If you're in a regulated industry, complying with regulations isn't optional.
If you're still managing your compliance documents by shuffling paper, you're doing it wrong.
You can digitize your documents and then manage them electronically with document management. There are additional benefits, such as the ability to automate workflows, but for today we're going to focus on the fourth of the 4Cs of document management: compliance.
The four Cs are:
As a manufacturer, there are regulations around ISO, HR and employee training needs, privacy, finance, and more.
Relative to document management and how DM can support your company, your needs boil to having to survive an audit.
Document management makes passing a compliance audience much easier than having to move from desk to desk, filing cabinet to filing cabinet, and shared drive to shared drive in an attempt to find the documentation needed.
A key part of any compliance audit (HIPAA requirements around patient information, SOP and training programs, SOX requirements, etc.) is an audit trail.
A document management system generates an audit trail for each document in the repository – who accessed a document? When was it accessed? Combined with other software, like print rules, you can even track if a document was printed and by whom.
Access to and authentication of documents is managed by security controls that restrict access to documents (as needed) by password, user role, individual, etc. Version control maintains a record of changes to a document and the ability to share the most current, relevant version with appropriate employees.
For instance, you have an OSHA requirement to show that training levels are maintained on various pieces of equipment in your manufacturing processes. A DM system can quickly show all training materials, that they are up-to-date, that relevant employees have seen and signed off on any required training, etc.
The inability to provide documentation to meet an audit's requirements can result in fines – or additional staff time to meet requirements.
DM can help with security compliance audits and even risk management by serving as the repository of relevant documentation. Placing all policies and procedures in a single repository allows them to be quickly accessed and updated as needed. Having one place to store user access logs, changes to the network, incident reports and responses can be combined with a company's official policies to show that those policies and procedures were followed.
Compliance and Audits: Simplified
Back to those paper documents and the time it takes to pull and prepare the ones requested by an auditor.
Here's how you could do that with a DM system:
- Search for relevant documents
- Save them to a thumb drive
- Hand the thumb drive to the auditor
You can also allow auditors into your system to search themselves.
Of course, a DM system isn't the only thing you need to be compliant – compliance is a broad category.
However, does this sound like a better way to meet compliance needs than whatever you're doing now?