LN Compliance: Revolutionizing QMS Preparation with AI/ML/NLP Tools

Are you tired of the painstaking and time-consuming process of Quality Management System (QMS)
documentation? LN Compliance is your answer—a sophisticated software empowered by AI, ML, and
NLP technologies, designed to simplify QMS preparation in minutes.

1. Streamlined Documentation: With LN Compliance, the tedious task of QMS documentation, which
typically consumes a quarter of an employee's time, is significantly expedited. The software automates
the complex and resource-intensive documentation process, saving precious time for your workforce.

2. Intuitive Keyword-Based Operation: Prepare hefty documents effortlessly. LN Compliance allows

users to generate comprehensive QMS documents using simple and relevant keywords. Say goodbye to
hours of manual work; let AI and NLP do the heavy lifting for you.

3. Workforce Efficiency: Achieve more with fewer resources. LN Compliance's efficiency-driven

approach reduces the need for an extensive workforce dedicated to QMS tasks, ensuring cost savings
and improved operational productivity.

4. Flawless Grammar and Formatting: Leave the intricacies of grammar, standard formatting, and
proper documentation to LN Compliance. Your QMS documents will be error-free, professionally
formatted, and compliant with industry standards.

5. User-Friendly Data Handling: Even for data and tools unfamiliar to employees, LN Compliance
empowers users to harness their potential. The software's intuitive interface allows you to achieve
fruitful outcomes by simply inputting relevant keywords.

6. Cutting-Edge Security: Trust in ultimate privacy. LN Compliance employs state-of-the-art blockchain

technology to encrypt your data, ensuring that your sensitive information remains protected and secure.
Enjoy peace of mind, knowing that your documents are safeguarded at every step.

Experience the future of QMS documentation with LN Compliance. Elevate your compliance strategy,
save time, reduce costs, and enhance the efficiency of your workforce—all with a solution that's user-
friendly, secure, and expertly crafted to meet your needs. Welcome to the future of QMS management;
welcome to LN Compliance.

7. Helping out SME manufacturer with Quality systems which they cant prepare.

8. Consultant for following lean management system such as six sigma,TPM,TQM etc.

9. Multiple stakeholder will prepare this or review this document simultaneously where traditional
process is circulating document one by one iterating and revising it multiple times.
 Documents that we aim to prepare in Pharma Industry.

Term Definition

A defined quantity of a drug product that is intended to be uniform and produced according to a single
1. Batch manufacturing process or procedure.

2. GMP (Good
Manufacturing A set of regulations and guidelines that ensure the quality and consistency of pharmaceutical products
Practices) during their manufacturing, testing, and distribution.

The process of testing and inspecting pharmaceutical products to ensure they meet established quality
3. Quality Control (QC) specifications.

4. Quality Assurance The systematic process of ensuring that pharmaceutical products are manufactured and controlled to
(QA) meet the quality standards set by regulatory authorities.

5. Standard Operating Detailed, written instructions that outline how specific processes or activities should be performed within
Procedure (SOP) a pharmaceutical facility to ensure consistency and quality.

The process of establishing documented evidence that a system, equipment, process, or method
6. Validation performs as intended and consistently produces the desired results.

7. Change Control A formal system for requesting, documenting, evaluating, and implementing changes to processes,
 Term Definition

equipment, or materials to ensure product quality and safety.

Any deviation from established procedures or specifications that can affect product quality, safety, or
8. Non-Conformance efficacy.

9. Root Cause Analysis A systematic process for identifying and addressing the underlying causes of non-conformances or
(RCA) quality issues.

10. Corrective and

Preventive Actions A systematic approach to identifying, addressing, and preventing issues or deviations in the
(CAPA) pharmaceutical manufacturing process.

An unplanned or uncontrolled departure from standard operating procedures or specifications that can
11. Deviation impact product quality or safety.

The process of evaluating and quantifying potential risks and hazards associated with pharmaceutical
12. Risk Assessment processes or products.

A systematic examination and evaluation of a pharmaceutical facility or process to ensure compliance

13. Audit with regulatory requirements and internal standards.
 Term Definition

14. Documentation The management and control of all documents related to pharmaceutical operations, including policies,
Control procedures, records, and reports.

15. Quality Risk The systematic process of assessing and managing risks to the quality of pharmaceutical products
Management throughout their lifecycle.

16. Critical Quality The key physical, chemical, biological, or microbiological properties or characteristics that must be
Attributes (CQAs) controlled within predefined limits to ensure the quality of a pharmaceutical product.

17. Regulatory Adherence to the laws, regulations, and guidelines established by regulatory authorities such as the FDA,
Compliance EMA, and others.

A formal agreement between a pharmaceutical company and a supplier or contractor that defines each
18. Quality Agreement party's responsibilities for maintaining product quality.

19. Change A systematic approach to managing and controlling changes to processes, systems, and documentation
Management within the pharmaceutical organization.

20. Out of Test results that fall outside the established acceptance criteria for a pharmaceutical product, indicating
Specification (OOS) a potential quality issue.
 Term Definition

Strategies and actions taken to reduce or eliminate identified risks to the quality, safety, or efficacy of
21. Risk Mitigation pharmaceutical products.

22. Quality Control A documented plan that outlines the specific quality control tests and inspections to be performed at
Plan different stages of pharmaceutical production.

23. Good Laboratory Regulations and guidelines that ensure the integrity and reliability of non-clinical laboratory studies in
Practices (GLP) the pharmaceutical industry.

The science and activities related to the detection, assessment, understanding, and prevention of
24. Pharmacovigilance adverse effects or any other drug-related problems.

A reference book or official publication containing a collection of standards and specifications for
25. Pharmacopoeia pharmaceutical substances and products.

26. Master Batch A comprehensive document that provides detailed instructions for the manufacturing of a specific batch
Record of a pharmaceutical product.

27. Quality
Management Review A periodic review of the pharmaceutical company's QMS to assess its effectiveness and identify areas for
(QMR) improvement.
 Term Definition

28. Risk Assessment A tool used to evaluate and prioritize risks based on their likelihood and potential impact on product
Matrix quality and safety.

29. Supplier The process of evaluating and ensuring the competence and reliability of suppliers of materials,
Qualification components, or services to the pharmaceutical industry.

The monitoring and control of critical parameters during the manufacturing of pharmaceutical products
30. In-Process Control to ensure product quality.

A formal statement that outlines the pharmaceutical company's commitment to quality and its approach
31. Quality Policy to achieving and maintaining high-quality standards.

32. Equipment A process to ensure that pharmaceutical manufacturing equipment meets defined requirements and
Qualification operates within acceptable limits.

33. Design A process to establish that the design of pharmaceutical manufacturing equipment or systems is
Qualification (DQ) suitable for its intended purpose.

The systematic collection and evaluation of data to demonstrate that a pharmaceutical manufacturing
34. Process Validation process consistently produces a product that meets predetermined quality specifications.
 Term Definition

A planned set of controls, including specifications, processes, and procedures, that ensures the quality of
35. Control Strategy pharmaceutical products.

A controlled environment with a low level of pollutants and a defined level of air cleanliness used for
36. Cleanroom pharmaceutical manufacturing.

37. Inspection The state of being prepared and compliant with regulatory requirements for inspections by health
Readiness authorities.

Ensuring the accuracy, reliability, and completeness of data throughout its lifecycle in pharmaceutical
38. Data Integrity operations.

39. Quality Risk A systematic evaluation of the risks associated with pharmaceutical products and processes, aiming to
Assessment identify potential issues and mitigate them.

40. Qualification A documented plan that outlines the steps and procedures for the qualification of equipment, systems,
Protocol or processes in pharmaceutical manufacturing.

41. Electronic Batch A digital record that captures and documents all relevant information related to the manufacturing of a
Record (EBR) pharmaceutical batch.
 Term Definition

42. Failure Mode and A structured approach to identify and prioritize potential failure modes and their impact on
Effects Analysis (FMEA) pharmaceutical processes or products.

The department responsible for ensuring that pharmaceutical products comply with all applicable
43. Regulatory Affairs regulatory requirements.

The period during which a pharmaceutical product is expected to remain within its specified quality and
44. Shelf Life safety parameters when stored under defined conditions.

45. Quality Control A professional responsible for conducting quality control tests and analyses to ensure the quality of
Analyst pharmaceutical products.

The overarching structure of policies, procedures, processes, and resources that a pharmaceutical
46. Quality System company uses to achieve and maintain quality objectives.

47. Regulatory The process of preparing and submitting documentation to regulatory authorities for product approval,
Submission registration, or marketing authorization.

The process of examining and evaluating data and results to identify trends, anomalies, or potential
48. Data Review issues related to pharmaceutical quality.
 Term Definition

A process to determine how the quality of a pharmaceutical product changes over time and under
49. Stability Testing various environmental conditions.

A documented list of identified risks, their descriptions, assessment, and mitigation plans in
50. Risk Register pharmaceutical manufacturing and quality control.

51. Quality Risk A document that outlines the strategies and processes for identifying, assessing, and controlling
Management Plan risks to pharmaceutical product quality.

52. Cleaning A process to ensure that equipment and facilities used in pharmaceutical manufacturing are
Validation effectively cleaned to prevent cross-contamination.

53. Quality by Design A systematic approach to product development and manufacturing that focuses on ensuring
(QbD) quality is built into the product from the beginning.

54. Regulatory Affairs A professional responsible for managing interactions with regulatory agencies and ensuring
Specialist compliance with regulations.

55. Data Integrity An assessment to confirm that electronic records and data in the pharmaceutical industry are
Audit maintained securely, accurately, and consistently.
 Term Definition

56. Quality Control A facility equipped for testing and analyzing pharmaceutical products to verify their quality and
Laboratory safety.

57. Critical Process

Parameters (CPPs) Key variables in a manufacturing process that must be controlled to ensure product quality.

58. Electronic
Document
Management System A software system used to create, store, manage, and retrieve electronic documents and records
(EDMS) in a controlled and compliant manner.

Testing pharmaceutical equipment while it is in operation to ensure it meets quality and

59. In-Use Testing performance requirements.

60. Analytical Method The process of confirming that a particular analytical method used in pharmaceutical testing is
Validation suitable for its intended purpose and produces reliable results.

61. Pharmacokinetics The study of how the body processes pharmaceutical products, including their absorption,
(PK) distribution, metabolism, and excretion.

62. Pharmacodynamics The study of the effects of pharmaceutical products on the body, including their mechanisms of
(PD) action and therapeutic effects.
 Term Definition

Key performance indicators used to measure and evaluate the effectiveness of a pharmaceutical
63. Quality Metrics company's quality management system.

64. Quality Risk A document that outlines the strategies and processes for identifying, assessing, and controlling
Management Plan risks to pharmaceutical product quality.

65. Quality Target A comprehensive summary of the quality characteristics of a pharmaceutical product that align
Product Profile (QTPP) with the intended use.

66. In-Process The practice of collecting samples of a pharmaceutical product during various stages of
Sampling production for testing and analysis.

67. Comparator A reference product used in clinical trials to compare the safety and efficacy of a generic or
Product biosimilar pharmaceutical product.

68. Regulatory A comprehensive collection of documents and data submitted to regulatory agencies for
Submission Dossier product approval, including the Common Technical Document (CTD).

69. Environmental The process of continuously assessing and controlling the quality of air and surfaces within
Monitoring pharmaceutical manufacturing facilities to prevent contamination.
 Term Definition

70. Product Lifecycle A system and process for managing the entire lifecycle of a pharmaceutical product, from
Management (PLM) development through manufacturing and beyond.

71. Compendial Testing performed on pharmaceutical products to ensure they meet the standards and
Testing specifications outlined in official pharmacopeias.

72. Critical Material The key characteristics and properties of raw materials used in pharmaceutical manufacturing
Attributes (CMAs) that can impact product quality.

73. Quality Software tools and systems designed to support and streamline the management of quality
Management Software processes and documentation in the pharmaceutical industry.

The process of submitting applications, reports, and other documents to regulatory authorities
74. Regulatory Filing for the approval and registration of pharmaceutical products.

75. Stability Storage The specific temperature, humidity, and light conditions under which pharmaceutical products
Conditions are stored during stability testing.

A formal agreement between a pharmaceutical company and a supplier or contractor that

76. Quality Agreement defines each party's responsibilities for maintaining product quality.
 Term Definition

77. Laboratory
Information
Management System Software used to manage and streamline laboratory operations and data in the pharmaceutical
(LIMS) quality control laboratory.

78. Health Authority An official inspection of a pharmaceutical manufacturing facility conducted by a regulatory
Inspection agency to assess compliance with GMP and other regulations.

79. Process Analytical A system for designing, analyzing, and controlling pharmaceutical manufacturing processes
Technology (PAT) through real-time monitoring and feedback.

80. Design of A statistical methodology used in pharmaceutical research and development to optimize
Experiments (DOE) processes and identify critical variables.

81. Reference A substance used as a standard of quality in pharmaceutical testing, ensuring the accuracy and
Standard reliability of test results.

82. Pharmacopoeial A detailed official description of a pharmaceutical substance or product's quality standards as
Monograph outlined in a pharmacopeia.

83. Certificate of A document provided by a pharmaceutical manufacturer that certifies the quality and
Analysis (CoA) composition of a specific batch of a product.
 Term Definition

84. Failure The process of analyzing and resolving failures, deviations, and non-conformances in
Investigation pharmaceutical manufacturing.

85. Process Validation A document that outlines the strategy for conducting process validation activities in the
Master Plan pharmaceutical manufacturing process.

86. Technology The process of transferring knowledge, processes, and equipment from one site to another
Transfer within a pharmaceutical company or to a different organization.

87. Regulatory The process of gathering, analyzing, and interpreting regulatory information to stay informed
Intelligence about changes in regulations and guidelines.

88. Design History File A collection of documents, records, and other information that demonstrates the design and
(DHF) development of a medical device, if applicable to pharmaceuticals.

89. Good Distribution Guidelines and regulations that ensure the quality and integrity of pharmaceutical products
Practice (GDP) during their distribution and transportation.

90. Risk-Based An approach to quality management in the pharmaceutical industry that focuses resources and
Approach efforts on areas of highest risk to product quality and patient safety.
 Term Definition

91. Good
Documentation Guidelines and practices for creating, maintaining, and controlling documents in the
Practices (GDocP) pharmaceutical industry.

A report generated by regulatory authorities following an inspection of a pharmaceutical facility,

92. Inspection Report summarizing findings, observations, and recommendations.

93. Batch Record The process of reviewing and approving all documentation and records related to a
Review pharmaceutical batch before it is released for distribution.

94. Return Material A documented process for handling the return of pharmaceutical products or materials from
Authorization (RMA) customers or distributors.

An observation of data or test results that deviates from expected trends or patterns, indicating
95. Out of Trend (OOT) a potential quality issue.

The values, beliefs, and behaviors within an organization that support a strong commitment to
96. Quality Culture quality and adherence to QMS principles.

An evaluation and assessment of a supplier's quality management system, facilities, and

97. Supplier Audit processes to ensure they meet quality and regulatory requirements.
 Term Definition

An analysis to determine the potential consequences and effects of a change, deviation, or non-
98. Impact Assessment conformance on product quality and patient safety.

99. Material Review A committee responsible for evaluating and making decisions about non-conforming materials
Board (MRB) or products in the pharmaceutical industry.

The unique identification and tracking of individual units of pharmaceutical products to enhance
100. Serialization traceability and combat counterfeiting.
 A documented list of identified risks, their descriptions, assessment, and mitigation
101. Risk Register plans in pharmaceutical manufacturing and quality control.

102. Product Quality Review A structured review of product quality data, including manufacturing and testing data,
(PQR) to assess the quality of pharmaceutical products.

A measure of a process's ability to consistently produce products that meet predefined

103. Process Capability quality specifications.

A formal document outlining the principles, standards, and practices for maintaining
104. Data Integrity Policy the integrity of data in the pharmaceutical industry.

The classification of cleanrooms based on the number and size of airborne particles
105. Cleanroom Classification permitted per cubic meter in the environment.

106. Process Validation A documented plan outlining the procedures and criteria for conducting process
Protocol validation in pharmaceutical manufacturing.

The manufacturing of pharmaceutical products under sterile conditions to prevent

107. Aseptic Processing contamination and maintain product quality.

A publication where proposed revisions to pharmacopeial standards are made

108. Pharmacopeial Forum available for public comment and discussion.

A document outlining the procedures and conditions for conducting stability testing
109. Stability Protocol on pharmaceutical products.

A comprehensive document that provides information about the pharmaceutical

110. Site Master File manufacturing site, its facilities, and operations.
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