The Paperless QMS March 2012

Transcription

1 The Paperless QMS March 2012

2 Overview Introductions What do we mean by Paperless QMS? Short history of the (pharma) Paperless QMS What do you need your Paperless QMS to do? Practical application and considerations Advantages and Disadvantages Practical applications - examples Close out and Questions GxPi

3 GxPi Overview We simplify complex process and technology environments to deliver our customers compliance and quality goals in their regulatory framework. We achieve this through a combination of Services and Products that transfer our expertise to our customers. GxPi

4 QMS - definition The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. Source: GAMP Good Practice Guide IT Infrastructure Control and Compliance GxPi

5 QMS - definition A Quality Management System (QMS) provides a management framework that gives you the necessary controls to address risks and monitor and measure performance in your business. It can also help you to enhance your image and reputation and enable you to look for improvements through internal and external communications. Source: BSI GxPi

6 QMS framework models Facilities & Equipment Facilities & Equipment Manufacturing Quality Control Manufacturing Quality Control Management Management Quality Material Quality Material Packaging & Labeling Packaging & Labeling e.g. QC services company or contracted-out manufacturing services e.g. GMP Manufacturer with contracted-out packaging GxPi

7 QMS content an example Change Control Investigations/CAPA Training Document Control Specifications Quality Agreements Batch records Stability Product Complaints Recall Annual Product Review Supplier Audits Regulatory framework (GMP example) GxPi

8 QMS - content The core element is the framework The content created is a by-product which is worth having and valued because of the framework within which it was produced The volume of transactions and the increasingly virtual nature of organisations: Increasingly electronic content Electronic approvals & workflows Overarching document and process control Paperless QMS = LESS paper!!! GxPi

9 Paperless QMS - history Largely mirrors the development of systems overall Early days: Highly custom systems Number of separate (disparate even) systems to meet overall need High Total Cost of Ownership Inflexible systems, difficult to change, upgrade Complex to validate GxPi

10 Paperless QMS - history Maturity of the market in terms of products leads towards: Creation of standard product platforms Greater integration between components Increased Configurability Decreased validation effort due to reduced customisation Lower TCO particularly around change, upgrade GxPi

11 Paperless QMS - Principle Elements Content management components: Core Quality Documents SOPs Policies, Guides, WI etc. Methods, Specifications, Master Batch records Records e.g. Executed batch records, CoA etc. Validation Documents All the other documents produced under the QMS framework GxPi

12 Paperless QMS - Principle Elements Process Management components: Document management Templates and Forms Change Control CAPA Out of Specification (OOS) & Deviation management Complaints Training Management & resulting Records Audit GxPi

13 Understanding your QMS Its mostly a Process issue and the Content is the smaller end of the deal or Its mostly a Content issue and the Process is the smaller end of the deal GxPi

14 Understanding your QMS Perhaps it should be more like this... More of a balanced situation but the volume of content is growing very, very quickly Process Engine Content Mgt. GxPi

15 What do you need your QMS to do? Like all Quality related decisions the goal is to create an environment that is fit for purpose and right for your business not purely driven by the letter of the regulations Needs investment in specification definition from all stakeholders, not imposed by a Quality Department It is not just an IT or Quality decision An electronic QMS offers access to a high degree of functionality... BUT - is it all needed? Pick and choose the modules that add value Don t kill the business with the burden/overhead GxPi

16 Major characteristics of the system Global reach real or virtual Data driven, document supported Capable of managing complex issues Overarching reporting features: Progress to date Performance indicators GxPi

17 Major characteristics of the system Capable of change, without fundamental rebuilding Modular Building block based Tool kit components Capable of absorbing content from external sources Management of training and competence demonstration in the QMS Support the Audit in the system or outside? Need for flexible viewing tools to make audit sustainable GxPi

18 Benefits of multi-track issue management Typical linear simple single track approach CAPA Request Corrective Action Root Cause Analysis Preventative Action CAPA Approval CAPA Authorisation Implement Preventative Action Close Data driven electronic multi stream approach Overall Process DashBoard and reporting Audit Finding CAPA Issue Initiation Corrective Action Root Cause Analysis Preventative Action CAPA Approvals Implement Actions Sub Issue Closure Close Preventative Action CAPA Approvals Implement Actions CAPA Request Corrective Action Root Cause Analysis Preventative Action CAPA Approvals Implement Actions Sub Issue Closure Root Cause Analysis Preventative Action CAPA Approvals Implement Actions Alternate Entry Points Corrective Action Root Cause Analysis Preventative Action CAPA Approvals Implement Actions Sub Issue Closure GxPi

19 Automation is not an end in itself Two important things to bear in mind Automating poor manual systems will not make them good Lack of compliance in an electronic paperless system will be clearer, more starkly visible that ever it was in paper the audit trail is unwavering It needs to be a balance between the components All need to be Effective Contributing Balanced GxPi

20 System selection problems and pitfalls Have you got a QMS or is that part of the project? Is the goal to automate the current system? Or replace it with a complete solution? Key going into the project is clarity of Scope Objectives Requirements Commitment across the business Timeline & drivers GxPi

21 System selection problems and pitfalls Other factors to consider: Cost! Level of resource to maintain Migration of current content Organisational Change management - adoption by all Validation and compliance Ownership GxPi

22 Paperless QMS Practical applications Big Pharma Part of standard business system portfolio Management tool KPIs Small Pharma / Biotech Lower cost of ownership from standard products Streamline the system Ease the burden to deliver the quality outcomes Suited to outsourced / virtualised companies Service Provider (such as contract QC lab) Management of vendor audit Evidence of competence to deliver service Access to information about the contract / service GxPi

23 Paperless QMS Conclusions Fitness for purpose Understand what it is you need your QMS to do for your business (Process and Content) Preparation, preparation, preparation Just because functionality is available within an electronic QMS it may not be of value to you Understand the investment in specification, implementation, validation and use A poor paper-based system will remain a poor QMS if change is not implemented GxPi

24 Products and Services that are Simply Compliant GxPi