White Papers

You can find whitepapers published by Agaram.

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How Logilab SDMS helps Laboratories to enable 21 CFR Part 11 Compliance – Part 1

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). In Part 1, the fundamental concepts of 21 CFR Part 11 and its vital requirements as applicable to Computerized systems in food and drug laboratories and manufacturing are discussed

How Logilab SDMS helps Laboratories to enable 21 CFR Part 11 Compliance – Part 2

In Part 2, overview of Logilab SDMS and its importance in 21 CFR Part 11 as applicable to Computerized systems will be described. Agaram Technologies’ Logilab SDMS is a generic software application designed to handle scientific instrument data from any analytical instrument and can facilitate data management with access control. 

How Logilab SDMS helps Laboratories to enable 21 CFR Part 11 Compliance – Part 3

In Part 3, how Logilab SDMS helps organizations to fulfil 21 CFR Part 11 requirements. Logilab SDMS is a closed system.  Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

How Logilab SDMS helps Laboratories to enable Eudralex Annex 11 Compliance – Part 1

In Part 1 of the whitepaper, the fundamental concepts of Eudralex Annex 11 and its vital requirements as applicable to Computerized systems in the regulated food and medical products industry are discussed. Eudralex Volume 4 consists of three Parts and a series of nineteen Annexes.  Within Part 1 of the standard, guidelines pertaining to Documentation are presented in Chapter 4.  Moreover, Annex 11 included guidelines for the use of computerized systems within GMP-regulated activities.  When used in conjunction with Chapter 4, Annex 11 provides guidance for the use of electronic documents (electronic records and electronic signatures) within the GMP environment

How Logilab SDMS helps Laboratories to enable Eudralex Annex 11 Compliance – Part 2

In Part 2,  the overview of Logilab SDMS and its importance in Eudralex Annex 11 as applicable to Computerized systems are discussed.  Agaram Technologies’ Logilab SDMS is a generic software application designed to handle scientific instrument data from any analytical instrument and can facilitate data management with access control. 

How Logilab SDMS helps Laboratories to enable Eudralex Annex 11 Compliance – Part 3

In Part 3, we looked into how Logilab SDMS fulfils the requirements of Eudralex Annex 11. In this part, we have mapped applicable Eudralex Annex 11 requirements with Logilab SDMS Solutions/Features

How Qualis LIMS helps Laboratories to fulfill ISO 15189 requirements

ISO 15189 is an international standard, deals with the important aspects and processes in a medical laboratory such as arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, interpretation and reporting of results, etc. This whitepaper discusses how Qualis LIMS helps laboratories to fulfil ISO 15189 requirements.

GxP Data Integrity for Cloud Apps – Part 1

GxP is a set of regulations and quality guidelines formulated to ensure the safety of life sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution.  In Part 1, the basic concepts of GxP requirements and Cloud implementation of computerised systems are discussed

GxP Data Integrity for Cloud Apps – Part 2

In Part 2, the strategies to be adopted by Organisations implementing cloud systems to comply with GxP requirements are discussed.

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