (If yes, please provide a copy of ISO Certification)

Other Certifications:
(incl. cert # & expiration date)

Expires

Other Sites:
(incl. address, city, state & zip)

Organization & Quality Management System

Does your company have the following:

Quality Policy:

Yes No If yes, name

Continuous Improvement Program:

Yes No

Quality Mgmt using metrics to evaluate & improve:

Yes No

Records of employees education, training, skills & experience (incl programmers & developers):

Yes No

Employee training records document procedure title, number & rev level or release date:

Yes No If no, explain

Job descriptions for key quality positions:

Yes No

Internal audit program & defined audit schedule:

Yes No If yes, frequency

Records showing planned internal quality audits:

Yes No

Corrective actions are completed as needed:

Yes No

Internal audit program incl follow-up & closure:

Yes No

Sub-contractors for hardware develop or mfg:

Yes No If yes, describe

Method of subcontractor selection:

Subcontractors qualifications & record maintenance:

Technical & quality requirements in orders placed:

Subcontractor selection & product acceptance method:

System Development/ Design Controls/ Specifications/ Testing

Has your company defined & documented the following:

Methodology for hardware development life cycle:

Yes No If yes, doc name & key elements

Methodology for solution development life cycle:

Yes No If yes, doc name & key elements

Design process testable & traceable to reqs:

Yes No

Test strategies at each level of development:

Yes No

Are the following documents (or equivalent) prepared/approved and available for review:

User requirements specifications:

Yes No

Functional specifications:

Yes No

Hardware design specifications:

Yes No

Software test specifications:

Yes No

Support

Support Phone:

# Support Techs:

Tech Support Sites:

Prod. ships from:

Days - order to ship:

Return policy:

Are manuals readily available on the web:

Yes No

Is there a knowledge database available:

Yes No

Do you offer onsite support:

Yes No

Do you offer support/maintenance contracts:

Yes No No If yes, terms

Describe fault reporting / defect tracking process:

Fault reporting linked to change control & CAPA:

Yes No If yes, explain

How are corrective actions communicated internally & externally:

I authorize the verification of the information provided on this application.

Compliance Expertise FDA 21 CFR Part 11, EU MDD, OSHA, DOT, GMP, and UDI

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