On this blog, we frequently write about how Laserfiche and CPS help solve problems for agencies. For this post, we’ll be addressing some document and compliance issues for manufacturers.
Manufacturers are beholden to many regulatory requirements. One of which, Current Good Manufacturing Practices (cGMP) include an element of document control. Recently I read that the FDA sent almost 500 warning letters about violations of these practices.
When the manufacturer receives a warning letter, they’ll need to provide audit-ready documentation to prove that they’ve taken corrective action (CAPA) to avoid further negative impact. While it is certainly possible to use paper-based methods, it’s much more difficult than using Laserfiche to automate quality management. The document control that Laserfiche offers can eliminate lost documentation, alert stakeholders to process issues and streamline CAPAs.
As seen through the lens of Laserfiche, what is a document control system?
In manufacturing a document control system is the most critical tool for compliance. Organizations at every stage of the lifecycle can benefit, from startups to organizations approaching approval for the market.
A document control system supports the management of files in compliance with regulations and quality management processes for documentation such as FDA, ISO, EudraLex, etc. Document control software systems support process automation, the management of quality documents such as CAPA or non-conformance reporting, and, importantly, audit trails.
Why should manufacturers have a document control system?
As a manufacturer in a highly regulated industry, compliance is of great concern to you.
While reduced regulatory risk is a major benefit of Laserfiche, it’s far from the only positive one. The right solution can improve information security, increase transparency, reduce business continuity risks, augment collaboration and records management In addition, it can act as a repository middleware for documents to provide context for the line of business systems such as ERP and CRM. Here are a few examples of benefits that can be derived from document control:
Access control- Ensuring that only the right people have proper access at the right time is key to compliant identity management. Without appropriate access governance, paper-based systems or ineffective paperless methods can introduce the risks of information leakage. In highly regulated industries, accidental data exposure could result in non-compliance, loss of competitive advantage, brand reputation damage, or other threats.
Transparency, when necessary- Sensitive information should be protected from exposure to the wrong parties. They should also support simplified access when needed by allowing authorized parties to quickly search, find, and retrieve archived and active records. Additionally, comprehensive audit trails to monitor document views and edits are necessary to prove compliance.
Auditing compliance- Poor document control systems are a frequent cause of issues with regulatory agencies. Laserfiche offers a software-based method of managing document quality that can reduce the risks of incomplete documentation, incorrect forms with signatures, or spotty audit trails. Some of the functions of auditing that regulatory agencies look for are easily automated with Laserfiche such as complete revision history, identities of editing parties, recall of outdated SOPs, and safeguards against unauthorized revisions or deletions or altering of records.
If your organization’s software or paper-based approach to document control doesn’t meet these standards, you could face regulatory risks and pay the potential cost of non-compliance. Why not check out Laserfiche by contacting CPS?