Moving to Software
There are many Benefits to move from paper-based system to a software one. Improve productivity and compliance, real time reporting, easier access, increased security, prep and pass audits, better communication & collaboration, endless storage, improved remote working
Implementing a new software solution presents many challenges. This process can be overwhelming, confusing, and time consuming. This is all the reason why companies never switch. This leads to efficiency and profitability issues as companies continue to operate their businesses in flawed ways. In addition, when a company takes the plunge and begins the software implementation process, poorly planned and unrealistic expectations can upset the project and result in cost spikes.
We can HELP!
We have a strong team of experienced consultants and project managers to ease this process.
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We will conduct a Software Impact Risk Assessment (SIRA)
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We will write and present findings and recommendations to get your operations ready to move to a software based system.
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We will Install and validate the software. Validation binder IQ/OQ (URS, DS, Test Scripts)
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Process mapping exercise, based on the SIRA finding s this will be a much easier process
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SOP Doc Creation
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PQ Document Creation
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PQ Execution Assistance
Processing mapping
Collecting Information
This entails collecting information based on the process flow of the Novatek system including for instance: sites, departments, users, user permission groups, drop lists, inventory process, specifications, product registrations, protocols, schedule generation, sampling process, sample incubation process, entering results and related result data, acquiring results, micro-organism IDs, investigation process, resampling or ad-hoc testing, review and approval process, batch release process, audit trail reviews, system configuration settings, required reports, trends, bar charts, pie chart, Weibull distribution, and system best practices.
Verifying SOPs
The process mapping activity is generally done in a meeting format where we go through the process flow with you/your team in the order listed above; asking you questions about each step, while verifying your SOPs as needed, to document each of the process flow steps above.
Worst Cases Study
We also define or learn what your naming conventions are such as the Spec ID and Protocol ID. Once we are familiar with your process in detail, we collect your worst-case data i.e. data for the most complicated processes. With this data and the defined process, we create PQ scenarios to validate the system against these worst cases and ensure the Novatek system meets your requirements while following your company’s SOPs/procedures.
Documenting
The process mapping activity comes with a document deliverable; our process mapping template is about 12 pages when it is empty (generally varies between 25-50 pages when complete depending on the company). Once completed with you, we send you a copy of it. This document may be helpful for your team to create an SOP/update an SOP surrounding the Novatek system and of course Novatek uses it to assist with additional activities such as the PQ (see below).
SOP writing
Novatek has a standard operating procedure for each of our software solutions. Customers can purchase these generic documents as a starting point and revise as needed to match their company’s internal policies and procedures.
Following a process mapping activity, Novatek will revise our generic SOPs – relating to the match your company’s internal policies and procedure.
Novatek’s software solutions are designed to be process based allowing for an out of the box solution that is easily configurable. Configurations include options such as user roles & permissions, site hierarchy for our multi-site clients, colour configuration, email notifications, report options, approval workflows, investigation numbering, testing priorities and more. Our configuration document is a template with all the options listed allowing your System Administrator(s) to independently keep track of the options and configurations chosen. Control this document once signed off for the best data integrity practices.
PQ documentation creation assistance
Novatek assists in the creation of your required PQ documents by starting with a thorough process mapping activity (note the process mapping service must be purchased prior to this activity). This ensures that the PQ scripts are a direct validation of your process within the software solution. In other words, the PQ validation scripts created verify that Novatek’s software meets your specific requirements as dictated by your company’s procedures. Scenarios are created to validate your worst-case processes within the system.
PQ execution assistance
Ensure a smooth and efficient PQ execution by having a Novatek validation expert at your side. Our experts can assist your validation executioner with immediate answers, avoiding human error and unnecessary deviations
