Since 1991 in San Diego, CA, the CEO and founder of PACE has built a specialty in providing high quality document management services to FDA regulated companies. The FDA places a high value on manufacturing biomedical and pharmaceutical products in a controlled and well documented manner. Companies who work with FDA regulated companies in a way that affects the quality documentation for the manufacturing process fall under the same quality system requirements as their customers.
The FDA requires records like Batch Inspections, Validations, Metrology and Calibration records to be maintained for the purpose of audit. These documents often start as wet signature paper documents that may go through several levels of inspection and approval. If the documents are to be managed digitally, it must be done in accordance with CFR21 Part 11, the Electronic Records portion of the FDA’s GMP (Good Manufacturing Practices) requirements. The FDA will audit a business regarding their change management controls, user training documentation, management and tracking of SOP creation, approval and upkeep.
So PACE did we always seem to do. We created a systemic solution to have the most efficient and audit ready process. In the process, we created the earliest version of what would eventually become our business operating software, PACE, an acronym for Performance, Accuracy, Commitment and Engagement. (Queue the swelling music.)
Back in 2007, we had to race to meet some very basic but powerful objectives. We wanted to be able to prove through our automatic recording of operator actions that we were exceeding the quality standards set by the FDA. That system was focused on batch management, SOP management, work instructions management, basic time clock functionality and not much else.
Once the foundation was established, PACE rapidly became the System of Record for most of what happened for our first client, Recordsforce. The product was expanded in both function and capacity as the company grew. We added email, reports, a report server, a portal and a lot more features that each make the product easier to use or more useful.
As the years went by, we saw the development of two products running parallel to each other. The first was BPS, which became what today is called PACE and the second is PACE Data Capture, our document processing software. At the end of 2022, for the first time, the two products will be united under a single brand identity, PACE5.
The buyer of PACE5 has all of the tools needed to operate a document scanning and BPO company. The system manages staff and staff work assignment, job workflow, batch quality, tons of reporting, customer visibility of job status (Portal), customer billing, time clock, and so much more.
*In comes the age of AWS (Amazon Web Services).*
Recently AI has emerged as a viable candidate for automatically classifying and extracting data from images of documents. But this tool, while enormously powerful, is completely useless without a way to manage what’s going into and coming out of the AI engine. PACE5 is designed from the ground up to tell the rest of the story when it comes to automatically processing inbound documents.
AWS has enormous power to read forms and return “key pairs” which are pairs of field headers and field values. AWS doesn’t know which ones you want or why, it just finds them all and brings them to you. What now?
We call it “Zero Touch Processing.” It’s when a document is received and moves through the entire process of being cleaned up, classified and having its required data extracted, formatted and automatically delivered to the desired system, all without a single operator lifting a single finger. That’s Zero Touch!
Business Process Outsourcing is a catchy phrase, but without the right controls in place, it can turn into a nightmare. Don’t stress your staff out with lame software that forces them to remember every detail or something falls through the cracks. Build the intelligence of your business into PACE and let your employees relax. PACE has got it all under control!