But with challenge comes opportunity, and a number of software providers have stepped into the breach to offer digital documentation solutions that can be more accurate, more up-to-date and even cheaper than the paper-based systems which many manufacturers have still been relying upon for some or all of their documentation needs.
Records, records and more records
FDA Part 111 calls for a slew of records to ensure that the dietary supplements manufactured at a given location or under the authority of a given brand holder consistently meets the standards for identity, purity, strength and composition and is manufactured, held and packaged in such a way as to avoid adulteration. Proving that is the case calls for standard operation procedures, product specifications, master manufacturing records, batch records, testing records (both for incoming and outgoing material), training records, cleaning and maintenance records and so forth. In many cases these records need to properly reference one another, to ensure, for example, that a blend for a given batch of product was made in a blender that was verified to have been properly cleaned, or that a given batch of product was made with the latest version of manufacturing instructions.
Matching these records up, properly filing them and dotting all the i’s and crossing all the t’s takes time and money. Calculating how much is spent on that activity can inform the decision of whether to take the plunge into digital documentation said Dennis Ferrarelli, manager of quality and food safety for ss software provider N2N Global of Longwood, FL.
“I don’t think the dietary supplement industry knows there is a solution like ours available,” Ferrarelli told NutraIngredients-USA. Ferrarelli’s company is one of several offering integrated solutions that can replace a company’s phalanx of forms and clipboards.
“There is an operation savings component. I have a customer who before using our system was generating 5,000 pieces of paper a week. The effort of generating that paper, filing that paper, potentially retrieving that paper in an audit, that is a very non-value added activity. You are not going to pay someone to take a five-hour cigarette break, but you’ll pay someone five hours to file paper,” he said.
Patchwork of data collection systems
Dietary supplement companies are all over the map in terms of their data gathering practices said William Pape, executive vice president and cofounder of TraceGains, a document management firm based in Westminster, CO.
“It they are using an automated system to gather data at various points we have very simple tools to bring that data into our system because we believe you should only enter data once,” Pape said. “If you are doing things on the back of an envelope or on paper forms we can give you the appropriate electronic form to use and the data will go straight in.”
Richard Soltero, president of Pharma Directions and InstantGMP (based in Cary, NC) concurred, saying, “while you would think all those companies are computer literate it is not always true in the dietary supplement world.”
InstantGMP’s system, called InstantGMP MES, starts from a basis of forms and policies, offering in addition to electronic batch records and storage a series of prewritten documents that can be tailored to customers’ needs.
“We have about 90 SOPs and procedures that actually form the basis of meeting the requirements for GMP compliance,” Soltero said. InstantGMP’s system can access the correct forms automatically from the files when data enters the system, he said. Among the SOPs the system provides are prodcedures relating to complaints, holding of materials and labels, storage, records retention and distribution and others.
Better data evaluation
In addition to cost savings and increased data entry accuracy, integrated documentation systems can help companies better evaluate and use the data they do collect, Soltero said.
“The data in many of these companies are highly siloed—receiving doesn’t talk to QA testing who doesn’t talk to the factory floor. And nobody is talking to purchasing,” Pape said. TraceGains bases its system on a manufacturing flow-through model, mapping attributes of incoming material and following those lots through the manufacturing process and out into the field. Is one particular supplier, or perhaps material originating from one facility from one supplier the source of most of your headaches? Pape said TraceGain’s system could help a company more easily make that determination.
“What we do is take that data and provide transparency so the whole company can look at the supplier and take a 360 degree view on evaluating that supplier on more than price and on-time delivery,” Pape said.
Another place that these systems can save time and money and provide piece of mind is on the back end, where the quality control staff is trying to make verify that what is going out the door is what the company believes it to be.
“The other piece that makes it so much more efficient is the area of quality assurance,” said Soltero of InstantGMP.
“On a paper-based system a person has to go around to make sure that all the paper is correct, and that it all matches up. In our system quality is done in real time. In our system only correct information can make it all the way through the system so quality has very little they need to do at the end,” he said.