Effivity QMS and HSE Management software solution aids the pharmaceutical industry to respond to ever changing regulations, product innovations, global supply chain, consistency in products, supplier management, logistics and innovation while ensuring an efficient and effective QHSE management system as per ISO 9001, ISO 14001 & ISO 45001 standards and regulatory bodies like FDA.

Quality Management System ISO 9001 for pharmaceutical companies with Effivity

  • Overcome regulatory challenges with Effivity QMS and HSE Management software solution. Identify the stakeholders and their expectations with the Context of Organization module, conveniently determine the requirements and satisfy different set of regulations in each market by utilizing the Compliance Obligation module.
  • Avoid significant delays in production and improve production efficiency; Effivity QMS solution enhances the pharmaceutical industry’s process control. Effectively plan operations and identify processes in advance that have the potential to cause production hold ups and implement the appropriate mitigating response.
  • Manage supplier, supplies and incoming material / product quality as per established product quality plans. Evaluate and reevaluate suppliers to determine performance of various suppliers / sub-contractors and service providers.
  • Plan and record production, document deviations / non-conformities and close NCs to ensure they don’t reoccur.
  • Manage policies, objectives, plans, SOPs, procedures, processes, work instructions, guidelines, work instructions, method statements, forms, checklists etc. at a central place to ensure effective document control and availability of the most recent version of a document to the user.
  • Manage equipment, their maintenance and calibration through auto reminders and work flow to ensure manage your assets in the best operating conditions and reduce breakdown / production delays.

Environment Management System ISO 14001 for pharmaceutical companies with Effivity

  • Effectively manage environment considering life cycle perspective in the entire operations including Pharmaceutical Hazardous Waste with Effivity HSE Management solution. Characterize and effectively monitor hazardous waste and run-offs, implement adequate control measures and efficient disposal programs by utilizing the Waste management, HSE Planning & Operations modules.
  • Continuously improve processes, optimize production and realize costs savings, implement a robust environmental management system by capitalizing on Effivity HSE Management solution. Minimize waste by improving material consumption, have traceable and retrievable documentation on hazardous waste collection and disposal monitoring, improve workplace environment with designed environmental aspect controls, ensure conformance by systematically conducting self - inspections and internal audit.
  • Manage policies, objectives, environment aspect – impact assessment, operational control, emergency preparedness and environment performance with EMS module of Effivity.

Health and Safety Management System ISO 45001 for pharmaceutical companies with Effivity

  • Effivity HSE Management solution readily facilitates the pharmaceutical industry in risk assessments and hazard identification. The HSE Planning module enables the organization to identify hazardous chemicals, processes and operations. Identify vulnerable zones and critical physical & environmental receptors of these zones. Enhance controls and emergency response readiness by evaluating release scenarios and their consequences by using the HSE Operations module.
  • Effivity HSE Management solution enables the pharmaceutical industry’s operational readiness to respond to crises or sequence of emergencies. Use the functionalities of the HSE Operations module in preparing for disaster before it take place, and establish disaster response and support systems after natural or human- made have occurred.
  • Provide a safe working environment; Effivity HSE Management system allows the pharmaceutical industry to identify potential causes of emergencies in bulk, drug intermediates and Pharma formulations manufacturing units and recommend remedial measures in advance to avoid emergencies from taking place. Establish adequate precautionary measures to prevent accidents involving chemicals, processed or handled in bulk drugs, and drug intermediates.

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