Designed and developed by Gerizim Technologies, “LogicMind” is a cutting-edge quality management system. This QMS system is dedicated to help the quality managers in Pharmaceutical, Healthcare and Biotech industries. It facilitates the users to follow all the industry trends and regulations strictly while production of healthcare products. To streamline the quality management process, it brings various significant documents, including SOP, Training, CAPA, Risk Assessment, Change Control and etc. It also makes market complaints and investigation available on a single platform. Every company has a certain set of rules, regulations and policies and LogicMind is a dynamic & personalized system that is compatible in various environments. Once it is configured in a company, it works according to the specific policies and quality processes. The overall quality management process can be automated with this software. Moreover, you can be used to streamline various other operations in a company. Below are our solutions for Health care industries,
LogicMind softwares will ensure data integrity
Standard Operating Procedures or SOP are a set of quality objectives in pharmaceutical, life science, healthcare and biotech fields which are required in the prevailing compound and cut-throat environment. These organizations need to characterize the process of acquiring these SOP objectives. SOP management Software is great as it assists in maintaining the process on clear pathway and provides first rate quality with augmented efficiency in the whole process of an organization. This SOP software from Logicmind has a central and sheltered digital locker or a repository from which users can access the documents like SOP of the company with great ease. Logicmind software automatically steers and distributes the digital documents. SOPs are required by employees of the organization and it is an essential part of the system to maintain quality. You can use Logicmind-SOP Management Software to secure documents like policies & procedures, SOPs and work instructions and etc. Basic Pharmaceutical companies have about 1200 to 1300 SOPs and major objective of these are to enlighten the individuals about their responsibilities. With SOPs following objectives are highlighted in an organization:
With Logicmind you can upgrade your SOP software and adopt a digital SOP in your organization. The package has completely integrated applications and easy to use configurations to help small companies operate their system easily. Logicmind is web based SOP management software which makes all the operations easy within organisations like biotech companies, biologics developers, drug manufacturers, medical gadgets manufacturers or CRO’s.
At the present time, pharmaceutical sectors are the most regulated industries governed by numbers of laws. Guidelines related to the FDA, USFDA, MHRA, TGA and others are applied to ensure the safety and effectiveness of the medicinal products. Pharmaceutical companies are directly related to the human health. So, it is the prime concern to follow safety and environmental training along with cGMP rules. The training session not only cares about the health of employees, but also guarantees that processing is done as per the guidelines.
During most of the audit time, the basic training management system is found as the weakest link. The workers are unaware of the good manufacturing practices. Today’s challenge is to apply the training management system successfully in every industry.
What LogicMind Training Management Software does?
An achievement only lies in the way different variables are controlled and maintained by keeping a record. It can be in form of the document to CAPA and audit to CRO management.
Training session doesn’t only relate to induction training. It also involves learning through practice, introducing tools such as video and interactive tests. This all helps the employees to push their boundaries. Excel spreadsheet can be a good option, but it is not feasible because of:
By practicing the new techniques, any organization can achieve its goal of safety and maintain the consistency of the quality products.
Converting of your regular paper logbook with the electronic system is in the trend now. Most of the pharmaceutical companies are accepting the E-logbook for making the documentation and keeping the records in the simplest manner. The R&D team and quality control laboratories opt for this system in order to maintain Good Manufacturing Practice notebooks. LogicMind has developed a new way of electronic logbook system, which is perfect for the pharmaceutical industry.
Basically, E-logbook is regarded as a computer based software, which is meant for entering details, events and simple conditions. It is widely used by pharmaceutical industries. Purely, an intranet-based application, E-logbook makes use of electronic signatures and multi- tiered privilege levels along with stamped audit trains. This results in keeping the data integrity for legal and regulatory purpose.
Admit that, logbook maintenance is very time consuming and most of the pharma industries are not able to maintain the record. Therefore, the requirement of software is completed by E-logbook and has become an integral part of 11 complaints (21 CFR and Annex 11). For resisting the automation and stumbling block, GMP and Lab notebooks are regarded as the major part of pharmaceutical companies. The introduction of E-Logbook has finally broken the logjam while incorporating FDA Approved security best practices. This can be done by converting manual logbook completely into electronic system.
LogicMind is one sure shot solution who is providing an outstanding platform meant for implementing E-logbook. Therefore, our range is best for improving the productivity, compliance and minimizes the paperwork up to 100%. The product is the result of collaboration with major pharmaceutical companies. The function complies with different technical controls, which is required by US Food and Drug Administration.
|Manual logbooks make the working difficult as these are available in scattered form and become difficult for accessing.||With E-Logbook, all the data is saved on central database and can be refer whenever required.|
|Compliance and Accuracy|
Current Good Manufacturing Practice (cGMP) is the basic of every pharmaceutical industry. At the time of manufacturing of different food products, pharmaceutical and medical devices; the protocols play a very important part. The product management is perfect for safeguarding the health of participants and answer the specific research questions.
Change control is an efficient approach to control all changes made to a product or system in FDA-regulated and ISO-certified settings. To certify the quality and safety, the companies have to set up practices for change control software. It is mandatory for companies to maintain the documents to explain all the changes made in change control software. The objective is to ensure that no needless changes are made and resources are used in a proper manner.
With advanced change control software, all the changes can be updated automatically in the documents. It assures compliance and boost up the efficiency.
LogicMind has designed a CAPA system to aid you to conquer operational risks by realigning data and preventing errors. It goes beyond authoritarian FDA & ISO compliance and enables the organizations to deliver the best. Using this system allows the users to reduce the audit time and eliminate the threats of product recalls. The CAPA system ensures product quality and bolsters the trust of clients.
Quality concern of the products always remains the topic of discussion and it is also the important part of the manufacturing process. Several quality standards are already made that are followed by most of the industries. If quality is not there, most of the products would not be able to meet the desire results. Thus, they will become the complete junk.
The lack of quality, leads to deviation and it is very important for any manufacturing company to manage the deviations. Basically, it is defined as a measured difference present in between the observed value and the expected one. This report is required for a process or product conditions. There could be any possibility related to its occurrence. Mainly, it occurred at the time of sampling and testing of various raw materials and final products.
Thereof, it has become very important for managing the deviations at the time of development, manufacturing and distribution of different pharmaceutical companies. Note that, the deviation could also happen due to complaints of customers at the time when the standards do not meet with the critical attributes. The complaints can vary from:
To get the compliance with GMP, it is suggested to document all the procedures. According to the FDA § 211.192, the documents are studied and conclusion is made further.
Here, comes the role of Deviation management. This is especially designed for ensuring that the identified deviations should be recorded. Whatever be the incidents, the quality or reliability must be investigated properly and resolved.
Talking about the proactive approach, it has become a part of LogicMind known for offering full support in case of –
The reports related to deviation and remedial measure can be submitted anytime. The whole deviation process is well supported by the system starting from initiation to investigation. The final report should be in compliance with CFR 21 Part 11.
Gone the days when papers were used for doing every work. It is the new world with new technology. This is the time to go paperless and secure your work. Save your space and time by adapting Forms Management. Proven to be an effective solution, you can easily make use of electronic devices and digital equipments to swap your pile of papers. Join your hands with us, we will help you in managing all your unsecured data and make the easy accessibility of the documents whenever and wherever required.
Compared to the paper work, it sends the information to different departments and people within minimal time. Your handwritten paper passes through lots of hands and finally reaches the person that required it. Whereas, Forms Management helps you in directly providing the information to targeted person. From this, you can even share the confidential content. Forget about damaged, misplaced or losing your data. Save both time and money with this process and give a boon to your company.
Our service is best for editing and accessing the data without spending much time at the time you need the most. With fast pacing technology, people started relying on the electronic devices that increase the efficiency of the workflow. They also minimize the time required for approving the data as the whole information is available in front of you.
As your business is grows, most of the time you do not have time to take the quick decision. The electronic signature helps you in making the decision with the use of advanced mobile technology.
This can be done by using automated workflows that make use of Forms Management. The Forms Management service we offer, make you to focus more on the business tasks as it reduces the time spent on completing the paperwork. Overall, you will be able to manage your work timely.
It doesn’t stop here. You can easily fill the data in eForms without taking much time and simultaneously remove all the scanning process. Thus, the process becomes very fast. What’s next? You have the authority to combine all your eForms data with the document management system (DMS) automatically. This makes the editing easy and the resultant look is similar to the original paper.
As the paper usage is less, the overall cost would be low. Because, if you are using paper that means it also require printing, copying and the maintenance expenses in addition.
Why to waste your hard earned money? Go for Forms Management and minimizes the burden of using paper. Be a part of good cause and save the trees, save the Earth.
|Sl. No.||Brand||Product||Version||Certificate||Year of release|
|2||LogicMind||E-SOP/ SOP Management||1.0||Download||2017|
|3||LogicMind||E-Logbook / Log Book Management||--||--||--|
|5||LogicMind||Change Control Management||--||--||--|
|8||LogicMind||Document Management System||--||--||--|
|19||LogicMind||Contact list Management with Organogram||--||--||--|
|20||LogicMind||Job responsibility & Profile Management||--||--||--|