Since 1991 in San Diego, CA, the CEO and founder of Recordsforce 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. That includes Recordsforce.
As a document scanning and cloud-based hosting company, Recordsforce has successfully grown their business helping biotech and pharma companies eliminate the paper records generated as part of the quality documentation process. 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. Our company has the experience and skills to handle these types of documents for 20 years now, but that was not always the case.
After six years of growth and the addition of multiple biotech clients, Recordsforce was on its way to success. However, in 2007 Recordsforce received the results of a customer quality audit that were not favorable. This customer, a biopharmaceutical company, was utilizing Recordsforce for their quality record management. As part of their quality system they performed an audit of our quality system and the results were unexpected and disappointing to say the least.
After years of successful audits, this audit produced a host of findings regarding our change management controls, our user training documentation, our management and tracking of SOP creation, approval and upkeep. In general, it felt like we went from being a great provider of FDA compliant services to barely hanging on to our largest biotech client. We had to act!
The result of the audit was an agreement between Recordsforce and the client that if we could address the findings of the audit and resolve them over the next six months, we could avoid the client opening up our contract to other suppliers. We had a choice to make.
Rather than put a band aid on our quality management system, we did what we always seem to do. We created a systemic solution to our systemic problem. 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.)
Our industry is not well served. We aren’t a big industry, so software developers tend to look for bigger opportunities elsewhere. As a result, when we went shopping for software to help us manage our company there just weren’t any viable options.
We selected and purchased a software product and over a year of banging our heads against the wall, determined that it was not going to be able to help us with running Recordsforce. We decided that if we wanted the best system to manage our business and to meet our new quality system requirements, we would have to make it ourselves. The product, originally just called BPS (Be Productive Systems), was the first step in what we today call PACE. But BPS had many of the same features we see in PACE.
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, BPS rapidly became the System of Record for most of what happened at 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, Recordsforce saw the development of two products running parallel to each other. The first was BPS, which became what today is called PACE4 and the second is MadWhack, 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. The only software we still use outside of PACE are scanning applications for our different scanners and our cloud based document hosting and workflow systems called Recordsforce Cloud.
*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!