Paperless GxP Regulated Business Processes

MSB Docs enables an end-to-end smart document solution throughout the GxP spectrum. This, in turn, helps in:

  • Eliminating Paperwork
  • Accelerating Approval Times
  • Reducing Errors
  • Minimizing Operational Costs
  • Improving Collaboration

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What is GxP?

GxP is a general abbreviation for the “good practice” quality guidelines and regulations that were established in the U.S. by the Food and Drug Administration (FDA). These guidelines and regulations ensure that bio/pharmaceutical products under consideration are safe to use and meet their intentional use. Since the quality is not compromised in the industries that directly impact human health, GxP has special guidelines to check whether the products adhere to the quality processes during manufacturing, control, storage, and distribution or not.

Challenges Organizations Face with GxP Regulations

In order to ensure that the quality of the goods or services is consistently high, organizations need to focus on the following areas:

Traceability

Traceability

Having a way to reconstruct the entire history of a product provides you traceability within the system

Accountability

Accountability

The ability to demonstrate the contribution of each person in the product enhances accountability.

Integrity

Integrity

Ensuring that there’s a minimum deviation in the promised quality standards maintains integrity.

Accuracy

Accuracy

Keeping the clinical trials and the experimentation carried out in check ensures accuracy.

Availability

Availability

Conducting routine audits and thorough documentation maintains availability of current data.

Consequences

Carrying out GxP regulated business processes manually has more chances to deviate organizations from these primary areas. Still, manual processes and paper are widely used in many life science organizations, delaying product launches, and increasing development costs. In other words, leave them behind the competition.

Consequences

How to Do it Right?

Go Paperless & automate processes to connect the entire agreement process. This increases the process efficiency and productivity, and let you market faster and keep your business moving forward.

Partner with industry expert that let you carry out document transactions which meets FDA Regulations.

Choose a solution that has 21 CFR Part 11 Module in place.

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Download Paperless GxP Compliance Guide

Switch to paperless GxP compliance and realise additional savings, better turnaround time & faster approvals without the “paper”.

  • What is GxP and why is compliance necessary?
  • How does paperless compliance fare against the usual methods?
  • How does paperless GxP compliance impact an organization’s bottomline?

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    How MSB Docs Helps?

    MSB Docs implements a secure and easy to use smart document solution that adheres to GxP regulations. Going paperless is easier than ever with us! Moreover, MSB Docs platform is implemented on compliance with 21 CFR Part 11 requirements on electronic records and signatures. The following industry-designed capabilities that we offer make us stand out from the crowd.

    Account Configuration

    Each MSB Docs account is configured based on the roles, access rights, and permissions within the system to ensure authorized access to the system.

    Signature-level Credentialing

    A routing sequence is maintained based on signature level credentialing for operational system checks to enforce permitted sequencing of steps & events.

    Signature Components

    Time and date stamp along with a defined Audit Trail is made available for each document that is being transacted especially for FDA review and copying.

    Signature Controls

    There are different layers of security and 2-factor authentication for accessing, revising, and changing the data in the document.

    Signature Manifestation

    A printed name of the signer, date, and time of signing and the meaning (such as review, approval, or responsibility) is associated with each signature.

    Team Room

    A custom solution for superfluous collaboration on a document within a team while maintaining regulatory sanctity & the security of the transaction.

    Our Happy Clients

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    Why MSB Docs?

    MSB Docs lets you carry out the processes while ensuring accuracy, reliability, consistency intended performance, and the ability to discern invalid or altered records.

    SOPs
    SOPs
    • Industry Standard SDLC SOPs: Engineering, Verification, Validation, Release
    • Master Validation: IQ/OQ/PQ​
    • Role based system access​
    • Independent QMS
    MSB-Features
    MSB Features
    • Strong access control​
    • System generated audit trail​
    • Binding signature​
    • Signature validation​
    • Independent eSignature verification
    Audit
    Audit
    • Demonstrate traceability of Customer requirements with MSB feature​
    • Host Customer audit​
    • Process and Product quality assurance​

    Need more Information?

    Request A Demo





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