Today, companies and organizations operate in a much more complex environment as far as tracking and reporting on events, activities or items as they occur. This is particularly true in strictly regulated environments such as the development and production of pharmaceuticals, medical devices and food where compliance with current (and future) regulations is also required. It is also true for the production of nuclear materials, their use and disposal, as well as the collection, analysis, monitoring and reporting of environmental samples. To attempt to collect, store and report all of this information without the aid of computers is a daunting / impossible task.

For your tracking, compliance, recording and reporting needs, it is faster, easier and safer to use Matrix Track-IT than develop individual solutions for each separate requirement.The Matrix Track-IT system from Autoscribe is a single, very flexible, software product that allows the exact same program and code to be fully and compliantly configured to meet the precise needs of these different applications without writing any custom code or esoteric scripts. Totally different fields and labels may be created using the uniquely powerful Matrix “OneTime Configuration” tools, so as to support these various applications, all using exactly the same source code. Different localizations and languages are also fully supported.

Matrix Gemini “OneTime Configuration” tools create a unified screen configuration which is immediately available via a LAN, WAN or web browser without the need for custom programming. This allows Matrix Track-IT to provide an identical user experience whether working on a desktop PC or accessing your data remotely via a web browser. Customers can also be allocated secure user names allowing them to track their own work online.

The benefits of this approach over the definition and creation of different custom written  programs to meet these needs are many, but can be summarized as:

·         There is no source code or esoteric basic scripts to create, document and debug and therefore the implementation process is much faster and less expensive.

·         The power of the configuration tools allows for fast iterations of prototype configurations before the final design is accepted for the implementation by the users. Users are encouraged to express their thoughts and findings about each revision of the prototype configuration and therefore users obtain a final design that is more acceptable to them and is seen as more “user friendly”. The final implementation also typically requires minimal training as the system does precisely what the users normally do – ie it follows precisely current working practices. The system also readily facilitates compliance both in terms of audit and versioning and in terms of users following procedures and SOPs that they are mandated to do so.

·         Each installation and application uses the same code and so  support is much easier and less expensive.

·         In both large and small organizations, the IT group or lead user can become very fluent with the software such that they are able to deploy it themselves to meet varied business needs. One software program with many uses! Configuration training takes only 3 days.

·         One validation, many applications with all the compliance and audit trails included to meet the strictest regulations.

·         Data entry can be improved by the optional use of barcodes and scanners.

Matrix Track-IT:

• Simplifies production and laboratory management by tracking any item, batch or sample

• Enhances compliance by improved traceability and accountability by auditing all actions

• Positively identifies the current sample location, owner and change of custody

• Eliminates potential problems caused by loss of or difficulty locating samples

• Barcode Ready

• Facilitates ISO17025, ISO9001, FDA 21CFR11 compliance

• Saves time by automatically allocating tasks and tests to samples as they are registered

• Eliminates errors by allocating a unique identifier to every item, batch or sample

• Provides immediate feedback on item location and work progress

• Enhances available information through standard set of reports e.g. trend of sample turnaround times

• Allows easy upgrade to full LIMS functionality with full protection of entered data
  Web browser and / or Desktop Clients may be used with the system

More specific examples of this type of activity that must be recorded and reported are:

·         Collection, storage and processing of serum samples in human clinical trials.

·         Collection, processing and management, including archiving, of slides, tissues and fluids in pre-clinical pathology studies.

·         Production and control of labels during manufacture of bio-active materials.

·         Management, tracking, locating and consignment of hazardous waste.

·         Tracking, recording and reporting on the location and usage of re-usable containers through a production and test process.

·         Location of retained samples or stability samples and associated records.

·         Finding environmental, tissue or seed samples stored in rooms, fridges and freezers.

For more examples on how Matrix Track-IT has been employed to satisfy different requirements, for different companies, please read on.

Tracking Tissues, Cassettes and Slides in Pre-Clinical Pathology Studies

Matrix Track-IT has been configured to globally manage the inventory of samples in a large, multi-site development program for a major pharmaceutical company. It provides the current location of all tissues and slides in multiple studies across multiple sites. A complete history and chain of custody for each sample is captured and stored. Prior to using Matrix, it was very difficult to locate any specific sample or slide when required by a scientist or pathologist.

Once entered into Matrix, the location and history of each sample is readily available.  Data entry is reduced by the use of barcode labels and scanners located throughout the laboratories. The entire system is validated and operates under GLP guidelines

Managing Stability Sample Inventories

Pharmaceutical companies and food companies must carryout shelf-life studies to support their shelf-life claims. These studies can involve the storage and movement of large numbers of samples from and between temperature controlled chambers. All movements must be audit trailed to clearly state the person completing the move, the time and date of the move and optionally, the reason for the move. Keeping accurate records of placements, pulls and testing is a demanding task without some way to capture and report this information.

Matrix Track-IT can be configured to support this requirement and provide easy access to the location and history for all samples on all studies. It may also be configured to produce “pull lists” of samples that are due for testing during a specific time period.

Tracking Containers

Matrix Track-IT may be configured to track re-usable containers though any production or laboratory process. By allocating a unique identifier to each container and storing information (plant, sampling point, sampling time, container type, etc.) you can ensure that the correct containers are used when collecting the samples, avoiding cross-contamination, mislabeling and incorrect handling. It also provides a fall-back method for sample identification, if a sample label is lost or damaged. Tests may be associated with container type, ensuring that the correct tests are carried out for that type of sample.

Tracking Hazardous Waste

Matrix Track-IT may be used to track, locate and consign any type of waste samples within your organization for compliance with regulatory legislation. Barcodes can be used to register hazardous waste items, check their location and their processing status, all with full chain of custody information.

The registration screen provides a browser for looking–up and assigning the correct hazard codes to a set of samples. Notes specific to a sample or set of samples may be entered and reported. Items ready for consignment may be sorted and located. All changes to entries made into the system are recorded along with time/date and the identity of the user making the change. Records cannot be removed from the database; revisions of each record are retained and are available to report the history of any waste.

Platform for Matrix Track-IT

Matrix software may be deployed as a conventional client server application on your network or with thin clients using Microsoft Terminal Services or Citrix. It may also be deployed using a Microsoft IIS Webserver. Matrix Track-IT operates on Windows® PCs and may be used with either Microsoft SQL Server or Oracle databases. Please contact Autoscribe for specific version and hardware requirements.

Matrix Track-IT is developed and produced in an ISO 9001-2000 certified process and Autoscribe’s QMS has passed the audits of some of the world’s largest companies.