What Is Regulatory Compliance?

The best route to understanding what regulatory compliance means is to go the root of the expression, which is clear. Compliance is described as a state of being in accordance with set regulations. So, regulatory compliance is simple -it is being compliant with regulations. Let us explore what kind of compliance is required, and what regulation are we talking about.

Regulatory compliance is an ocean:

In a broad sense, regulatory compliance is something whose depths can perhaps never be fathomed. This is so because everything -meaning quite literally everything from a pin to an airplane -needs some or another kind of compliance. Any product, from the smallest to the biggest, has to be compliant with regulatory requirements. What is it that makes regulatory compliance such a big thing, who frames rules and laws relating to regulation, and why is it so important?

Why is regulation needed?

This is as simple as why rules are needed for governing people. Every product from every field in the physical world, to quote the example given above again, from pin to an airplane, is manufactured and finessed according to set standards. These standards are needed because in their absence, there is no such thing as science in them. Science is all about exactness, logic and predictability.

In the absence of regulatory compliance, this very foundation is shaken. In other words, there is no product without regulatory compliance. All products have to go through demonstrable, deducible and reproducible processes. This is what makes them actual products. Or else, they would be some kind of spiritual experiment that is left to the individual to experience.

Regulation is at the heart of products and processes:

Any product that is manufactured, no matter to which field it belongs, has to undergo a clearly demonstrable process. The process has to be objective, and it must be open to changes and refutations. Only a product that convincingly demonstrates that it is capable of producing its desired effect time and again in any situation and at any point of time qualifies to be a process-oriented product. Regulations are all about making setting out specifications for these.

Further, if a product is to demonstrate its core quality, it has to also ensure that it is safe within prescribed limits. Who sets these prescribed limits? It is regulatory authorities again. So, regulatory compliance is all about ensuring that a product is just what it is and that it serves its intended use within set safety parameters.

Regulatory compliance and non-manufactured products:

Compliance is thus an area that is as vast as it is exact. Respective regulatory bodies exist in different countries at different levels to ensure that anything that is produced meets regulatory compliance standards. Having said this, we have to bear in mind that only manufactured products are subject to these hairsplitting, high-definition regulations. For instance, rice is produced, but is not manufactured.

Safety and intended use are the prime factors:

This is different from the case of say, medicines. All the processes, right from the ingredient stage, are precise and scientific. This is where we have to understand how regulatory compliance works. Eventually, the aim is to ascertain and ensure safety and intended use. Compliance is also needed to make sure that organizations making products are come out with safe products.

Regulatory Compliance – The Art of Being Prepared

Early in life we realize it’s important to be prepared. As students, we listen to lectures so we’re ready if a teacher calls on us. While building careers, we keep resumes updated in case opportunity knocks. As professionals, we listen to clients’ needs and recommend solutions, hoping to solve problems and possibly make a sale. We know the best safeguard against punitive action for noncompliance is to be prepared. So why do we typically find ourselves in a panic when we learn our companies are about to be audited or a court has subpoenaed our records?

In the paper-based world of yesteryear, producing documents quickly on demand was complicated, with damaged, destroyed, or unreadable files due to fire, water leaks, humidity, illegible writing, or deteriorated microfiche. Search was cumbersome – for businesses, but also for auditors. In the digital age, where enforcement is commonplace and penalties severe, there are fewer valid excuses for non-compliance. Most business information today is stored electronically, making it discoverable. Yet many companies still push the panic button when an audit arises. Why? They lack two things:

Central, searchable access to all of their business information; Electronic enforcement of the governance policies they’ve put in place. Simply stated, without enterprise content management (ECM), they’re not optimizing the technology they already own. They’re not prepared.

If you were audited or subpoenaed tomorrow, could you respond without interrupting services or core operations? Would you find yourself frenetically pulling reports and comparing information from disparate applications and paper files? If you don’t have ECM, now is the time to get prepared by leveraging the technologies you own and bringing scattered business information under one umbrella where it’s accessible, searchable, and easy to manage. Don’t let compliance demands bring your business down like a house of cards. Learn how to face the challenge with confidence.

Ensure privacy and security of customer information

Keeping documents secure – yet accessible when they’re needed – is tricky. Even digital files are challenging if you must search through multiple software applications, voice messages, and emails to find information. ECM gives you control over who views, annotates, or acts on files, ensuring instant, appropriate access. By capturing all of your documents, images, and messages electronically and integrating those systems with browser-based ECM, authorized persons can access everything they need, wherever they are and whenever they need it, with a few mouse clicks.

ECM provides a single point of access and a searchable repository for everything you capture digitally. Rules-based access lets you enact privacy, security, and accountability measures on every document that contains a person’s identifiable information. Access is granted based on user name, job role, or other personal identifiers. Sensitive information buried in email, scanned papers, faxes, voicemail, or legacy and business applications is secure. Digital trails of file interactions provide unquestionable proof of compliance with the rules you set in place.

Manage records effectively and produce records on request

Records Information Management (RIM) professionals have big burdens to shoulder. Mergers, acquisitions, and downsizings add to the records management challenge. Meticulous planning and exhaustive oversight mitigate risk, but it’s tough in a mixed-media world.

ECM, especially when it contains business process management (BPM) capabilities, streamlines and regulates the process of data collection and information management. You can:

Establish standards for data collection, ensuring information on forms is consistent and complete; Index files thoroughly, guaranteeing they’re found when needed; Guarantee business information is secure, viewable and actionable only to those with permission; Ensure against document alteration; and Produce clear digital trails of file interaction. BPM – used to drive routine processes forward automatically, and a vital part of a true content management suite – further facilitates records management, letting you:

Set rules to ensure routine processes are managed consistently and on time; Extract data from multiple systems into one for more comprehensive and easier reporting; and Gain insight into business processes that leads to procedural improvements and better information governance. Regulatory agencies expect businesses to keep accurate records, handle information securely, and document business interactions thoroughly. ECM addresses all three, streamlining information collection, security, and reporting from multiple systems. ECM and BPM give RIM professionals the tools they need to manage information effectively and securely, every time.

Automate compliance procedures

BPM is a compliance enabler. Just as ECM tracks every interaction with stored files, BPM traces every aspect of the processes that involve them. A single file may be accessed to update customer information, pull information for an invoice, record when payment is made, and myriad other transactions. BPM records every movement, approval, signature, and more, noting when each occurred, what action took place, and by whom. No need to rely on manual records being correct. BPM tells it how it is.

Joe McKendrick’s excellent article called To BPM or Not to BPM? That’s the Question for 2010, which appeared in the September issue of Insurance Networking News, quotes Celent senior analyst Donald Light discussing BPM and its business benefits. He defines BPM as “a solution set that enables insurance companies to design processes that may be people-to-people, people-to-system or systemto- system in nature; to maintain a repository of those processes; and to put those processes into operation and have them executed in the normal flow of working operations.” Clearly, the benefit extends beyond insurers. The statement summarizes the business value of BPM to any organization that’s subject to regulatory compliance and potential audits: the ability to track every digital file interaction, whether it’s initiated by individuals or follows processes that were put in place.

Automate record retention

If you’re required to comply with HIPAA, Sarbanes-Oxley, SEC regulations, Open Records, Right-to-Know, FERPA, or other rules, record retention will eventually rear its head. Timely record disposal is the sibling of appropriate retention, and each is critical for compliance. By integrating ECM and BPM with all of your business software applications and establishing electronic rules that reflect your internal governance policies, you can:

Migrate files automatically to alternative storage when they exit the active business cycle; Ensure final copies of documents are archived; Schedule files to be destroyed in accordance with your business rules and current regulations; Set alerts for manual review of files scheduled to be migrated or destroyed; and Remove the potential for human error in records management. Rules-based access and processing ensures files are created, managed, and disposed of consistently, eliminating human errors and lost files.

Enable self service

Most people know how to find what they want on the Internet. ECM extends this capability to your records. Integration with your company website or portal lets you make records available securely and appropriately. Seekers gain control over search, saving staff thousands of hours in search, phone calls, and frustration, without compromising document security. Access is expedited internally and for the public.

Enact disaster recovery

Whether you face a natural disaster such as a fire, flood, or earthquake, a seasonal epidemic, or chaos from mergers, acquisitions, downsizing, or turnover, records still have to be kept intact and discoverable. With ECM, you have a centralized, tamper-proof repository:

Archived information is accurate and complete; Regular backup copies of documents are made automatically; Documents and the tasks that revolve around them remain accessible via a Web browser 24/7, ensuring business continuity even in challenging circumstances; Audits, subpoenas, and other demands are met, even when disaster strikes. Getting started: it’s only as difficult as you make it You don’t have to be a technology expert to get started with ECM. A plethora of valuable information is available on the Web, helping you to identify reputable vendors and products. Qualified consultants abound in nearly every industry. Top vendors offer specialized services to help with document and process analysis, workflow design, and address other needs, ensuring your rules reflect the information governance policies you set in place. If you scout carefully, you’ll find cost-effective solutions that match every budget size and need.

An old African proverb relates well to ECM implementations, stating, “It isn’t because it is hard that one doesn’t dare, but since one doesn’t dare, it becomes hard.” You wouldn’t have become the professional that you are if you hadn’t taken the steps to be prepared. Don’t let your business cave in because you’re neglecting to take the final steps. With ECM and BPM, you’ll be prepared for every challenge your business faces – now, and in the future.