Regulatory Compliance

Regulatory Compliance

In all business operations regulatory compliance has a huge impact. Companies spend a lot of time and money in meeting regulatory compliances but a single flaw in their systems can have huge repercussions and might call for huge fines. In order to be compliant, companies must have the appropriate technology solutions that automate processes, ensure security and perform other tasks required for regulatory compliance. The most important asset of your business, your documents, are usually the foremost assets that are scrutinized by regulatory agencies for compliance. Non availability of documents and non conformance to regulatory document lifecycle requirements can result in huge fines and regulatory sanctions. LuitBiz DMS is an excellent document management system that helps organizations minimize document related risks and ensure regulatory compliance. LuitBiz DMS helps organizations meet the regulatory compliances with its following features:

  • Strong security controls to safeguard documents, records & data
  • Document deletion & retention management system to meet compliance requirements
  • Version control feature to maintain document life cycle
  • Workflow to govern creation, review and approval process
  • Complete audit reports of all actions within the repository
  • Document indexing for document categorization and easy retrieval
  • Simple and flexible for user convenience with advanced document retrieval functionalities

GDPR Compliance

Required By: All Companies that collect data from citizens in European Union (EU) countries will need to comply with GDPR rules for protecting customer data by May 25, 2018.

GDPR specifies the roles, processes and technologies organizations must have in place to ensure the personal data of EU residents is secure, accessible, is used appropriately and with consent. Most companies believe it’s just about personal data protection and tend to forget the most important aspect where personal data is stored – DOCUMENTS. We have tried to answer a few questions on how LuitBiz DMS is designed to help companies meet GDPR requirements for document protection including document data protection by design, document data minimization, Right to be forgotten, document transfer and portability, managing consent, breach notification, integrity and availability of documents and accountability log with audit trails for all data consents, requests and remedial actions.

FDA Compliance

Required By: Food and drug manufacturers, traders, wholesalers, sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures in clinical investigations of medical products to comply with 21 CFR part 11.

Food and Drugs Administration is one of the most important watchdogs in medical product manufacturing. Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions. It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data. If your company is looking to make the FDA 21 CFR Part 11 compliance shift consider the Part-11 compliant solution that LuitBiz DMS has to offer.

GMP Compliance

Required By: Pharmaceutical and drug companies need to comply with the Good Automated Manufacturing Practice (GMP) regulations that describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product and need to be managed carefully.

The technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE) known as the GAMP COP (community of practice) aims to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. They have published the GAMP regulations that outline the procedures that need to be undertaken to maintain highest quality of drugs. The process involves a hierarchical document system organized into 4 levels. LuitBiz DMS helps pharmaceutical and drug companies meet these requirements.

HIPAA Compliance

Required By: According to The Health Insurance Portability and Accountability ACT (HIPAA), if you are belong to the category of “covered entities” or “business associates,” and you handle “protected health information (PHI),” you and your business are required to be HIPAA-compliant. In other words, employers and all healthcare providers that transmit employee/ patient information electronically for claims, benefit eligibility, referral authorizations, etc. need to be HIPAA compliant.

Any information included in a medical record that can identify an individual and was created and used while providing health care (such as diagnosis or treatment) falls under the category of protected health information (PHI). This also includes any conversations a patient has with a physician or nurse about his or her treatment, billing records and medical information in the patient’s health insurance company’s database. Most people have misconceptions about how a document management system can help in ensuring HIPAA compliance. We have tried to explain how LuitBiz DMS can help you become HIPAA compliant.

ISO 9001 Compliance

Required By: All companies providing products / services to customers need to comply with ISO 9001 family of quality management systems standards. These standards are designed to help companies ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.

ISO 9000 Requirements include:

  1. Approve documents before distribution
  2. Provide correct version of documents at points of use
  3. Use your records to prove that requirements have been met
  4. Develop a procedure to control your records

Document management and control is a cornerstone for ISO 9001. LuitBiz DMS provides the essential capabilities for controlling documents according ISO regulations and allows you to automate document management policies, control access to information, and secure a complete history of all document activity for auditing.

SEC Compliance

Required By: Brokers and dealers, and their associated persons, must comply with all applicable requirements, including those of the U.S. Securities and Exchange Commission ("SEC" or "Commission"), as well as the requirements of any self-regulatory organizations to which the brokers and dealers belong.

The Securities Exchange Act of 1934 ("Exchange Act" or "Act") governs the way in which the nation's securities markets and its brokers and dealers operate. SEC rules 17a-3 and 17a-4 specify the type of data records to be created and maintained by brokers and dealers and the length of time they need to be maintained. If firms fail to abide by these measures and enforce the adequate policies and procedures, they are placing themselves at risk to a number of non-compliance penalties, such as internal and/or regulatory disciplinary actions, damage of reputation, civil liability, penalties and more. LuitBiz DMS helps financial firms in SEC compliance through its easy to use and yet extremely robust and secured architecture.

Sarbanes-Oxley Act Compliance

Required By: Publicly traded companies, public accounting firms, auditors, brokers, securities analysts need to comply with the Sarbanes-Oxley (or SOX) Act. Under Section 404 of the Act, management is required to produce an "internal control report" as part of each annual Exchange Act report that affirms the responsibility of management for establishing and maintaining an adequate internal control structure and procedures for financial reporting.

According to SOX, companies must assess their document processes, structure them effectively and take steps to control risks. LuitBiz DMS helps companies access their document related risks, formulate risk management procedures and communicate them to users ensuring all security procedures related to security of financial documents are adhered to. Data Protection Impact Assessments (DPIA) helps companies assess and estimate risks and workflows ensure that the right approval process is followed for each document approval with password protected electronic approval.

Gramm-Leach-Bliley Act Compliance

Required By: The Gramm-Leach-Bliley Act requires financial institutions – companies that offer consumers financial products or services like loans, financial or investment advice, or insurance – to explain their information-sharing practices to their customers and to safeguard sensitive data.

This act states that customer data must be protected from any threats that could result in unauthorized use. Financial institutions covered by the Gramm-Leach-Bliley Act must tell their customers about their information-sharing practices and explain to customers their right to "opt out" if they don't want their information shared with certain third parties. This also includes all the personal information record documents that companies collect from customers. LuitBiz DMS can help secure these documents and ensure Gramm-Leach-Bliley Act compliance.