Highly Secure Document Management to Maintain Electronic Records with eSignatures
Blog | January 13th, 2023

Highly Secure Document Management to Maintain Electronic Records with eSignatures

In regulated industries such as life sciences and medical devices, the value of a world-class document management solution cannot be emphasized enough. It offers uncountable benefits, including the following:

  • Serves as a single source of information and ‘real-time’ data
  • Makes compliance easier when documents can be accessed anytime, anywhere
  • End-to-end visibility for multiple stakeholders
  • Seamless data governance and user authentication
  • Provides a central repository to create, modify, review, approve, store, organize, access, and share documents globally and compliantly
  • Track each document from origin to obsolescence – with analytics, graphical dashboards, integrated collaboration, and workflow tools

The Regulatory Requirement: 21 CFR Part 11

21 CFR Part 11 has clear requirements for maintaining electronic records and documents with e-signatures. The primary goal of the regulation is to ensure the Regulatory Affairs (RA) team has the necessary tools to ensure the security of its documents.

In today’s world of imminent cybersecurity threats and attacks, it has become imperative to have defense mechanisms in place, especially for critical documents.

According to 21 CFR Part 11, every electronic record with a signature must include the following:

  • name of signer
  • date and time of signature
  • unique user ID
  • digitally adopted signature
  • signing reason

With ComplianceQuest’s Document Management Solution, documents at scale can be managed in a versioned, controlled, and secure way. From an e-signature (eSig) perspective, we have the following in place:

eSig Verification

  • with password
  • with SSO Credentials
  • Multifactor Authorization (MFA)
    • using a Temporary One Time Password (TOTP)
    • using an Authenticator App
  • Hide Comment During eSig
    • configurable by customer

ComplianceQuest Document Management: A Preferred Solution for Medical Device, Life Sciences, and Manufacturing Companies

While choosing a document management solution, decision-makers look for the following capabilities:

Is Collaboration Easy?
With CQ EQMS, the process of reviewing, modifying and sending documents for approval/signatures is intuitive. Thanks to CQ’s integration with Microsoft, Google, and BOX it becomes simpler for quality and compliance teams to share and collaborate on documents with rest of the organization. You can tag other users, suppliers, contractors and auditors to access a document on the move all from within the CQ EQMS system, Not only, but advanced features such as document compare make collaboration between teams even easier, making sure Quality and Safety processes are moving at lightning speed.

Does it Make the Audit Process More Efficient?
It is critical to transform your document management workflow to satisfy quality and safety regulatory compliance, from ISO 9001, OSHA to GxP standards. During audits (or inspections), it must be quick to pull up documents without wasting time.

Are Documents Easily Accessible?
Documents across Quality and Compliance processes such as surveillance audits, CAPA escalations, non-conformance, change control, safety observations, permit to work and customer complaints must be easily accessible. With CQ Document Management Solution, a document is just a few clicks away – yet it comes with utmost security.

Does is it Simplify Training and Related Documentation?
For Continuous Improvement (CI) of quality performance, training and SOP documentation are critical. When there are gaps in the quality process or when change is needed following a root cause analysis process – training is scheduled for relevant team members. For this training to be seamless, documentation is crucial.

Overall, CQ Document Management Solution is designed to improve productivity and efficiency. With a workflow-driven process aided by secure digital capabilities, you can simplify the process of creating and updating documents, always ensuring the right templates are used. With CQ, you can:

  • Streamline the entire document review/approval process easily, on a consistent and timely basis.
  • Increase operational efficiency by improving access to the right version of your information, faster and more cost-effectively, regardless of platform
  • Whether it’s SOPs, policies, plans, work instructions, or manufacturing & production designs, the most current information will always be available and accessible, reducing both time and risk

For more information, request a demo: https://www.compliancequest.com/lp/eqms/

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