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“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

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Business Partner Compatibility Certification Criteria

  • Review of manufacturer and their practices.
  • Review revision history of solution for upward and backward compatibility.
  • “In-house Certification” must be shipped to enLabel in accordance with enLabel Certification Program policies.
  • “At-Partner Certification” requires an enLabel Certification Technician to go on-site at Business Partner’s facility to perform enLabel Certification. All travel and approved out of pocket expenses for the enLabel Certification Technician will be invoiced to the Solution Business Partner under a separate cover.
  • Certification of the solution’s functionality, memory management, connectivity, programmability, and performance in various applications.
  • Evaluation of the solution with application software for compatibility with open architecture standards including ease of operations and review of documentation.
  • Evaluate Total Cost of Ownership including MTBF (Mean Time Between Failures), repair/replacement costs and cost of consumables.

Membership Requirements

  1. Business Partner Applicant must complete and submit the Business Partner Certification Program Membership Application with an Annual Membership fee of $395.00.
  2. For each solution product model series, registration fee is $1,500.00 plus $295.00 for each model type to be evaluated within this model series for base functional compatibility. For additional feature and option computability certification, enLabel will provide an a la carte configuration testing form with associated fees for the Business Partner to select from for advance testing for compatibility. The features and options will be based on the model specifications and brochures submitted by the Business Partner as part of the registration process.
  3. The Business Partner Applicant is responsible for all shipping and handling charges (including Shipping Insurance if chosen) to and from enLabel for each solution submitted for enLabel Certification. Whether the solution submitted for enLabel Certification passes or fails certification, the Business Partner is responsible for all Certification fees and shipping and handling charges.
  4. If the Business Partner’s product is visually found to be damaged upon receipt at enLabel due to and not limited to Business Partner packing and /or shipping and handling; equipment will be returned to the Business Partner at the Business Partner’s expense and the $295.00 Certification fee will not be applied.
  5. Should there be any changes to, and not limited to, any component, function, or documentation of an enLabel Certified Solution, that newer model must be submitted for re-certification. The fees explained in item 2 apply.

Register for the enLabel Business Partner Certification program

Business Partners interested in the enLabel Certification Program should register their product(s) by completing the Business Partner Certification Program Membership Application or by contacting enLabel at 866-536-5223. Once we receive your Registration Form the enLabel Certification Director will contact you to schedule certification.

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

 

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