In the wake of the numerous compounding disasters of the past decade, coupled with the market pressures created by local state boards of Pharmacy and FDA compounding enforcement activities which have increased exponentially. Large fines, censure, and license revocations have become commonplace. With this increasing focus on this area of practice and the narrow tolerance of these agencies for any gaps in activities, recordkeeping, or documentation, how can you be sure your operation is in FULL compliance with all these developments?

In the past, the patient profile, your prescription logs, and finance records were more than enough to satisfy any regulatory inspector. This is no longer the case. Migration to computerized software made pharmacy practice more efficient, able to handle greater numbers of patients, and reduced some of the paperwork burdens on the dispensing pharmacist, and the business owner. What followed in the marketplace was simply automated extensions of the “pharmacist’s typewriter,” and true data management of this critical information was largely ignored.

As computers and software became more accessible and less costly, many software programs became available for the simple processing of prescriptions, including compounded prescription formulations. However, the accepted standard was a data system to capture the most essential data to satisfy the local State BOP, and to generate a label & a payment receipt, (profile-label-bill) with as few key-stokes as possible. What was and is, available as “compounding software” simply continues to follow that general formula.

Compounding Process Gardian™ (CPG™) is not simply “Compounding Software” to fill compounded prescription orders, but a Fully Integrated complete regulatory compliance platform which accounts, tracks, and assists in the complete & proper documentation of all of the elements necessary to fully comply with every facet of the compounding production process.

Traditionally developed compounding Software products are only automated systems which track ingredients and supplies and generate lists of chemicals and quantities with very basic directions taking the compounder through the steps to assemble the preparation. Their focus is to create what they consider to be, the minimum documentation and prescription label, as well as to generate a “re-order shopping list” for the pharmaceutical ingredient supplier to assemble a compounded prescription. These systems fall short on all other practical, operational, and regulatory aspects which comprise a safe and properly compounded finished preparation. Most times you do not realize these gaps in your software and general operational process until you have an inspector in your location asking tough questions!

If your software is not assisting, you in tracking and documenting the entire life cycle of your compounding operation you could be leaving your operation vulnerable to regulatory gaps or safety voids. Tying together the facility management, environmental monitoring, employee training & qualification, equipment calibration and business management in one place is invaluable not only as management tool, but as a solid risk avoidance platform.

CPG™ can do the whole job of documentation and clearly prove you have completed the process correctly using one Software Platform saving you countless hours of record keeping and requiring multiple pieces of software to stay within compliance.

All of your required data is centralized onto one dashboard and is visible during the entire process and retrievable with a few keystrokes to any web-enabled device. For those who are responsible for multiple compounding sites or are not tethered to an office, fully customizable management dashboards are available to allow real-time tracking of key-performance-indicators (KPI) to almost any mobile device.

During a regulatory audit or accreditation visit, when time and patience is short, and stress at its peak, CPG™’s ability to electronically allow instant access not only to key production data, but also supportive & reference documents (i.e., master formulas, batch records, API certificates-of-analysis, employee training records, equipment manuals, calibration records and environmental sampling data) reducing the inspection’s chaos. No more running around retrieving records from multiple binders and making numerous photocopies and most of all distracting and interfering with the efficient daily operation of your facility (not to mention the lost time re-filing all those documents), and no one wants to consider the misfiling or loss of some of those required records in the shuffle!