EpiMed Streamlines the
Medical Device Development Process for Epicor Kinetic

EpiMed is EpiCenter’s comprehensive life sciences system that provides all of the necessary functionality for various life science requirements such as the medical device development process.  The core of this offering is the Epicor Kinetic system, and as an Authorized Partner of Epicor, EpiCenter has developed EpiMed with the input and collaboration of many of our customers. This system is very scalable and useful for startups as well as established organizations who need to comply with ISO 13485, and/or 21 CFR Part 11.  

The cornerstone of this functionality is Epicor’s extensive traceability and EpiCenter’s efforts at creating an ‘out of the box’ solution for key health sciences requirements.

Each health science organization identifies its procedures, and our job is not to create these for the organization.  This system allows the organization to execute on critical deliverables and address challenges for medical device manufacturers, for instance:

  • Biometric Identification for Critical Transactions – the system requires a fingerprint scan at the time of entering critical data, and the fingerprint scan is validated against the list of authorized users for the given operation.  If the person is validated, they are allowed to enter data.  Their signature can also be captured and compared to their base writing sample.
  • Electronic Device Master Record – since all transactions are electronic, including capturing electronic signatures, we can output a device master record that includes every bit of information about the given product, including component serial numbers, lot numbers, quality plan submissions, certificates of compliance etc.  This electronic device master record is stored on the system permanently and can be regenerated at any time.
  • Case Management & Corrective Actions – as post-shipment cases come up, they are connected to internal or external Corrective Actions, as well as to the root cause analysis and Preventive Actions.  Reporting is available for the Corrective Action process including the ability to write custom reports regarding specific topics or cross-referenced attributes.
  • Master Filling & Packaging – if your organization dispenses products into multiple sized containers and aggregates them into master packs, our extensive units of measure and pack out functionality can generate one or more labels per vial, master pack, case etc., and using barcode or QR codes tracking for components, in process, or end products.
  • Transitioning & Implementation – It is typical for any organization to have gotten started with spreadsheets or other methods of collecting quality data.  EpiCenter provides training and services to migrate data from various sources so that all quality data are together in one system, available for evaluation and analysis at any time.  This can give complete data continuity from the inception of a product, all in one system. EpiCenter also specializes in IOT integrations to test equipment, production devices, or virtually any machine or system in a modern facility.  These integrations can share quality data, production information etc., which decreases or eliminates manual data entry.
  • Validation – If your system is required to be validated, EpiCenter can assist in this process, as well as provide future support for upgrading and revalidating scripts.  The Epicor framework, which EpiMed is based upon,  is excellent for facilitating this process.

Corrective Action

EpiCenter’s Corrective Action process integrates with case management and other quality-related areas of the base Epicor Kinetic system.

Case Entry is the starting point when an end customer sends in a request because of a failure in the field.  That request can follow any number of preset tasks, depending on the nature of the failure.  In some organizations, every case entry is required to generate a Corrective Action, and in others, there can be multiple Corrective Actions per case.  Epicor handles either of these scenarios as a master setting for that organization.

Corrective Actions are entered including root causes and can be tracked for common attributes to minimize duplication of Corrective Actions.  Workstreams are in place to route the Corrective Action to various staff, as well as capture short-term and long-term solutions.

Robust lookup utilities exist to help parse through large numbers of Corrective Actions so an organization can not only effectively manage their processes but present information needed for periodic internal or external audits.

Biometric Authentication

EpiCenter has built a system of fingerprint and signature scanning that captures a staff member’s data, and when they scan at a workstation for a given process, the system compares the scanned fingerprint or signature with the one on file, and approves or denies the transaction.  

This system, using Topaz scanners, can be used by non EpiMed customers who for instance just want to validate fingerprints for system clock in and clock out functionality.  

A permanent record of each scan is kept for future evaluation.

Signature Authentication

EpiCenter’s Topaz integration can be configured just to be used for signature capture.  This is typically used for validating the identity of quality technicians who enter data for quality plans.  It can also be used anywhere signatures are required, such as certificates of compliance or quotations. 

For instance, a product may fail a quality plan, but still, be acceptable to some customers.  Where there is subjective judgment involved, a supervisor can be required to add their signature to the transaction.  When this happens, the signature is compared with the signature on file, and if it matches, it is accepted and becomes a permanent record of that transaction. 

This assists any organization in becoming completely ‘paperless’ which is not only more efficient, but also provides ease of research for any issues discovered after the product leaves the production facility. 

Documentation Management

This feature is EpiCenter’s utilization of Epicor’s Document Management capability, as well as IDC (Intelligent Data Capture).  In installations where there is a significant amount of outside data (test reports, certificates of compliance, etc) and it is necessary to pull this data into Epicor so it can be evaluated and used for actionable production initiatives, we suggest using IDC.

For instance, perhaps an organization has years of metallurgical test results for castings used in producing implants.  The physical data for each lot could be critical in identifying issues in the field, years after manufacture.

IDC is a system that ‘reads’ the existing record and can have heuristic routines set up to apply logic to the process of ‘reading’ the document.  It’s best if the documents are formatted, and when they are, the system can search for keywords like ‘element’ and then look to the right of that word, and ‘read’ the next word, and compare that word to a database of element names. If there is an exact ‘hit’, then a record can be written related to this document, with its accompanying values.  If there isn’t a direct ‘hit’ but there is an 80% match, the word can be presented to a person for final determination.  The process of reading thousands of pages of data and entering it into the system is significantly faster than doing it manually, and can greatly help not only with historical data but also posting new data from various sources.  By validating the data against acceptable values, and building logic tests, an organization can develop very specific and reliable routines for reading data.

In cases where the information is not formatted, such as this document, the system scans and indexes every word, and the system can search every document for that word.  This may not always be an optimal solution, but it’s still easier than manually thumbing through thousands of documents. 

 

EpiCenter is very proud to be able to provide these strategic products aimed at the health sciences industry, to best eliminate cumbersome systems, and most efficiently help our health sciences clients with very efficient and flexible solutions. 

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EpiMed Information Guide

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