Category Archives: Technology

About technology, gadgets in medical or other fields

Computer System Validation (CSV) – Emphasis In Implementation Of Good Business Practices

What is CSV:

Computer System Validation is the process of providing documented evidence stating that an electronic system or technology will perform as intended.

Heavily regulated industries:

The organizations falling into Finance, Life Sciences, Healthcare, Pharmaceuticals and Software are few sectors but not limited to that complies with regulations followed up with validations and audits.

HEALTHPARADIZE

What is FDA 21 CFR part 11:

It’s a set of laws binding and ensuring companies maintain, follow and implement the good business practices in their process throughout the operations. Part 11 allows a company to implement computer systems with a motive to increase the efficiency of individuals, mitigating errors, identifying risks and escalating the overall productivity of the organization while adhering to highest standards and Quality.

Code of Federal Regulation (CFR) has framed rules and regulations that refers to records and approval signatures that originally refers to paper documents and handwritten signatures. So, the part 11 allows the replacement of the paper records and handwritten signatures with the electronic record and electronic signature.

Here, the catch is about the rapid evolution in computer technology that has left the law forming agencies in total unstable mode, where the brainstorming for formation and restatement has become the daily activity and release of the updated notes to the public. The ever evolving technology has left many old way of regulations dead and would need reengineering the laws for electronic record for its credibility, security and authenticity.

It would really be nice enough for experienced person from various domains to add values to the regulatory body by sharing the ideas and projections. As in coming years, we would be seeing a lot of changes and revolutions.

21 CFR part 11 has following primary pillars as;

  1. SOPs:

There are plenty of SOPs for IT infrastructure that must be taken care. Since the move from paper based to computer systems reflects that the process, operations and other management and authentication would heavily be depended on the computer system, where the repeated tasks are being governed by the few lines of codes that helps in data capture, data validation, data authentication, system authentication etc. So, to comply with computer system validation, Data Security, Data Backup, CSV, other integrated devices that are used in capturing data or scans of human body parts must have a validated process. These all at the end helps in forming an electronic record authenticated by electronic signatures.

  1. Features of the System:

Computer Systems would ensure the data integrity for electronic data and electronic signature by having a strong set of mandated features like, audit trails, electronic signature validation, password validation and expiry rules, system login with verification or Single Sign On (SSO), stashing of the data post archival of the project to a secured server etc.

  1. CSV:

Computer System Validation is the process of providing documented evidence stating that an electronic system or technology will perform as intended. Risk-based approach for Computer System Validation has always been the best practice in industries to have greater results in terms of efficiency and cost monitoring.

Documented Evidence:

There are various source files and other relevant files and documents that must be associated with the evidence of documents while handling any computer system. Documents could be as follows but not limited to;

Risk Assessment, Scope, Detailed Validation Plan, Test Plan, Test Cases, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)/User Acceptance Testing (UAT), Traceability Matrix, Validation Summary Report, Roadmap of post go live plan, Support plan etc.

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Disruptions in Healthcare Sectors by High End Technology!

People from different walks of life are coming up with many questions but not limited to, when they see a healthcare expert or professional from technology side;

  1. Are disruptions good for the healthcare sectors?
  2. Are Healthcare Industries making better sense of available gadgets in market?
  3. Is automation really helping healthcare industries?
  4. Should industries adapt EMR and other integrated digital revolutions?
  5. Which gadget would fulfill my requirements?
  6. Which software/solution would be good to prefer for planned requirements?
  7. Will health system accelerate the adoption of the technology based solutions for their decision making?

EMR

Healthcare Education –hour of need!

The population has grown at such a greater pace that has left a big gap in ratio of doctors to patients. Population explosion has left system in a tremendous need of education, especially into healthcare system to deal with the overplusof diseases and other healthcare issues that’s making ground these days.

Training force to adapt technology/solutions!

The ever growing technology has made the system quite cumbrous that if you are not keeping up with the updates in market or in your profile, would feel left behind. Following the technology development that has to be a quality training by experts to follow the compliance and guidelines of HIPAA, USFDA, WHO and other state and country related compliance. There has to have a standardized training for the force before they start performing or dealing with healthcare system to eradicate the incidences that takes place accidentally.

How to choose the available solution in market?

There has to have a framed strategy to select the best possible solution from market, this need an ample of time to do ground work and analysis and comparison study to come up with best suggestion followed up your requirements and budget allocation.

  • Audit thoroughly the solution provider’s record keeping system
  • Audit the team that has been the backbone of the solution building team
  • Do Compare the features and ease of the solution with few more solution form market
  • Try to have guest login for a short period of time to know more into depth, your solution provider should definitely help you out with this
  • Compare the ratio of the customization that would require to be done at your cost
  • Do a dummy run to get acclimatized if needed, as solutions related to EMR and other diagnostic and analytical solutions has to be selected intelligently
  • Know the support system management of the solution provider (post implementation project management)
  • Do get the references of present partners and talk to them for experience for better evaluation.

Adapting Solutions in technology has become the part of your KPI and ROI

Technology has disrupted the market in many ways, well there is a point where every solution would not rock over other validation solution. So there has to have a plan to select the best validated available solution in market. As moving to a solution for your business and operations would be a challenge initially and this of course would become one of the KPI while reckoning ROI.

Approach towards adapting technology and better selection!

Hospitals, Clinics and other palliative centers are indeed trying to make good use of the available gadgets and technology solutions in market. Research and development process should continue at a greater pace to come up with more validated and apposite solutions to simplify and automate the readings, calculations, analysis and record keeping system and at the end data should sum up to a better representation with values and statistics to deal and handle for future challenges. Automation and digitization in every possible process of the operations bit by bit has helped gained momentum in overall operations in every industries. So, there is no second though about moving forward with digitization and automation if it is meeting your expectations and setting your ROI as projected.

Keywords:
Software, Solutions, Vendors, Audits, Technology, EMR, Automation, Applications, Integrations

 

Emerging Technologies in Business Intelligence & Artificial Intelligence

Technology has left no industry or business without being considered or undergone Gap Analysis by their own team or from consultancies. Companies running on manual process still, are the one who are spending a lot on their operations whereas at other ends, companies utilizing technology as a solution are continuously growing with their revenue and operations with least efforts.

Need of BI and AI in current process;

Gone are those days, when regular meeting, analytics, and derivations, strategy formulations, meetings where used to take place followed up with investment of time in face to face meetings and report writing. Now technology and algorithms are robust enough that may take decisions by recalling and scanning through the old data, capability for delivering reports in real time environment is being given utmost importance now.

BI systems have the capability to influence decisions that would have strategic impact on enterprise.

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Take away notes;

– BI can help organizations making sense out of their huge collected data

– AI can help giving insights to the strategy and business plans by learning from past

– AI can help making super decisions before the process ends, so in between decisions and insights of the process would really help organizations to save efforts, costs and time before committing for a big failure.

It is highly suggested for industries and organizations to undergo gap analysis, there is always a better way to optimize the operations for achieving revenues and quality with technology.

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Growing technology with unaddressed questions and scenarios

Technology is growing and changing at such a fast pace, that today’s development and concepts get old by tomorrow!. Code’s or machine’s ability to learn and response without being programmed has become utmost popular and is leading most of the daily process, where least human involvement is required now.

Focusing on the trend of data being generated from ample of processes on day to day basis in organization has lead Machine learning to emphasize more on the development part where programs can be developed to deal with new strains of data from the various processes.

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The pace at which the data is being generated from a small process or a bigger process is in equal demand for auto capture of the data from one end and should be analyzed by the system at front end with all possible scales and speculations for quicker decisions by the management.  Following this now the trend of the development of algorithms has made shift from writing “supervised algorithms” to unsupervised algorithm, where the supervised part of the algorithm gives better insights into the new data from past data and unsupervised part concludes from the old datasets.

Process Software should be backed by the statistical analysis and predictive analytics to make artificial intelligence and to automate the decisions making ability in process(es).

Though even if organizations and regulatory bodies make standard guidelines for electronic technologies where the ample of codes are being run to capture, store, clean, analyze, and present the result in fractions to the user, will again keep on changing and evolving with growing technology. This process would leave behind the QUESTIONS and SCENARIOS unaddressed!. Manual and Automated testing of the application would not be sufficient to make application stand with data set variation.

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Artificial Intelligence – challenging human minds with rational agents!

It has become challenging for humans to beat computer systems and logics formulated behind them. Developed by humans for the excellence of processes in day to day life and for the care of population.

There are four ways of approaching Artificial Intelligence:

  1. Thinking humanly – cognitive science
  2. Thinking rationally – logic
  3. Acting humanly – turing tesing
  4. Acting rationally – rational agent

Thinking or acting deals with thinking processes or behavior, while humanly or rationally means humanly or to do the right things.

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The AI approach has been taken to such a level where robots and software are communicating with human in their language. In fact the AI’s approach is to act rationally and to build rational agents, and these agents are nothing but the robots and software.

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Gestation of Artificial Intelligence (AI) was from 1943-1955, where the AI developed in a cogitative process. First work on AI was started by Warren McCulloch and Walter Pitts in 1943, where the duo developed and worked on artificial neuron model where the neurons where either on or off to function.

“How AI has become an Industry” and entire processes has been given a cobwebbed connection to increase the production and output by many folds. None of the major processes in industries are free from software applications and machines that are guided by codes.

Challenges to be handled in future:

Though this ever growing technology is helping each and every one of us and at the same time it is keeping humans away from the nature and that’s where the natural processes are evolving and leading to a world of so many unexpected disorders, health issues.

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Quality maintenance in Software and Web industries with RCA & CAPA

Root Cause

A root cause is a factor that causes a non-conformance or deviation from a defined path and should be permanently eliminated through process improvement and analysis. Root Cause Analysis (RCA) is a tool to help identify what, how and why an event has occurred so that proper steps can be taken to prevent future occurrence.

RC can also be to target opportunities for system improvement. It can be attested that root causes are specific underlying causes that can be reasonably located and are mostly management’s control to amend and it helps generate effective recommendations to prevent recurrences.

healthparadize

Courtesy: http://www.mastercontrol.com/

RC Analysis process involves data collection, causal factor charting, root cause identification, recommendation generation etc.

Resolving a quality problem could be done with correction, correction action or preventive action! These actions under regulations also require proper identification, documentation, evaluation.

Correction: is a type of action, correction is a change that makes something right, true, accurate or better. It is also defined as an action taken to eliminate a detected nonconformity.

Correction Action: is action taken to eliminate the causes of a detected nonconformity or quality problem. The deemed action is intended to eliminate the recurrence of a quality problem that has occurred. Post applying correction actions to confirm the issues is not being faced again. This is called verification of effectiveness, which manifests that the actions have addressed the root causes of the problem to reduce or eliminate their effect, depending on the goal of the CAPA.

Preventive Action: is action taken to avoid occurrence of a potential issue.

What action is being taken to amend the issue is of utmost importance in ensuring safe and effective products.

RC & CAPA is a team effort that should be address properly in most of the cases. Leaving the same unaddressed may worsen the issue(s) and later may require lots of description and time digging up the bugs and relevant parts that has been impacted.

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Next Generation Sequencing (NGS)- breaking the human genome code

So far now, it has become possible to sequence anyone’s genome cheaper and quickly with the help of latest technologies. Researchers have started gaining much into discovering the meaning of individual genomes. Though still the sequencing has not come down to an affordable price but has been sponsored mostly by the stake holders of the research projects to get into the main stream of the genomics worlds. And it has been highlighted that the individual genome sequencing would help track the rare deformities and anomalies in the gene line of human and can be engineered to treat or suppress the genes responsible for the cause.

newsystemtoi

Concerns over the repository of the genome sequences:

  • If the genome is sequenced, who should access this?
  • How securely the sequences can be stored away from snooping?
  • How the national database should be made?
  • Would it be easy to handle fastest growing data of sequences?
  • Would this be easy to make available centrally for right access?

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