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Environmental Manager

When it comes to managingregulatory documents suchas product labels, bills oflading, and certificates of

analysis (COA), virtually all manu-facturers in the chemical process in-dustries (CPI) face the same challenge

— getting the right information intothe right document formats for everyshipment. This challenge becomesmore complicated when you ship tocustomers with unique labeling andreporting requirements. This articleexamines why regulatory documentmanagement is such a challenge, andshows how to take that challenge andmake it an opportunity.

Technology and human errorThe challenges of regulatory document

management are typically rooted inthe type of technology you use to runyour business. Many chemical manu-facturers start out using multiple soft-ware tools, such as spreadsheets andbasic accounting systems. As businessgrows, more systems are added — anew laboratory management system,an inventory management systemand so on. A separate system for regu-latory reporting and labeling is oftenadded to the mix as well.

For most companies, that regulatoryreporting “system” is nothing morethan a series of word processing docu-ments. That means you have to rely on

an individual or team within yourcompany to manage this manualprocess. With your data scatteredacross multiple systems, the personassigned to this task must search sev-eral locations for the formula, batch,quality assurance (QA) and qual-

ity control (QC) information for eachshipment. Then, because different cus-tomers may have different documentspecifications for the same products,all of these data must be cross refer-ences with the customer files. Finally,he or she has to select the proper doc-ument format and correctly enter theinformation. Meanwhile, if more thanone person is involved with this task,the level of complexity is even higher.

Beyond the obvious bottleneck, youalso face the possibility of human

error every time your facility preparesa new shipment. There is always achance that someone will choose thewrong form, make a formatting mis-take, or enter incorrect QC and for-mulation values from time to time.

 And it’s quite likely that the incorrectinformation will then be passed on toyour customers. Making matters evenworse is the fact that returned ship-ments will reenter your bottleneck,where similar mistakes can happenagain. In this scenario, it won’t takelong for your customers to start look-ing at your competition for a more de-pendable supplier.

So the question remains: How can you

ensure your regulatory documentationalways has the right data in the rightformats? The trick is to integrate all ofyour business processes — formulation,sales, purchasing, inventory, produc-tion, QA and QC, lot tracking, account-ing and regulatory reporting — in onesoftware system. Integrated enterpriseresource planning (ERP) software doesthis, giving you one location to manageall your data. Using one system meansthere’s no need to reenter information.It also gives you greater control over

your processes and reduces the oppor-tunities for human error.

Configuring it to your needsWell-designed ERP software helpsyou get the right data into the rightdocument formats by allowing you toconfigure regulatory document tem-plates. The term configure means youcan adapt the system to your businesswithout altering the basic program-ming code. The benefits of configu-rable templates include cost efficiency,quick installation, and longterm easeof maintenance.

Modern ERP systems can even use

Solids Processing

Software helps ensure that you always

have the right data in the right format

Jay DeakinsDeacom, Inc.

 An integratedERP system automatically

populates the proper documenttemplate, such as a bill of lading,

with the proper data so the system doesthe data work – not your employees

Foolproofing

RegulatoryDocumentGeneration

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the familiar functions of MicrosoftWord to lessen the learning curve ofdocument configuration. Using the

data from your ERP system throughthe Word application, you can insertand arrange data fields, logos, andother characters according to your ownspecifications to configure a documenttemplate for each regulatory form youuse. This list could include productlabels, COAs, Material Safety DataSheets (MSDS), packing lists, bills oflading and so on. Depending on thecomplexity of your regulatory reportingneeds, you could configure product- andcustomer-specific templates, as well.

The configuration of regulatorydocument templates ultimately sim-plifies matters on your shipping dock.When your employees print the regu-latory documentation for a shipment,whether it’s going to Cleveland, Can-ada, or Katmandu, the system wouldautomatically populate the propertemplate with the proper data. Thesystem — not the individual — doesthe data work.

Simplifying the human role

While integrated ERP software elimi-nates redundant data entry, a humanstill has to enter QC data into the sys-tem as you run tests. This is a majorproblem area when using multiplesystems, because it’s very difficult toapply process controls across severalapplications. But with one point of datacontrol, you can establish rules that re-strict data entry.

Setting QC reporting ranges is oneexample. If you set the reporting rangefor the pH of a product at 8.6 to 9.2,and an employee accidentally enters88 instead of 8.8, the system would au-tomatically stop the process. The em-

ployee would be prompted to fix his orher mistake before moving on. If thisdatum was entered into a separate sys-

tem, you might not be able to catch theerror. Process controls such as QC re-porting ranges are the only way to en-sure your data are always accurate.

 A science, not a science projectWhether you make one product forone customer or 1,000 products for

1,000 customers, regulatory reportingis an important part of your business.It gets your products where they’regoing, keeps you in good standing with

regulatory agencies, and provides yourcustomers with the data they need torun their operations effectively. Byusing ERP software that integratesconfigurable regulatory documenttemplates with all your business pro-cesses in one system, you can turn thechallenge of regulatory reporting intoan opportunity to establish your com-pany as a reliable supplier. ■

 Edited by Rebekkah Marshall

 AuthorJay Deakins is the president

of Deacom, Inc. (950 West Val-ley Rd., Suite 3000, Wayne, PA19087; Phone: 610-971-2278;Email: info@deacom.net), theproducer of an integrated ac-counting and ERP softwaresystem for specialty chemi-cal manufacturers. Prior toestablishing Deacom, Inc., hefounded and served as presi-dent of Sun and Earth Co., a

manufacturer of all-natural cleaning products.

CHEMICAL ENGINEERING WWW.CHE.COM AUGUST 2010 41

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Fully-integrated ERP software provides the process controls necessary to preventdata entry errors by halting users during the QC process. Consider, for example, if avalue falls outside a predefined reporting range. Here, failed tests are highlighted foreasy identification