Lean Process Improvements for the GMP Laboratory
|
|
- Pauline Matthews
- 8 years ago
- Views:
Transcription
1 Lean Process Improvements for the GMP Laboratory
2 ITRODUCTIO Pharmaceutical manufacturing costs the industry approximately $90 billion each year and represents twice the expenditure of research and development. 1 A 2001 study conducted by the MIT Pharmaceutical Manufacturing Initiative (PHARMI) indicated that significant time was spent conducting quality control (QC) testing and documenting QC results during the manufacturing process. 2 Eroding profit margins from stiff competition, increasing product defects, 1,3 and the FDA s focus on a quality by design model has led the industry to reevaluate manufacturing efficiency. Recently, the industry has begun adopting both Lean Manufacturing and Six Sigma to achieve the efficiency and quality gains achieved by other industries. 4-6 IT solutions will play a significant role in managing QC standard operating procedure (SOP) documentation during the focus on Lean and Six Sigma to eliminate waste, improve workflows, improve quality, and reduce variability. QC operations represent an expensive component of the manufacturing process. GMP regulations require maintaining thorough documentation to ensure strict compliance with established SOP s during product testing. Thus, maintaining documentation using paper dramatically increases QC result turnaround time. Hence, completing paper documents and ensuring their authenticity creates a burdensome bottleneck in the QC laboratory. Electronic SOP form and worksheet systems, like Waters ugenesis SDMS Intelligent Procedure Manager, present an opportunity to create a semi-automatic Lean Process during the SOP documentation, thereby boosting productivity and accuracy in this largely labor-intensive component of the QC testing laboratory. 2
3 BOTTLEECK IDETIFICATIO The MIT Pharmaceutical Manufacturing Initiative identified QC testing and documentation as taking up a significant portion of total manufacturing time. 2 Relocating some QC testing to the manufacturing floor represents one solution to the testing lag time and Process Analytical Technology (PAT) represents a tangible solution for real-time testing. Additionally, the pharmaceutical industry s adherence to GMP FDA regulations such as 21 CFR Part 11, requires authentic, accurate, and complete recordkeeping. The regulations pertaining to documentation apply to the entire manufacturing process. When paper-based systems are used, this creates a major bottleneck during the QC testing process because every aspect of the testing requires documentation. Many QC laboratories employ a mixture of electronic data systems and paper. For example, chromatography data systems (CDS) manage the separation experiments and the Laboratory Information Management Systems (LIMS) handle the testing requests and result collection; while paper forms and notebooks capture instrument calibrations, solvent preparation, and other SOP s. The combination of electronic and paper systems results in a disjointed data and documentation process, where data are not readily accessible for real-time process monitoring. This disjointed process directly impacts product quality, variability, and QC turnaround time. Bottleneck resolution An electronic SOP documentation system offers the opportunity to address the three major tenets of Lean Process manufacturing: eliminate waste, improve workflows, and improve quality. To address the three tenets of Lean Process manufacturing, an electronic system must include the following properties: n Compliant-ready to fulfill 21 CFR Part 11, Annex 11 and electronic records requirements to ensure that electronic records are equivalent to paper documents. n Intelligently guide an analyst through laboratory workflows to ensure SOP fidelity. n Interface with common laboratory instruments and systems (balances, ph meters, CDS, LIMS, etc.) to eliminate transcription errors and duplication of efforts. n Capture both document and instrument data into one searchable location to aid searching. n Perform automated calculations in a 21 CFR Part 11 compliant-ready shell to reduce errors and maintain quality. Figure 1 illustrates a simplified workflow highlighting the interface between a LIMS and laboratory instruments with the electronic SOP system. A system comprised of compliant-ready, intelligent SOP s, system inter-operability, and database warehousing offers the potential to streamline the QC documentation process. GMP lab space Manufacturing Line Laboratory Information Management System (LIMS) Laboratory Instruments Figure 1. The GMP laboratory space. An electronic SOP system directly interfaces with test requests arising from a LIMS and with laboratory instrumentation to efficiently conduct and document GMP laboratory testing. System interfacing and professional services Scripted interface Electronic SOP System Data Document Database QC laboratories contain a heterogeneous mixture of laboratory instruments and data management systems. Hence, QC data and results exist in multiple electronic systems that complicate workflows. Lean Process manufacturing demands easy access to QC test results in order to control quality throughout the manufacturing process. Therefore, data exchange between electronic systems is a primary concern for QC operations implementing Lean Process manufacturing. Direct exchange of information between information systems is highly desirable, but due to the multi-vendor landscape of QC operations and the complexity of the electronic systems, a direct link is often not feasible. Hence, exchange of information between systems is often accomplished by utilizing an import/export interface utility. While a manual input/output may be useful for occasional data exchanges, a more automated approach that maintains compliance is necessary. Many IT solutions provide a procedural scripting utility for conducting automated data exchange and procedural operations such 3
4 as performing statistical calculations and trending. Writing scripts can be challenging especially while maintaining compliance, so many solution providers provide professional services to write automation and interface scripts. Waters offers professional services for systems such as Empower and ugenesis SDMS to facilitate workflow optimization, system validation, and system-to-system interfacing. VALUE STREAM MAPPIG The first step in developing a Lean GMP Laboratory Process is to map out the current state. The current state process map serves to establish a clear view of the process bottlenecks and acts as a baseline to track future process improvements. Figure 2 illustrates a current and future state process map for a Laboratory. Current Paper-based laboratory Paper-based laboratory LIMS LIMS Test Test CDS CDS Select SOP Select SOP ph Meter ph Meter Assign Test Assign Test Conduct Test Conduct Test Electronic Balance Electronic Balance Capture & Catalog Analytic Data Other Instruments Other Instruments Capture & Catalog Analytic Data Generate COA Generate COA Finalize SOP Document Finalize SOP Document Testing Complete Testing Complete Return Return Solvents Standards Reagents Solvents Standards Reagents Futrue Laboratory Laboratory SDMS SDMS LIMS LIMS Test Test CDS CDS Select SOP Assign Test Select SOP Conduct Test Instrument fit-for use inventory ph Meter Instrument fit-for use inventory ph Meter Assign Test Electronic Balance Electronic Balance Conduct Test Scripted/intelligent interface Generate COA Other Instruments Other Instruments Figure 2. A value stream map highlighting the current state QC laboratory documentation process that includes a mixture of manual processes, paper documentation, and electronic systems. The future state replaces manual system interfacing and documentation with an electronic SOP system to streamline QC testing and information capture. 4 Generate COA Capture & Catalog Finalize SOP Analytic Data Document Scripted/intelligent interface Scripted/intelligent interface Capture & Catalog Finalize SOP Analytic Data Document Reagent inventory Testing Complete Testing Complete Return Return Solvents Standards Reagents Scripted/intelligent interface Reagent inventory Solvents Standards Reagents
5 Detailed analysis of the current state map may provide a toplevel view of inputs and outputs, bottlenecks, sources of error and variability, and provide an indication of the complexity of the process. The future state process map in Figure 2 illustrates compartmentalization of the laboratory process into three parts: LIMS, an SOP electronic documentation system, and the analytical instrumentation. This new process organization allows the highly-skilled analyst to focus on conducting analytical testing, while the LIMS and/or SOP electronic documentation system handles the non-value added paper and data management. FLOW CHART MAPPIG Figure 3 illustrates a detailed workflow covering a single analytical test and highlights an HPLC dissolution workflow. Each rectangle in the flowchart represents a documentation step. This workflow consists of 10 documentation steps and a report step with content consolidated from the documentation steps, plus test results. This HPLC dissolution workflow demonstrates the degree of documentation required to conduct a relatively straightforward test such as dissolution in a compliant laboratory. To further demonstrate the documentation burden, consider that QC laboratories may also conduct UV based dissolution, content uniformity, assay, and impurity testing. Hence, all of these tests require approved SOP forms as well as complete and accurate documentation during testing to ensure compliance. An electronic SOP system captures all necessary documents and guides the analyst through the testing workflow, while managing necessary system interfaces. Start Mobile Phase? Prepare Mobile Phase Solvent Mixture? Prepare Solvent Mixture Standard? Prepare Dissolution Bath Internal Standard? Prepare Internal Standard Solution Prepare Standard Setup HPLC Standard Stock Solution? Run on HPLC Ready? Prepare Standard Stock Solution Prepare Set Complete? Plot Report End Figure 3. Flowchart of HPLC dissolution workflow. The diamonds represents decision points within an electronic SOP system, and the rectangles represent documentation events. This workflow consists of 10 documentation steps. 5
6 ERROR PROOFIG PROCEDURES Go to ext Step Prerequisites Solvent bottle: Bottle volume Mobile Phase? Mobile phase 1000 ml Figure 4 demonstrates the initial step from the HPLC dissolution workflow shown in Figure 3. If the analysts need to prepare a mobile phase, they are methodically guided through the preparation protocol. The prerequisite step directs the analyst to obtain the necessary solvent bottle and then Step 1 confirms that the solvents are available by interfacing with a reagent inventory system and automatically logs them into the worksheet. Step 2 provides the mobile phase preparation protocol. Intelligent Guidance Step 1 Description: Locale water, methanol, and glacial acetic acid from inventory and record identifying information. Component Batch no. Source Expire date Water Methanol Glacial acetic acid Step 2 Description: Prepare the mobile phase by mixing, methanol, and glacial acetic acid in a ratio of 69:28:3. (See table for required volumes of each). ote: For safety, add the acid last. Solvent Volume Units Water 690 ml Methanol 280 ml Glacial acetic acid 30 ml Figure 4. First documentation step in a HPLC dissolution study. Enforced workflow and automated interfacing to reagent inventory systems provides a method for error proofing the QC documentation process. 6
7 BUILDIG WORKSHEETS WITH A FORM DESIGER Some manufacturing processes utilize a jig apparatus to boost productivity and add precision to repetitive jobs. A common example of a jig is used during house key duplication. This jig provides rapid and accurate key duplication. In the same manner, SOP forms ensure that information is accurately and rapidly recorded. While an SOP form is quite easy for an analyst to use, creating and tracking revisions of the form is not that easy for the person designing the form. An electronic SOP system should provide form designing functionality that streamlines the process of designing SOP forms. Additionally, the electronic system should maintain electronic signatures and revision histories for all SOP s and provide a facility to publish approved SOP forms to the analyst. Electronic document management systems (EDMS) provide some of this functionality for the form author, such as the ability to track the revision changes and housing documents in a centralized location; however, these systems often lack a convenient mechanism for maintaining 21 CFR Part 11 compliant documents during workflow implementation by the QC analyst. Form designing functionality within an electronic SOP system allows the form author to enforce a workflow while following the protocol within the form, as well as providing a convenient means to interface with other electronic systems, such as LIMS, reagent inventories, CDS, ph meters, and electronic balances (a feature absent from EDMS s). The form shown in Figure 5 makes use of a reagent inventory system and an electronic balance. Finally, the form embeds a QC department validated equation into a compliant-ready application shell (21 CFR Part 11, Annex 11) to ensure authentic and traceable data. Prerequisites Step 1 Step 2 Volumetric flask: Flask volume Description: Mobile Phase 100 ml Locale methanol, and benzoic acid from inventory and record identifying information. Component Batch no. Source Expire date Methanol Benzoic acid Description: Prepare a solution of benzoic acid in methanol containing about 6 mg per ml. Add 20 ml of methanol to the volumetric flask then add the benzoic acid. Swirl flask, then add methanol to volume. Component Desired amount Actual amounts Units Benzoic acid 600 mg Concentration 0 mg/ml Figure 5. Third documentation step of a HPLC dissolution study. This form enforces a workflow, automatically interfaces with an external reagent management system, and performs automated calculations by using formulas validated by the QA department. Cycle-time reduction There is little time differential between transcribing information in a paper form versus electronic form; however, the following examples are dramatically faster in an electronic form: n An electronic form reduces the transcription times by interfacing directly with electronic instruments to pull information directly into the forms, while employing error proofing within the forms. n Quality assurance efforts to assess compliance are reduced by 50-70%, since all documents are housed within a compliant-ready solution. n Direct database-to-database interfaces provide rapid access to chemical reagent and instrument fit-for-use information. n Information reuse dramatically reduces the time to convert measurement data collected in printed instrument reports into usable results or answers. One example comes from a Waters customer in the medical device industry. The company conducted an HPLC dissolution study that collected analytical results by using Empower and then electronically captured the raw reports into ugenesis SDMS. An automation script created by Waters Professional Services reused the multi-day content found in the raw reports to produce a report summary that included statistics and graphs. The automated script converted a two week manual process into a 10-minute semiautomated process. 7
8 COCLUSIO Eroding profit margins, more product recalls, and the FDA s focus on quality by design has led the pharmaceutical industry to adopt Lean Six Sigma in manufacturing. While QC testing plays a crucial role in guaranteeing the quality, safety, and efficacy of pharmaceutical products, it also represents a significant portion of the product manufacturing time. Ubiquitous documentation steps to satisfy regulations require significantly more time for QC testing. Electronic SOP systems like SDMS Intelligent Procedure Manager offer the potential to eliminate waste, improve workflows, and improve quality thereby addressing the central tenets of Lean process improvement. References 1. L Abboud, Scott Hensley, ew Prescription for Drug Makers: Update the Plants, The Wall Street Journal, A1, September 3, G K Raju, Pharmaceutical Manufacturing: ew Technology Opportunities, a 2001 presentation to FDA s Science Board, 3. U.S. Food and Drug Administration Enforcement Reports, Santiago, Process Excellence in the Manufacturing Value Chain, 2004, 5. A Shanley, Right the First Time, 2004, 6. A Shanley, ovartis Goes Lean, 2004, Waters and ugenesis are registered trademarks of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Produced in the U.S.A. September en PC-PDF Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:
Thomas Schmidt, Wolfgang Lemmerz, and Chris Stumpf Waters Corporation, Milford, MA U.S. INTRODUCTION. QC data and test result management
Increasing Quality Control Testing Efficiency with Compliant-Ready SOP Digital Forms Thomas Schmidt, Wolfgang Lemmerz, and Chris Stumpf Waters Corporation, Milford, MA U.S. INTRODUCTION Pharmaceutical
More informationCompliance Control Procedure Execution Management System Reduces Compliance Risks by 10X
Compliance Control Procedure Execution Management System Reduces Compliance Risks by 10X By John Helfrich, VelQuest Corporation INTRODUCTION The top drug GMP violations in 2009 involved failings in manufacturers'
More information[NUGENESIS SAMPLE MANAGEMENT ] AMPLE IMPROVING LAB EFFICIENCY, ANAGEMENT ACCELERATING BUSINESS DECISIONS. bigstock.com $69
[NUGENESIS SAMPLE MANAGEMENT ] AMPLE ACCELERATING BUSINESS DECISIONS IMPROVING LAB EFFICIENCY, ANAGEMENT bigstock.com $69 [ N U GENESIS SAMPLE MANAGEMENT ] MANAGING SAMPLES SHOULD NEVER BE A BARRIER TO
More informationPharmaceutical QC Laboratories. 2011 Waters Corporation 1
Lean Six Sigma in Pharmaceutical QC Laboratories Heather Longden 2011 Waters Corporation 1 Topics Lean Six Sigma in the Pharmaceutical Industry Lean Six Sigma in the Analytical l Laboratory Case Study
More informationLaboratory Data Management Systems
Laboratory Data Management Systems Colin Taft, J&L LES project lead Eddie Ryan, Director, Systematic I.S. Strategies October 17 th, Dublin 1 Introductions Eddie Ryan, Systematic I.S. Strategies Ltd BE,
More informationValidating Methods using Waters Empower TM 2 Method. Validation. Manager
Validating Methods using Waters Empower TM 2 Method Validation Manager (MVM) Anders Janesten Nordic Informatics Sales Specialist 2008 Waters Corporation Decision-centric centric method development information
More informationLaboratory Informatics Business Solutions. A collection of customer success stories
Laboratory Informatics Business Solutions A collection of customer success stories [ TABLE OF CONTENTS ] Customer success is the true measure of product performance Waters Laboratory Informatics Software
More informationLaboratory Information Management System
Laboratory Information Management System Lab Inventory Statistical Process Control LIMS Calibration Stability Dispensing Reagents Management Instrument Interfacing ERP Interface Complaint Tracking Process
More informationProcess Manufacturing Solutions Delivered by Tectura
Process Manufacturing Solutions Delivered by Tectura TECTURA MAKES A DISTINCTIVE DIFFERENCE FOR PROCESS MANUFACTURERS Customer demands for fast deliveries and lower costs, together with increasingly stringent
More informationAssuring E Data Integrity and Part 11 Compliance for Empower How to Configure an Empower Enterprise
Assuring E Data Integrity and Part 11 Compliance for Empower How to Configure an Empower Enterprise 2013 Waters Corporation 1 Agenda Electronic Record regulations, Compliance Policy Guides and Warning
More informationOperations Management and the Integrated Manufacturing Facility
March 2010 Page 1 and the Integrated Manufacturing Facility This white paper provides a summary of the business value for investing in software systems to automate manufacturing operations within the scope
More informationFDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry
FDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry The Rule 21 CFR Part 11 Handwritten signature means the scripted name or legal mark of an individual handwritten
More informationAuditing Chromatographic Electronic Data. Jennifer Bravo, M.S. QA Manager Agilux Laboratories
Auditing Chromatographic Electronic Data Jennifer Bravo, M.S. QA Manager Agilux Laboratories Outline Raw data paper or electronic record? Controls for electronic data Auditing electronic records Warning
More informationFive Tips to Achieve a Lean Manufacturing Business
Five Tips to Achieve a Lean Manufacturing Business Executive Overview Introduction The more successful manufacturers today are those with the ability to meet customer delivery schedules while maintaining
More informationStep-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry
Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry BY GHULAM A. SHABIR Introduction Methods Validation: Establishing documented evidence that provides a high
More informationState Water Resources Control Board Environmental Laboratory Accreditation Program
State Water Resources Control Board Environmental Laboratory Accreditation Program P.O. Box 100, Floor 24 850 Marina Bay Parkway, Build. P 500 N Central Ave, Suite 500 Sacramento, CA 95812-0100 Richmond,
More informationMeriCal Quality Profile
January 5, 2015 Dear Valued Customer, Since the implementation of new federal regulations, MeriCal Inc. has received a large volume of questionnaires and surveys regarding our services and procedures.
More informationInternational GMP Requirements for Quality Control Laboratories and Recomendations for Implementation
International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation Ludwig Huber, Ph.D. ludwig_huber@labcompliance.com Overview GMP requirements for Quality Control laboratories
More informationOptimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy
Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy Global Pharma Sourcing Conference December 6-7, 2011 Philadelphia, USA Nigel J. Smart, Ph.D. Smart Consulting
More informationElectronic Raw Data and the Use of Electronic Laboratory Notebooks
7th WRIB- M-2 Workshop Electronic Raw Data and the Use of Electronic Laboratory Notebooks Ron Shoup Outline for Today Raw Data- defining it, creating it, and keeping it for posterity Hybrid Data- paper,
More informationBusiness Process Improvement in Life Sciences Manufacturing through the Integration of Information and Production Management Systems and Automation
Business Process Improvement in Life Sciences Manufacturing through the Integration of Information and Production Management Systems and Automation ANTHONY V SOLLAZO Life Sciences Industry Solutions Manager
More informationProcess Redesign to Exploit the Tangible Benefits of Electronic
CHAPTER 6 Process Redesign to Exploit the Tangible Benefits of Electronic Signatures with acds Although not an apparent part of computer validation, process mapping and analysis is a vital first step in
More informationResults Count LABWARE ELN. LabWare ELN. www.labware.com. LabWare
LABWARE ELN LabWare ELN www.labware.com A feature rich Electronic Laboratory Notebook that is seamlessly integrated with the world s most popular Laboratory Information Management System Project Overview
More informationOperational Business Intelligence in Manufacturing
Operational Business Intelligence in Manufacturing Copyright 2007 KeyTone Technologies Inc. Page 1 SmartWIP - Intelligent Manufacturing with RFID Manufacturers are under competitive pressure to fulfill
More information(One Company s Story) Eric Ellingson
The Evolution of Master Data (One Company s Story) Eric Ellingson Agenda Timeline of our LIMS projects Background of Catalog & Terminology The Old Process The New Process Further Evolution of Our Process
More informationDesigning a CDS Landscape that Ensures You Address the Latest Challenges of the Regulatory Bodies with Ease and Confidence
Designing a CDS Landscape that Ensures You Address the Latest Challenges of the Regulatory Bodies with Ease and Confidence Heather Longden Senior Marketing Manager, Informatics Regulatory Compliance 2015
More informationANALYTICAL METHODS INTERNATIONAL QUALITY SYSTEMS
VALIDATION OF ANALYTICAL METHODS 1 GERT BEUVING INTERNATIONAL PHARMACEUTICAL OPERATIONS TASKS: - Internal auditing - Auditing of suppliers and contract manufacturers - Preparing for and guiding of external
More informationImplementing New USP Chapters for Analytical Method Validation
Implementing New USP Chapters for Analytical Method Validation March 2010 Ludwig Huber Fax.: +49 7243 602 501 E-mail: Ludwig_Huber@labcompliance.com Today s Agenda Handling Method Changes vs. Adjustments
More informationQuality Takes Lead in MOM Software Deployments and Performance Benefits
Quality Takes Lead in MOM Software Deployments and Performance Benefits 1 Quality Takes Lead in MOM Software Deployments and Performance Benefits See the scope of MOM-focused Quality Management software
More informationQAD ENTERPRISE APPLICATIONS
IS BUILT FOR MANUFACTURERS, BUILT FOR YOU Effective manufacturers depend on their enterprise resource planning (ERP) solution to streamline business operations and to scale and adapt as their business
More informationHow a LIMS Can Save Your Laboratory Money and Enhance Data Quality
How a LIMS Can Save Your Laboratory Money and Enhance Data Quality Steve Rayburn, Director of Training and Validation and Dr. Christine Paszko, Vice President of Sales and Marketing Accelerated Technology
More information21 CFR Part 11 Compliance Using STATISTICA
21 CFR Part 11 Compliance Using STATISTICA Last Updated: April 2003 This document was updated to reflect the FDA s latest guidance (released February, 2003) and the withdrawal of previous guidance.! STATSOFT
More informationComputerised Systems in Analytical Laboratories
ECA Certified Computer Validation Manager Course* New EU Annex 11 and Chapter 4 Requirements will be covered Computerised Systems in Analytical Laboratories Foto: DRK The Electronic Analytical GMP : Integrating
More informationWork Process Management
GE Intelligent Platforms Work Process Management Achieving Operational Excellence through Consistent and Repeatable Plant Operations With Work Process Management, organizations can drive the right actions
More informationProduct Lifecycle Management in the Medical Device Industry. An Oracle White Paper Updated January 2008
Product Lifecycle Management in the Medical Device Industry An Oracle White Paper Updated January 2008 Product Lifecycle Management in the Medical Device Industry PLM technology ensures FDA compliance
More informationMoving from Paper to Electronic Records: Hardwiring Compliance into Product Development Using technology to incorporate quality system regulation
P T C. c o m White Paper Medical Devices Page 1 of 8 Moving from Paper to Electronic Records: Hardwiring Compliance into Product Development Using technology to incorporate quality system regulation Abstract
More informationImpact of Formula-Based ERP Applications on Pharmaceutical Manufacturers
Impact of Formula-Based ERP Applications on Pharmaceutical Manufacturers Executive Summary Whether you re in the process of re-evaluating your existing ERP application or looking to replace your spreadsheets,
More informationAPPENDIX N. Data Validation Using Data Descriptors
APPENDIX N Data Validation Using Data Descriptors Data validation is often defined by six data descriptors: 1) reports to decision maker 2) documentation 3) data sources 4) analytical method and detection
More informationCarolina s Solution Preparation Manual
84-1201 Carolina s Solution Preparation Manual Instructions Carolina Biological Supply Company has created this reference manual to enable you to prepare solutions. Although many types of solutions may
More informationTools to Aid in 21 CFR Part 11 Compliance with EZChrom Elite Chromatography Data System. White Paper. By Frank Tontala
Tools to Aid in 21 CFR Part 11 Compliance with EZChrom Elite Chromatography Data System White Paper By Frank Tontala Agilent Technologies Software & Informatics Life Sciences & Chemical Analysis Group
More informationORACLE PROCESS MANUFACTURING QUALITY MANAGEMENT
ORACLE PROCESS MANUFACTURING QUALITY MANAGEMENT KEY FEATURES Automated stability study management Lot expiration handling and retesting Potency or variability management Quality holds during receiving
More informationBuilding the Business Case for BPM Automation in Process Manufacturing
Building the Business Case for BPM Automation in Process Manufacturing Business process management automation streamlines your enterprise, strengthens your ERP solution and dramatically lowers costs. If
More informationThe BlazeLIMS Family of Products Functional Specs V5.5
The BlazeLIMS Family of Products Functional Specs V5.5 These Functional Specs have been organized according to the workflow of a comprehensive laboratory that uses all the LIMS functions. Depending on
More informationIncreasing Lab Efficiency by Automating Sample Test Workflows Using OpenLAB Enterprise Content Manager (ECM) and Business Process Manager (BPM)
Increasing Lab Efficiency by Automating Sample Test Workflows Using OpenLAB Enterprise Content Manager (ECM) and Business Process Manager (BPM) Technical te Solution Benefits Streamlines sample-test workflows
More informationFACTORYTALK PRODUCTIONCENTRE Application Solutions for Manufacturing
FACTORYTALK PRODUCTIONCENTRE Application Solutions for Manufacturing F a c t o r y T a l k P r o d u c t i o n C e n t r e FACTORYTALK A COMPLETE PRODUCTION MANAGEMENT SOLUTION Bring measured improvements
More informationWaters Empower 2 Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance
THE ROLE OF WATERS EMPOWER 2 SOFTWARE IN ASSISTING IN 21 CFR PART 11 COMPLIANCE Waters Empower 2 Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance Summary The objective of
More informationTHE ROLE OF WATERS NUGENESIS SDMS IN 21 CFR PART 11 COMPLIANCE
THE ROLE OF WATERS NUGENESIS SDMS IN 21 CFR PART 11 COMPLIANCE The objective of this article is to discuss the 21 CFR Part 11 compliance utility of the Waters NuGenesis Scientific Data Management System
More informationWelcome Computer System Validation Training Delivered to FDA. ISPE Boston Area Chapter February 20, 2014
Welcome Computer System Validation Training Delivered to FDA ISPE Boston Area Chapter February 20, 2014 1 Background Training Conducted on April 24, 2012 Food & Drug Administration Division of Manufacturing
More informationAligning Quality Management Processes to Compliance Goals
Aligning Quality Management Processes to Compliance Goals MetricStream.com Smart Consulting Group Joint Webinar February 23 rd 2012 Nigel J. Smart, Ph.D. Smart Consulting Group 20 E. Market Street West
More informationSupply Chain Management Build Connections
Build Connections Enabling a business in manufacturing Building High-Value Connections with Partners and Suppliers Build Connections Is your supply chain responsive, adaptive, agile, and efficient? How
More informationDO MORE AND DO IT WITH CONFIDENCE. Empower 3 Chromatography Data Software
Empower 3 Chromatography Data Software DO MORE AND DO IT WITH CONFIDENCE MORE THAN 350,000 USERS CAN T BE WRONG 2 EXPECT MORE FROM YOUR CDS AND GET IT Waters Empower 3 software is the most widely used
More informationSimultaneous determination of L-ascorbic acid and D-iso-ascorbic acid (erythorbic acid) in wine by HPLC and UV-detection (Resolution Oeno 11/2008)
Method OIV-MA-AS313-22 Type II method Simultaneous determination of L-ascorbic acid and D-iso-ascorbic acid (erythorbic acid) in wine by HPLC and UV-detection (Resolution Oeno 11/2008) 1. Introduction
More informationBika Open Source LIMS. Top level functional specification Inventory and Supply Chain Management
Bika Open Source LIMS. Top level functional specification Inventory and Supply Chain Management This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
More informationB i o s o l u t i o n s
B i o s o l u t i o n s Implementation of pharmatracker TM : A case study Prepared by Ocimum Biosolutions Ocimumbio Solutions August 2006 All rights reserved. 2 B i o s o l u t i o n s an ISO 9001:2000
More informationConducting a Gap Analysis on your Change Control System. Presented By Miguel Montalvo, President, Expert Validation Consulting, Inc.
Conducting a Gap Analysis on your Change Control System Presented By Miguel Montalvo, President, Expert Validation Consulting, Inc. Standards, Regulations, Guidelines related to Change Control Management
More informationIBM Enterprise Content Management: Streamlining operations for environmental compliance
Solution Brief IBM Enterprise Content Management: Streamlining operations for environmental compliance Highlights Helps improve operational efficiency and lower costs Provides capabilities that enable
More informationTotalChrom. Chromatography Data Systems. Streamlining your laboratory workflow
TotalChrom Chromatography Data Systems Streamlining your laboratory workflow maximize productivity with TotalChrom CDS Acquiring, processing, reporting, reviewing and approving data is a streamlined series
More information4 Elements of an Effective Food Safety Management System. How to meet your changing challenges and ensure success.
4 Elements of an Effective Food Safety Management System How to meet your changing challenges and ensure success. Safety is everything Food and Beverage manufacturers face a range of pressures: increasingly
More informationWaters Empower Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance
THE ROLE OF WATERS EMPOWER SOFTWARE IN ASSISTING IN 21 CFR PART 11 COMPLIANCE Waters Empower Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance Summary The objective of this
More informationWonderware MES 4.0/Operations and Performance Software
Software Datasheet Summary Wonderware MES 4.0 gives manufacturers a full- Wonderware MES 4.0/Operations and Performance Software featured Manufacturing Execution System (MES) to effectively manage your
More informationManual 074 Electronic Records and Electronic Signatures 1. Purpose
1. Purpose The purpose of this document is to provide an interpretation of FDA 21 CFR Part 11, Electronic Records; Electronic Signatures (ER/ES) and to provide guidance for acceptable practices in the
More informationThe Four Elements of an Effective Food Safety Management System
The Four Elements of an Effective Food Safety Management System Plex Online White Paper At a Glance As processors develop and enhance their Food Safety Management Systems (FSMSs), four key components enable
More information11.I In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07
In-process control In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07 Here you will find answers to the following questions: What are the in-process control tasks? Where
More informationRobert Birdsall, Eoin Cosgrave, Henry Shion, and Weibin Chen Waters Corporation, Milford, MA, USA APPLICATION BENEFITS INTRODUCTION WATERS SOLUTIONS
Automating the Determination of Drug-to-Antibody Ratio (DAR) of Antibody Drug Conjugates (ADCs) Based on Separation by Hydrophobic Interaction Chromatography (HIC) Robert Birdsall, Eoin Cosgrave, Henry
More informationResource Scheduling in QC Laboratories
Reprinted from PHARMACEUTICAL ENGINEERING The Official Technical Magazine of ISPE November/December 2012, Vol 32, No 6 Copyright ISPE 2012 www.pharmaceuticalengineering.org quality systems in QC Laboratories
More informationFull Compliance Contents
Full Compliance for and EU Annex 11 With the regulation support of Contents 1. Introduction 2 2. The regulations 2 3. FDA 3 Subpart B Electronic records 3 Subpart C Electronic Signatures 9 4. EU GMP Annex
More informationSelecting SPC Software for Batch and Specialty Chemicals Processing
WHITE PAPER Selecting SPC Software for Batch and Specialty Chemicals Processing Statistical Process Control (SPC) is a necessary part of modern chemical processing. The software chosen to collect quality
More informationSINGLE ERP SOFTWARE VS. MULTIPLE SOFTWARE SYSTEMS. Advantages of Using One Enterprise Solution for Your Process Manufacturing Business
Advantages of Using One Enterprise Solution for Your Process Manufacturing Business Advantages of Using One Enterprise Solution for Your Process Manufacturing Business INTRODUCTION Enterprise Resource
More informationThe Definitive Guide to Data Blending. White Paper
The Definitive Guide to Data Blending White Paper Leveraging Alteryx Analytics for data blending you can: Gather and blend data from virtually any data source including local, third-party, and cloud/ social
More informationOPERATIONALIZING EXCELLENCE IN THE GLOBAL REGULATORY SUBMISSIONS PROCESS
OPERATIONALIZING EXCELLENCE IN THE GLOBAL REGULATORY SUBMISSIONS PROCESS INTRODUCTION As life sciences companies face expiring patents and shrinking drug-development pipelines, it s never been more important
More informationTapping the benefits of business analytics and optimization
IBM Sales and Distribution Chemicals and Petroleum White Paper Tapping the benefits of business analytics and optimization A rich source of intelligence for the chemicals and petroleum industries 2 Tapping
More informationOPERATIONAL STANDARD
1 of 11 1. Introduction The International Safe Transit Association (ISTA), a non-profit association whose objective is to prevent product damage and excess packaging usage within the distribution environment.
More informationUnderstanding Manufacturing Execution Systems (MES)
Understanding Manufacturing Execution Systems (MES) Presented by: Shirley Schmidt Freedom Technologies 10370 Citation Dr., Suite 200 Brighton, MI 48116 Phone: 810-227-3737 www.freedomcorp.com What is a
More informationA Generic Kit-Based Approach for Quantifying Monoclonal Antibody Drugs Through Direct Digestion of Discovery Study Samples
A Generic Kit-Based Approach for Quantifying Monoclonal Antibody Drugs Through Direct Digestion of Discovery Study Samples Mary Lame, Hua Yang, Sherri Naughton, and Erin Chambers Waters Corporation, Milford,
More informationANALYTICAL OUTSOURCING WHY SHOULD YOU OUTSOURCE?
ANALYTICAL OUTSOURCING WHY SHOULD YOU OUTSOURCE? The choice to outsource is a somewhat difficult decision, but it is one that can be both analytically and financially rewarding. By carefully considering
More informationFocused on your goals SERVICES AND SUPPORT CAPABILITIES OVERVIEW
Focused on your goals SERVICES AND SUPPORT CAPABILITIES OVERVIEW Laboratories today face complex scientific and business challenges that require the support of a true service partner a service partner
More informationBuilding the Business Case for Automated Rapid Testing: Translating the benefits of rapid automated microbial testing into dollars saved
Building the Business Case for Automated Rapid Testing: Translating the benefits of rapid automated microbial testing into dollars saved A whitepaper by: Opportunities in Micro Quality Control According
More informationPharmaceutical Quality Systems: US Perspective
Pharmaceutical Quality Systems: US Perspective Rick Friedman Associate Director, Office of Manufacturing and Product Quality Center for Drug Evaluation and Research Topics Background: The ICH Q10 Pharmaceutical
More informationSage ERP X3 I White Paper
I White Paper Managing Government Regulations with ERP: Key features to look for when selecting your new system By Tom Heinricher, Senior Business Consultant, Introduction More and more, companies are
More informationSage 300 ERP 2014 Get more done.
Sage 300 ERP 2014 Get more done. Get more done by connecting your business, providing a better customer experience, and increasing revenue. New web and mobile functionality: driving better customer experiences
More informationA ChemoMetec A/S White Paper September 2013
NucleoCounter NC-3000, NucleoView NC-3000 Software and Code of Federal Regulation 21 Part 11; Electronic Records, Electronic Signatures (21 CFR Part 11) A ChemoMetec A/S White Paper September 2013 ChemoMetec
More informationUsing Natural Products Application Solution with UNIFI for the Identification of Chemical Ingredients of Green Tea Extract
Using Natural Products Application Solution with UNIFI for the Identification of Chemical Ingredients of Green Tea Extract Lirui Qiao, 1 Rob Lewis, 2 Alex Hooper, 2 James Morphet, 2 Xiaojie Tan, 1 Kate
More informationHow To Schedule A Lab
Online Exclusive from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE September/October 2012, Vol. 32 No. 5 www.pharmaceuticalengineering.org Copyright ISPE 2012 This article presents the various
More information1. Scope This SOP covers requirements for PHARMCO-AAPER s Quality Management System
Page 1 of 8 1. Scope This SOP covers requirements for PHARMCO-AAPER s Quality Management System 2. Application This Standard Operating Procedure applied to the entire Quality Management System as it relevant
More informationMHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This
More informationRoss Systems Inventory Control Module
Ross Systems Inventory Control Module The information found on the following pages is intended to present functional details associated with Ross Systems Inventory Control Module. For questions or details
More information1 Quality Assurance and Quality Control Project Plan
1 Quality Assurance and Quality Control Project Plan The purpose of this section is to describe the quality assurance/quality control program that will be used during the system specific field testing
More informationStreamlining the drug development lifecycle with Adobe LiveCycle enterprise solutions
White paper Streamlining the drug development lifecycle with Adobe LiveCycle enterprise solutions Using intelligent PDF documents to optimize collaboration, data integrity, authentication, and reuse Table
More informationGoing Mobile Drives Paperless
Going Mobile Drives Paperless 01. Going Mobile Going mobile is the key differentiator in driving paperless asset management (whether you are using an EAM, CMMS or CCMS). This is mostly because the use
More informationEffective Asset Management for Life Sciences
Effective Asset Management for Life Sciences The business value Life sciences companies face stiff challenges to their long-term profitability in the form of mounting regulatory pressures, increasing price
More informationMultivariate Chemometric and Statistic Software Role in Process Analytical Technology
Multivariate Chemometric and Statistic Software Role in Process Analytical Technology Camo Software Inc For IFPAC 2007 By Dongsheng Bu and Andrew Chu PAT Definition A system Understand the Process Design
More informationThe FDA recently announced a significant
This article illustrates the risk analysis guidance discussed in GAMP 4. 5 By applying GAMP s risk analysis method to three generic classes of software systems, this article acts as both an introduction
More informationVisibility and Integration - The Key Ingredients for a Successful Supply Chain
Visibility and Integration - The Key Ingredients for a Successful Supply Chain An Industry White Paper By Laura Rokohl, Supply Chain Marketing Manager, AspenTech About AspenTech AspenTech is a leading
More informationSoftware Development for Medical Devices
Software Development for Medical Devices Overcoming the Challenges of Compliance, Quality and Cost Software is fast becoming the differentiator for manufacturers of medical devices. The rewards of software
More informationBiorepository and Biobanking
Biorepository and Biobanking LabWare s solution for biorepositories and biobanks combines powerful specimen tracking and logistics capabilities with specimen processing and workflow management features.
More informationVALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1)
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY
More informationSALES AND OPERATIONS PLANNING BLUEPRINT BUSINESS VALUE GUIDE
Business Value Guide SALES AND OPERATIONS PLANNING BLUEPRINT BUSINESS VALUE GUIDE INTRODUCTION What if it were possible to tightly link sales, marketing, supply chain, manufacturing and finance, so that
More informationComputerised Systems. Seeing the Wood from the Trees
Computerised Systems Seeing the Wood from the Trees Scope WHAT IS A COMPUTERISED SYSTEM? WHY DO WE NEED VALIDATED SYSTEMS? WHAT NEEDS VALIDATING? HOW DO WE PERFORM CSV? WHO DOES WHAT? IT S VALIDATED -
More informationWinKQCL 5 Endotoxin Detection and Analysis Software We Analyze Endotoxin Data Every Day
Pharma&Biotech WinKQCL 5 Endotoxin Detection and Analysis Software We Analyze Endotoxin Data Every Day For Endotoxin Detection Pharma&Biotech WinKQCL 5 Software for Endotoxin Detection and Analysis WinKQCL
More informationEnd to end Clinical Trial Supply Management with SAP
End to end Clinical Trial Supply Management with SAP by Infosys Lodestone CTSM is a leading factor in conducting clinical studies. Table of Contents A Leading Factor in conducting Clinical Studies is the
More information