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Audits & Records Management

Be Compliant Before an Audit Happens

Today audits occur across a multitude of organizational activities; financial, employee health and safety, facility operations, performance management, security, quality operations, manufacturing, records management, and research and development.  The ability to immediately produce documentation relevant to specific audit requests, especially in regulated industries and across all these named areas and others, has assumed tremendous organizational importance.

Our particular expertise lies with the pharmaceutical, medical device, insurance, and financial industries. Governmental and industry rules and international standards and directives are gaining in number and complexity. Noncompliance leads to audit observations and findings which can have detrimental legal and financial implications for organizations.

An audit will delve deeply into an organization’s systems and processes to ensure they are compliant with both internally documented procedures as well as external requirements. A records management compliance program that meets and exceeds audit requirements is one that is complete and comprehensive, routinely followed, and continually monitored.

Getting audit-ready can be time-consuming and resource-intensive. This preparation pays off with the assurance that your records management systems are well designed, compliant, and legally defensible. Anticipating what questions auditors may ask is an important step in avoiding difficult questions, minimizing negative audit observations and expensive corrective actions.

Become Audit Ready

System Design Partners can assist you to achieve audit readiness by:

  • Reducing audit preparation time and cost
  • Filling critical resource voids
  • Enabling strategic resource deployment
  • Meeting tight reporting deadlines
  • Improving auditor relationships

We achieve these benefit by:

  • Knowing which regulators will audit you against what specific requirements. Everyone in your company is responsible for managing records. Our Records Management Training Programs are invaluable toward ensuring everyone knows how to manage records to mitigate audit and litigation risk to the company. We know what auditors look for and can assess and assist your efforts to prepare.
  • Ensuring your records management policies are clear, concise, effective, and followed. Policies and procedures related to records retention schedules, offsite storage,  records retention, security, access, and disposal should be complete and easy to understand. Working with senior management and other company stakeholders, we develop these policies, train employees on these policies, and ensure that compliance with these policies is documented. A few red flags will put an organization in a bad light more quickly with auditors than having policies that are not followed or enforced.
  • Self-Assessments. The best way to prepare for an audit of your Records and Information Management program is to conduct your own, either with an internal team or, ideally, using an unbiased, outside resource. Test every policy, process and technology, from how records are created and stored to how they are protected and destroyed; in short, a record’s entire life cycle. Document the results, any gaps identified, the actions required to address those gaps, and the timing and completion of those actions. Self-audits are most effective when done regularly and with the involvement of all employees with records responsibility.

If you are facing an Audit or simply wish to improve your compliance processes, contact System Design Partners (1-888-992-1670) for a free consultation on how we can help you.


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