lims - revol software · document control is an important component of a quality system. revol lims...

ISO 17025

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Revol LIMS is a Single Solution - Entire Lab.

Revol Lims is a thin-client laboratory information management system (LIMS) which is tailored to manage an organization’s complete laboratory information to optimize the productivity and operating cost with increasing quality across the region.

Revol Lims takes you beyond the traditional LIMS by consolidating additional functionalities typically found in multiple laboratory systems into one product platform across the global enterprise in a simplified way.

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LIMSSINGLE SOLUTION – ENTIRE LAB

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Revol Key Features

Solid, Proven Technology

Built on the industry standard database (Microsoft SQL Server) Built on powerful Microsoft Dot Net, JQuery & JavaScript TechnologiesAdvanced Dashboards built using Visifire & Dundas chart controls Advanced Reports built in Crystal Reports and SSRS Reports

Revol LIMS is 100 % web-based system and easy to deploy, maintain, upgrade, and integrate into other ERP systemsRevol LIMS is scalable, flexible, open architecture. Easily tailored to meet the needs of both the small lab and large multi-site global operations

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Configurable Workflow

Global Online Access

Smart Scheduler

Out of Box Instrument Integration

Complete Audit Trail

Configurable Email Services

Data Integrity & Traceability

Configurable Alert & Reminder

Role Based Security (RBS) System

Real Time Statistical Analytics

Advanced Reporting

Data Export

Electronic Signature

Easy Integration to ERP Systems

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Architecture

Configurable Workflow

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A configurable workflow allows you to focus on only those process steps that are relevant to your sample lifecycle, allowing greater control over laboratory resources, without changing the way you work.

The Workflow lets you tailor LIMS behavior to define new statuses, create automatic transitions, or add new approval or signature steps as needed for your laboratory Processes

Revol LIMS Provides all the features required to manage the workflow and resources of the Lab. The workflow is completely configurable according to your lab requirement and consists of Sample Login, Sample Collection, Sample Delivery, Sample Receipt, Analysis Preparation, Sample Analysis, Result Entry, Result Validation, Result Approval and Result Authorization.

The hard work is already done for you. Revol LIMS platform is pre-configured for specific markets for out-of-the-box functionality, reducing implementation and support cost and lowering the total cost of ownership

Pre-configured for particular market segments, much of that work is already done for you.

A major part of today's Information Technology (IT) budgets is allocated to address integration, at the heart of which is the interfacing and interoperability between LIMS and other key business applications. Revol LIMS has got integration functionalities with ERP/MRP systems, thereby reducing costs.

Revol LIMS is a thin-client browser interface and has the familiar website look and feel. Thus its use is intuitive, which keeps initial and ongoing training costs low. Because end-users are more comfortable with the interface and adoption is easier, Revol LIMS can be integrated with the organization's workflows more quickly. This enables organizations to leverage their investment and reap the benefits of enhanced productivity sooner.


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TRAININGMANAGEMENT

REAGENT MANAGEMENT

Revol LIMS Modules

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INVENTORYMANAGEMENT

SAMPLEMANAGEMENT

ASSET MANAGEMENT

INSTRUMENT AUTOMATION

TASK MANAGEMENT

SPC / SQC

ELN ADHOC REPORTS

ESCALATION MANAGEMENT

STUDIES MANAGEMENT

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The state-of-the-art Revol Instrument Integrator include nearly all parsers and drivers out-of-the-box. Furthermore, the Revol Instrument Integrator is capable of capturing and processing more than just values. For simple instruments such as balances and pH meters, the system would need to be intelligent enough to associate results with metadata (units, samples, tests, etc.) to build context around the values collected. Additionally, for complex instruments such as chromatography data systems and blood analyzers, the Instrument Integrator would communicate bidirectional to deliver both protocols/requirements and parse results returned as files.

Revol LIMS state of art instrument connectivity enable to integrate instruments easy and quick. Instrument Integrator able to connect most of the laboratory instruments straight out of box with a powerful configuration tool and retrieve data from different file formats.

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Compliance - Authenticity and Traceability

Revol LIMS is in compliance with FDA, CAP, ISO 17025 requirements in all aspects like authenticity, Integrity authentication, traceability, non-repudiation, Complete Audit Trail... etc.

The major requirement of any regulatory section is E-Signature for electronic records, for closed systems (where access is controlled by the persons that are responsible for the content of the electronic records) including authenticity, integrity, confidentiality and non-repudiation. The requirements for open systems (like the Internet) cover electronic records from the point of their creation to the point of receipt and also call for authenticity, integrity and confidentiality, as well as additional measures such as encryption and digital signatures (defined as cryptographically-based).

Revol LIMS is designed to ensure the authenticity, integrity, and when appropriate, the confidentiality of electronic records from the point of their creation to the point of receipt, and as needed, additional measures such as document encryption and appropriate digital signature standards and to ensure that the signer cannot readily repudiate the signed record as not genuine.

Pre-Configured for Compliance with Water and EnvironmentalAdvanced interfacing to instruments and subsystems will improve automation and minimize errors, thereby resulting in higher quality and accuracy without further investments in supplementary solutions. Revol Instrument Integrator is supported by technologies that have already demonstrated their suitability in everyday use, therefore rendering its administration simple and effortless. By eliminating transcription errors and increasing user compatibility, Revol Integrator will improve efficiency in laboratories worldwide.

Compliance

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IntakeDataFDA21CFR Part 11, ISO 17025 NABL, CAP...etc.

Password PolicyVersion ControlAccess Control Policy Access Level PermissionData ValidationAudit Trail

Data Input ControlData Output (Print, Export)Data BackupData Archive Document ChecksumDocument EncryptionE-Signature

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Complying with ISO 17025

Revol LIMS Benefits For ISO 17025 Compliance

Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently

produce valid results. It is also the basis for accreditation from an accreditation body. Since the standard is about

competence, accreditation is simply formal recognition of a demonstration of that competence. A prerequisite

for a laboratory to become accredited is to have a documented quality management system. The usual contents

of the quality manual follow the outline of the ISO/IEC 17025 standard.

LIMS, short for a laboratory information management system, an essential data management and enterprise

integration tool for managing laboratory workflow, samples, reporting and compliance requirements. And, while

many in the oil and gas industry think of LIMS as a way to manage important data, it is, in fact, much more than

that. It is a catalyst that is part technology, part discipline and all-encompassing. In other words, when you think

of ISO 17025, don’t think compliance, think higher-quality product.

But certainly conforming to ISO 17025 standards is time-consuming, costly and technologically complex. Revol

LIMS covers everything from contract review to method validation and quality assurance. One does not simply

check a few boxes to stay in compliance; if it were that easy it wouldn’t be so beneficial in the long run. But getting

into compliance - and realizing the benefits of doing so - doesn’t need to be overly costly or time-consuming.


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ISO 17025 Management Requirements

Why Revol LIMS is Critical to ISO 17025 Compliance

Sections 4 and 5 of ISO 17025 are the primary areas of alignment between regulatory compliance and LIMS functionality. In fact, it is now possible to use Revol LIMS that is preconfigured for compliance; no additional programming or modules are required. For an onsite or third-party laboratory in the oil and gas industry, built-in functionality saves time, money and months of aggravation that can be associated with custom software development.

An integrated data management system, such as Revol LIMS, is designed to mitigate complexity, easing compliance within oil & gas laboratories and, most important, exposing previously unrecognized opportunities for performance improvement. Revol LIMS is purpose-built to align with each section of ISO 17025, especially “Management Requirements” and “Technical Requirements.”

• 4.1 Organization and ManagementLabs must not only meet standards within their own facilities, they are responsible for compliance at third-party facilities and temporary facilities — such as field-based labs — as well. To manage this level of complexity without disrupting daily activity, Revol LIMS uses a Web services architecture that is both secure and extensible.

• 4.2 Quality System ISO 17025 not only calls for documentation of quality systems and procedures, it requires that it “be communicated to, understood by, available to and implemented by” appropriate personnel. Revol LIMS system can be the conduit for quality system documentation and reinforcement.

• 4.3 Document ControlDocument control is an important component of a quality system. Revol LIMS can store relevant documents in nearly any standard format as an attachment, making compliance with document control a natural extension of routine laboratory work.

• 4.4 Review of Request, Tender or ContractAn oil and gas laboratory must demonstrate that it has the requisite experience, capabilities and resources to meet the requirements of the client. Because Revol LIMS offers a system-wide view of resources, methods, instrument calibration, etcetera, it plays an important role in the contract review process. Revol LIMS, for example, pulls in data from operator loading reports to provide real-time insight into operator workload and possible resource conflicts.

• 4.5 Subcontracting of Tests and CalibrationsISO17025 requires that laboratories are able to “demonstrate” that any subcontractor is “competent to perform the activities in question,” and that it is also in compliance with the standards. When using Revol LIMS, all this information is stored within comprehensive “supplier tables” for fast, universal access.

• 4.6 Purchasing Services and SuppliesLaboratories are responsible for the quality of all services and supplies that affect the quality of tests or calibrations. With Revol LIMS, all supplier statuses, including reagents and other consumables, are easily managed using “supplier management” entry screens that feed into real-time reports and dashboards.

• 4.8 ComplaintsISO 17025 requires that laboratories have policies and procedures in place to resolve complaints. With Revol LIMS, all this information is easily captured and stored within an incident summary, ensuring compliance and providing an historical record for avoiding such issues in the future.

• 4.11 Preventative ActionISO 17025 includes provisions for prevention, as well complaint resolution. This is one of places where the regulations align with Revol LIMS “best practices” capabilities.


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ISO 17025 Technical Requirements

• 5.2 PersonnelISO 17025 requires that laboratory management take full responsibility for the ongoing competency of all staff at all stages of testing and analysis. For this, Revol LIMS is particularly useful, not only for compliance, but also for ensuring that staff remain properly trained and certified.

• 5.4 Test and Calibration Methods Including SamplingISO 17025 requires that labs have easily accessible instructions for operation and handling of instruments and test samples, that all methods are appropriate and compliant/current and that personnel have the requisite experience to use the method. Revol LIMS stores up-to-date inventory and preparation records, usage and expiry data.

• 5.5 EquipmentISO 17025 makes it clear that all equipment must meet the required performance parameters for its stated use. To accomplish this, Revol LIMS maintains comprehensive records for each instrument, as well as each of its components and complete calibration history and status.• 5.7 – 5.9 Sampling Plan, Handling and Transport, Assuring the Quality of Test and Calibration ResultsISO 17025 requires that labs have defined procedures for sampling plans, handling and transportation of samples, as well as the management of calibration items and for ensuring the quality of results. With Revol LIMS it’s possible to create a sampling plan from a template that automates many of the necessary steps.

• 5.10 Reporting the ResultsNo laboratory would dispute the ISO 17025 requirement that each test or calibration it carries out should be reported “accurately, clearly, unambiguously and objectively.” Revol LIMS provides a powerful and flexible reporting tool that generates multiple reports from data stored within the system.

ConclusionISO 17025 compliance in the oil and gas industry isn’t easy, especially in labs still using paper-based processes, but for those labs that take a comprehensive approach the benefits are significant.

Compliance processes can be part of an integrated program that improves overall multi-facility performance and profitability. Whether an oil and gas laboratory starts with regulation as its impetus or simply wants to improve quality, the end result with Revol LIMS is the same: an integrated system that can deliver the best of both worlds. And, with systems pre-configured for the industry, getting up-and-running on the road to compliance and higher Performance is only a log-in screen away.


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• Can be accessed from anywhere

• Using Internet with no plug-ins, downloads or

applets

• Access is completely Role-based and

User-based pass word protected for security

• The benefit of this type of solution is that users

internal and external to the Business as well as

customers and vendors, can easily access the

information they need and to which they have

rights - anytime, from anywhere

• Data backup and restore is completely secured

100% Browser - Based Rich Functionality

Robust Configurability

Min. Risk & Max. AcceptanceLeverage Optimal ProcessesUpgrade CompatibilityReduce Cost of OwnershipExtends of Investment

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Competitive specific configurations continue to functionfollowing software upgrades.

Customers are empowered to extend/configure in-house

Useful life of investment is maximized

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Customer Support

Work with Revol Team with decades of experience in various industries. Revol Team can examine your existing workflow and business processes, identifies opportunities for improvement and builds the roadmap to optimize your lab's productivity and operating cost.

Customize the Business Suite you want in weeks and get implemented in a month time rather than in months or in years. Revol Business Suite is easy to configure and fine-tune to your terminology and process. User friendly menus and tables make it possible to quickly launch your system into production.

Validation-ready implementation. The existing rich functionality and feature set reduces the time needed to configure, test, and deploy the system. Little to no custom code needs to be developed for standard implementation. This lowers the overall project timeline and dramatically reduces the validation requirements.

Offers a comprehensive support program to make sure Customers keep getting the results they want, including:• 24/7 Online Support website • Phone support through local offices during regular business hours • Emergency response time of within one working hour, during regular support hours • Software installation support• Software Upgrade support

Expertise & Supports


20 Reasons For Revol Lims

Global Access - Complete Web Based TechnologyMeet Analytical, Life Science & Healthcare GMP, GLPCost Effective Solution for every individual labPaperless Laboratory ConceptTraceable Analysis ManagementSmart Analysis SchedulerEasy Instrument IntegrationEffective Resources UtilizationEfficient Sample ManagementOptimized Inventory ManagementHealthy Instrument ManagementComplete Document ManagementTraceable Escalation ManagementConfigurable Email, Alert & Reminder SystemManagement Dashboard Analytics (MIS)Advanced ReportingComplete Audit Trail & Version ControlMaintaining Data IntegrityStrong Data SecurityEasy Integration to other ERP


Website : www.revolsoft.comEmail : [email protected] : [email protected] : [email protected] : revol_softwarePhone : +91 - 4652 - 266243.

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Revol Benefits

lims - revol software · document control is an important component of a quality system. revol lims...

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