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
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
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.
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
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
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