Records Management Program Development

January 5, 2018 by sdpblogger

Records Retention Schedules

The foundation of any legally compliant records management program is a company Records Retention Schedule for each department. We are experts at simplifying retention schedules such that all company personnel are able to easily adopt that schedule and follow the policies and procedures tied to retaining and destroying records independent of media.

Our approach to developing records retention schedules includes our experienced knowledge of business operations and regulatory requirements. As we have greater than twenty-five years of experience organizing and conducting records purges, records inventories, designing, developing and administering electronic records management systems as well as conducting all associated training for clients, we are expert in developing unique and successful records and document management programs. Our services include creating legally-defensible enterprise-wide Retention Schedules, performing accurate custom legal research for specific industries and jurisdictions, and updating existing records retention schedule to reflect any changes in record keeping laws and regulations to ensure continuing compliance.

Document Management Database Development

The Challenge

As we operate in continually evolving regulatory environments, many organizations across various industries face not only multiple compliance and regulatory demands, but also the challenge of managing costs to operate efficiently and competitively. Inefficient, expensive paper-based policies and procedures cut into profits and unnecessarily complicate workflow, often challenging timely audit and legal discovery response. At the same time, the rising cost of compliance is making business more complicated. We can help.

The Solution

There are many strategic benefits of implementing a digital document management solution:

Increase information security
Streamline compliance with retention requirements
Expedite audit and legal discovery by quickly producing the relevant records on demand
Reduce the costs of document storage and retrieval
Simplify compliance with business directives
Transform compliance from a cost center into a competitive advantage

The Benefits

Document and content management systems provide organizations with the capability to increase business value, streamline workflow and simplify regulatory compliance. A digital document management system cannot guarantee compliance, but it can ease the burden of complying with increasingly stringent retention and regulatory requirements. Recent examples, for the Medical Device industry specifically, are the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) published in the Official Journal of the European Union 5th May 2017 with full application expected of medical device manufacturers who wish to continue marketing devices in the EU by 2020. The changes are complex and there is a lot to do in a relatively short amount of time. Examples of new regulatory requirements brought by the MDR/IVDR include but are not limited to increased clinical evidence, additional expert panel review of high-risk innovative devices, additional labeling requirements and reinforced lifecycle management controls, leading to higher resources needed to bring and keep products on the market. They also impact other key stakeholders like importers, distributors, Notified Bodies and National Health Authorities, as they span across the overall functioning of impacted organizations.

Other industries face similar specific challenges of their own. With the right technology, companies can gain efficiency, improve profitability and increase productivity, all while effectively ensuring compliance. System Design Partners can help you develop and implement important document management solutions. Our areas of expertise include analysis and inclusion of:

- Audit Trails that list who accessed documents, where, when and what they did with them
- Authorization Controls that define and restrict access to documents, files and projects to prevent inappropriate access, fraud, theft, or unlawful disclosure
- Functionality Controls limiting who can do what with a document
- Encryption to ensure the security and privacy of electronically transmitted data
- Administrative Safeguards that document compliance procedures to ensure regulatory specifications are met
- Technical Safeguards to ensure the privacy of information that is transmitted electronically
- Documented Processes based on a workflow system
- Archiving of searchable scanned images and electronic files (e-mails) to ensure legal admissibility and preservation

PROFESSIONAL SCANNING & E-MEDIA SERVICES

Leverage your organizational information and institutional memory by converting your paper and electronic media records into fully searchable and easily accessible electronic document repository. System Design Partners offers our customers specialized solutions that combine the right software systems, training, and quality control to get your information available in electronic format quickly and easily. We provide our clients with:

A Collaborative Approach. We believe it is of the utmost importance to completely understand each of our client’s individual requirements and provide each one with a customized solution that ensures records are quickly retrieved, particularly for audit and discovery requests
Scalable Solutions. We have converted many different volumes of paper and other media based records from both our smaller clients to our large enterprise-wide clients
Validated Software and Hardware. We are experts in validation. We can assist with this effort or, if validated solutions are already in place, leverage those and ensure such important options such as full-text document content searching, customized architecture (database folders and fields) structures, audit trails and data analysis functionality are in place
Organizational Efficiency. Reduce your company’s physical footprint, save square footage costs and retrieval time, and protect vital information by converting paper records and old file rooms to electronic databases and purging physical paper records that have met or passed their mandated retention requirements

RECORDS MANAGEMENT TRAINING PROGRAMS

Throughout our years in business, we have developed records management training materials and conducted training seminars both for large and small clients. We know the importance and necessity of training all levels of personnel within and organization to ensure that the time and energy expended on the development of records management programs, policies and procedures achieve compliance. Our training materials and programs are customized to meet each client’s individual needs, thus targeting and effectively mitigating risk.