Why do you require SOP management software?

Pharmaceutical, Healthcare, Life Science and Biotech industry operating in this intense competitive and complex regulatory environment needs to define their quality objectives articulately and ensure that these quality benchmarks have disseminated within the organization effectively. The organization also needs to define processes to attain those quality objectives called “Standard Operating Procedures” (SOP). Hence you need a SOP management software.

Standard Operating Procedures (SOP) in general is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization. The development and use of SOPs are an integral part of a successful quality system.

A typical Pharmaceutical Industry has an average of 1200- 1300 SOPs. One of the main objective of effective SOP management is to lighten the dark ambiguous world of roles and responsibility. SOP defines these following points:

• What is the objective of SOP (Purpose?)
• What are applicability and use of SOP (Scope)?
• Who will perform tasks (Responsibility?)
• Who will ensure implementation of procedure (Accountability?)
• How tasks will be performed (Procedure)

Companies generally manage these SOP’s manually and forced to face below obstacles & challenges like:

• Take long time to prepare SOP’s for various processes and departments
• Time / money/ effort consuming
• Unable to meet deadlines for review
• Delays in approvals
• Delay in training to staff about amendments
• Ineffective and insecure way of keeping and controlling SOP’s

QEdge-SOP management software provide you centralize and secure platform of keeping all your SOP’s and related documents like CAPA, training, change control, customer complaint, nonconformance etc. QEdge-SOP management software offers a system to manage and track SOPs and SOP life cycle that includes creation, review, approval and release along with distribution and achieving.

QEdge- SOP management software is a web based and easy to deploy solution is Title 21 CFR Part 11 compliant so that FDA-regulated industries, such as biotech companies, biologics developers, CROs, CMOs, drug makers and medical device manufacturers get an electronic data management system that is controlled and validated, including transparent audit trails, reporting and export capabilities.

Reasons to upgrade

• Comply with quality and regulatory parameters
• Reduce time/cost/efforts
• Improve Operational coordination
• Increased document security and control
• Lower document management and archiving costs
• Better knowledge management and search
• Minimize the cycle time for review and approvals

Are you ready to upgrade?