Life Sciences Solutions - SOP


Being in Products Manufacturing , R&D center, commercial business with multi-national pharmaceutical companies, the life sciences organizations has to deal with a lot of critical Standard Operating Procedures (SOPs) and SOPs is a requirements of GMP. Life sciences industries require a scalable and agile solution to streamline SOP lifecycle management adhering to strict compliance and regulatory frameworks.

The Challenge
Life Sciences industry is subject to the regulations mandated by the government and other professional bodies including the Food and Drug Administration (FDA). The regulations include strict requirements for to write, manage and follow company’s Standard Operating Procedures (SOP). Managing and enforcing effective SOPs are challenging and often lead to the common causes of nonconformities of regulatory compliance.
Some of the Key Challenges are:

  • Manual Standard Operating Procedures (SOP) with physical storage and manual review and publishing process leads to tracking difficulties, increasing turnaround time (TAT), resulting in security breaches and compliance issues
  • Quality Assurance team face a lot of challenges tracking the right version of SOP at right time and wearisome process of manual approval using pen-paper-desk or email
  • Manual SOP and Format issuance control with hard-copy registers and distribution of SOPs to internal and external entities becoming a real-time challenge for the authorities to control the unauthorized usage.

The Solution
Life Sciences enterprises can now drive up operational excellence with streamlined SOP management using FineDocs SOP Solution ensuring compliance.
The solution platform provides:

  • SOP lifecycle management with creation, review, approval, publishing, revision and finally phase-out in a well-defined workflow with complete audit trail along with strict change control processes to assure compliance with GxP quality guidelines and regulations
  • Training of SOP is also a vital part of SOP management and FineDocs automated Share-Link integration touchpoint with legacy E-Learning Management System (ELMS) and other core systems.
  • SOP and Format issuance for training and distribution with view and print access control
  • FDA 21 CFR Part 11 compliance for electronic records and signatures

The Benefit
FineDocs SOP management ensures greater control on SOP enabling Life Sciences industry open up new ways to streamline work and gain new insights of digital excellence.
Some of the Key Benefits are:

  • Streamlined Standard Operating Procedures (SOP) lifecyle management, adding speed and efficiency in training and knowledge sharing process
  • Increased transparency in collaborative working as managing SOP documentation across divisions and units of R&D, quality and manufacturing becomes faster with improved operational performance eliminating redundant tasks
  • Improved access to SOP within seconds anytime, anywhere with a reduced downtime to approx. 80% with a greater control to manage, share and reuse information from a single source of truth
  • Reduced physical storage and maintenance cost burden to 70-80% as life sciences can now manitain less physical pieces