GSK

GSK Achieves 69% Improvement in Regulatory Compliance with MSB Docs

MSB Docs has completely revolutionized the document management processes at GSK. The ability to sign documents from anywhere, anytime, from any device has expedited our approvals process, thus making our transactions seamless and efficient. The eSignature solution comes with a secure audit trail, which helps us ensure compliance with FDA and HIPAA standards. The automatic date-time stamp embedded within the signatures are an extra security cushion. Truly, MSB Docs has exceeded our expectations in all ways. Their one-stop next-gen digital solution maintains the same level of care and duty as the traditional methods.

Compliance Officer, GSK

Key takeaways

  • GSK identified that the time spent on the traditional signing routine was delaying the business processes.
  • GSK needed a scalable solution to cut costs, improve efficiency and accelerate the turnaround time.
  • GSK integrated MSB Docs with their internal document management system that accelerated the secure document transaction while verifying user identity.
  • MSB Docs proved to be a vital solution in providing esigning capabilities and detailed audit trail that supports compliance set by the FDA and HIPAA.
Table Of Contents

The Company

GSK is a global pharmaceutical and biotechnology company, engaged in the research, development and manufacture of pharmaceutical medicines, vaccines and consumer healthcare products. The company offers drugs for the treatment of various diseases such as HIV, cancer, respiratory, anti-viral and many others. With innovation at its core, GSK has been continually expanding its portfolio of offerings with an aim to prevent and treat more and more diseases.

Business Challenge

As a leading pharmaceutical firm, GSK conducts voluminous documentation for processes such as clinical trials, R&D, new drug/ vaccine discovery, quality assurance and many others. Countless documents are required to be created and approved at each stage, which if done in an untimely manner, can delay the entry of medicines and treatments into the market.

However, GSK traditionally relied on manual, paper-based processes, where documents were physically printed out and then routed through different stakeholders for their approvals. Often, these signatories were located in different parts of the world, which made collection of signatures almost similar to a nightmare. Moreover, once all the signatures were gathered, the signed and dated documents were then recorded and stored offline as proof of discovery and patent defense for the drug.

These complex processes became a burden for GSK, which began to face the following key challenges –

  • High Turnaround Time – The company spent excessive time on the traditional signing processes, which involved repetition of the print-sign-scan-store routine, faxing documents, chasing signatories, etc. All this was delaying the filing of patents and other intellectual property rights. Also, the product development process was being delayed, which in turn deferred the delivery of medicines into the market.
  • Compliance Issues – The pharmaceutical industry is one of the highly regulated industries in the world, where adherence to industry laws and guidelines is strict and mandatory. The heaps of paper documents which had to be signed and processed manually invited various delays, due to which GSK was having troubles in staying compliant with the regulations.
  • Storage and security issues – Since the documents were manually archived, information retrieval proved to be difficult and time-consuming. Moreover, as a pharma company, there was an acute need to ensure security of sensitive and confidential documents, as they got exchanged or stored. This was also important from the compliance and regulatory point of view. Verification of user identity in document transactions was also a key concern for the pharma giant.
  • Plummeting Staff Productivity – The staff at GSK was totally consumed and exhausted by fulfilling the day-to-day documentation requirements, which had taken a toll on their overall productivity.
  • Staggering Costs – The company incurred enormous expenditure on printing, scanning, faxing, shipping and maintaining documents. The cost of resources deployed to conduct these paper-based tasks was also significant.

GSK was proactively looking out for a new-age, scalable solution which could help the company overcome the existing challenges and thereby make its product development lifecycle agile and efficient.

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What Did MSB Docs Do?

GSK chose MSB Docs to turn things around for them by eliminating the complex paper-based processes. A seamless integration of GSK’s internal document management system was done with MSB’s electronic Signatures. The highlights of the solution implementation are given below –

  • MSB Docs automated all the company’s workflows, which converted all its physical documents into electronic ones.
  • Users/ pharmacists at GSK can now quickly and directly upload documents onto their document management system using MSB’s platform. MSB Docs then automatically sends a signature request email to the signatory, the link in which can be clicked immediately from any device to apply signatures.
  • Once the user applies signatures, MSB then automatically notifies the next signatory, based upon the workflow attached. The document then automatically gets updated and stored in their central repository.
  • An automatic date-time stamp is embedded within the eSignatures, which provides the accurate timing of when the document was signed.
  • Robust audit trails help maintain a complete track of all documents and various actions performed on them at different stages. Audit trails also support compliance set by the FDA and HIPAA.
  • The simplified yet enhanced device capabilities ensure a simple and intuitive user experience on all devices.

The Key Outcomes

Thanks to MSB Docs, GSK has successfully replaced its traditional, paper-based processes with modern, digital ones. The integration has been a boon for the pharma company, as it reaped the following key outcomes –

  • Reduced document turnaround time – Approval times at GSK are faster now, as all internal and external signatories can now sign documents securely from anywhere, at any time, using any device.
  • Improved regulatory compliance – GSK achieved 69% improvement in compliance with regulatory requirements. This was a huge win for the pharmaceutical company.

    • MSB’s eSignature solution helps pharmaceutical companies in effectively meeting their compliance requirements with regulations such as FDA 21 CFR Part 11 and HIPAA.

  • Significant reduction in costs – By eliminating the costs incurred on paper-based processes, the company has been able to make significant savings.
  • Improved staff productivity – Simplification of documentation has improved the staff performance dramatically. The pharmaceutical scientists are now able to spend more quality time in conducting their experiments and less time in chasing paper.
  • Improved safety and security of records – MSB Docs eliminates all risks of document misplacement, tampering or any unauthorized access, since user identity is now duly verified. Moreover, all documents are now securely transferred and stored in the central repository, ensuring complete data safety.
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