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Solution for Healthcare, Pharmaceutical, Life Sciences, Medical Devices,
Biotech, Clinical, CROs , Food and Chemical industries
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.
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 Logbook | E-Logbook |
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| Availability | |
| 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 | |
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| Productivity | |
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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.
Organizations use document control software to manage critical documentation in a more secure and efficient way. Companies in life sciences – including biotech, healthcare, pharmaceutical, and more – use it to simplify many burden some processes while staying compliant.
Document control is the process by which organizations manage documents from the point of creation to distribution and storage. It encompasses workflows that include your documents themselves, the protocols you’ve put in place to control them, and who gets to interact with them.
The manual ways of managing documents simply don’t cut it in today’s digital environment. Whether you use document control software on your premises or in the cloud, you’ll see the following benefits:
Document control software allows you to automate your standard operating procedures (SOPs) through workflows and demonstrate they’re being followed. An electronic training module allows you to automatically assign content/compliance based training by job title and produce training reports for auditors with the touch of a button. The technology enables you to prove that your sensitive documents are controlled properly and accessed by only the right people. When audit time comes around, the digital storage of your documents will help you retrieve the relevant ones instantly and organize the material needed to quickly collect data for the audit
Using a document control system enables your organization to lower overhead costs through several benefits. Your business will save time by not having to deal with manual, paper-based processes. With employees free from having to chase documents through workflows, they will get their day back and deliver efficiency through work instead of stagnating productivity. You’ll also see the cost-saving benefits of sustainability – with paper out of the picture, you’ll save on ink and all products related to paper processes.
Here’s what you can do with Logicmind Document Software.
The software streamlines review, approval, distribution, retrieval, and obsolescence processes for documents. You’ll gain revision control and revision history tracking while being able to enforce document standards. You’ll also be able to automate the periodic review of aging documents.
Enjoy easily searching for and finding documents come audit time. The software provides comprehensive audit trails and reports, and you’ll be able to quickly produce employee training records. If your industry requires FDA 21 CFR Part 11 compliant e-signatures, the software captures those as well and manages your entire audit process, assigning action items, and producing reports.
Logicmind Document Software enables controlled access to documents in a global workforce. People who have secure access to documents are always supplied with the most recent version – eliminating multiple communication channels and potentially wasted time with older documents. You keep peace of mind knowing your critical business data remains secure. There is no risk of physically losing documents, and your employees maintain access to files should a cyber attack or natural disaster occurs.
Version control manages and tracks the changes made to content. It ensures the availability of the most up to date, approved and current content. As both content and procedures or processes change, resulting updates must be reflected in any document management software system. If changes are pending and have not yet been approved, the content should only be available to certain users. Logicmind tracks who makes changes and when, and also tracks the reviews and approvals. This version control or revision process determines what is the most current content which should be made available and to whom. The levels of visibility and access are determined through the configuration of security for each user within Logicmind. Logicmind controls who is able to see and work with the proper version. Previous versions remain in the system, visible only to those with the proper rights. End user also gives you time stamps and a signature on any updates as they go live. In layman’s terms, you’ll be able to backtrack to see who implemented what new changes and when.
Logicmind Document Software offers Standard Operating Procedures, Protocol Management, Specification Management, Policy Management, Quality Manual Management, LIF/SMF, MRM…
Specification management is the practice of standardizing your specifications in a centralized system where you can control and approve the values and inputs of your specs through structured data and automate the review, approval and distribution processes of specs to stakeholders.
The purpose of specification management software is to streamline the creation, collaboration, review, approval, and distribution of your specifications and automate the parts of your processes that are highly manual and prone to human error. Establishing one centralized platform for managing your specifications and other critical business documents gives you the power to implement standards across your organization and align different departments to maximize efficiency, save money, and ensure compliance.
Create Specifications: Create specs with electronic forms where you can structure your data with controlled, approved values.
Searching: Search with precision at the field level. Automate Review & Approval: Aurmatic routing that will notify stakeholders by email when they have a spec to review or approve in the system
Security: Security model that supports control over who can do what, to which content.
Notifications: Automated email notifications to the stakeholders when specs and docs become effective.
Report: Create different PDF or Excel reports for different audiences.
The Logicmind Specification Management Software is a comprehensive system for creating, maintaining and publishing your specifications and business documents. The browser-based system is available on-premises. Fully integrated with our document management features, the software allows for complete control over who can access which documents and tracks all activities with the ability to create reports for visibility and compliance. Logicmind’s version control features guarantee that your employees and suppliers are always working from the correct version of a spec or document. The system integrates with your email client to send email notifications to the stakeholders at each step of the workflow, improving collaboration and increasing the efficiency of your processes.
Policy management is the creation, implementation and maintenance of policies within an organization. Policy management software handles complex policies effectively which helps organizations centralize policies into one accessible place, facilitates stakeholder involvement, shares knowledge and information efficiently, keeps policies relevant and compliant and creates an audit trail. The benefits of policy management software include:
Today, nearly all departments in any organization need Policy Management software. Why? Because the largest risk of reputational brand damage, lawsuits, or regulatory fines comes from your own employees. Well-managed and enforced policies and procedures will help, but ensuring they’re maintained, distributed, and attested to?
Finding the right policy management software to fit into your company’s GRC framework can be a challenge, which is why Logicmind solution is specifically designed to integrate seamlessly with any existing systems, as well as help you build out a new compliance program. The benefits to your leadership, employees, and organization as a whole, present and future are endless.
Generate significant (and quick) ROI through process automation and automated notifications – reducing human error, delays, and costs
Demonstrate a culture of ethics and compliance by being able to provide full audit trails and reporting including your policy handbook.
Fines and reputational damage can make noncompliance costs 3 times higher than the cost of remaining compliant.
Through built-in best practice tools, remove the complexities of policy management with end-to-end policy life-cycle management.
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.
Customer success is ours
| 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 | -- | -- | -- |
| 4 | LogicMind | Protocol Management | -- | -- | -- |
| 5 | LogicMind | Change Control Management | -- | -- | -- |
| 6 | LogicMind | CAPA Management | -- | -- | -- |
| 7 | LogicMind | Deviation Management | -- | -- | -- |
| 8 | LogicMind | Document Management System | -- | -- | -- |
| 9 | LogicMind | Forms Management | -- | -- | -- |
| 10 | LogicMind | Market Complaints | -- | -- | -- |
| 11 | LogicMind | Investigation | -- | -- | -- |
| 12 | LogicMind | Risk Assessment | -- | -- | -- |
| 13 | LogicMind | Customer Complaints | -- | -- | -- |
| 14 | LogicMind | Non-conformance | -- | -- | -- |
| 15 | LogicMind | Submissions Gateway | -- | -- | -- |
| 16 | LogicMind | Compliance Management | -- | -- | -- |
| 17 | LogicMind | Audit Management | -- | -- | -- |
| 18 | LogicMind | Task Management | -- | -- | -- |
| 19 | LogicMind | Contact list Management with Organogram | -- | -- | -- |
| 20 | LogicMind | Job responsibility & Profile Management | -- | -- | -- |