Quality Management System

Document IT supports Quality Management System (QMS) with a good Knowledge Sharing & Training environment.

Validation Services

Document IT provides specific services like Cleaning Validation, Process validation, Analytical method validation, Equipment & Computer System Validation (CSV, GAMP).

Enterprise Quality Management Services

Quality change management, CAPA management, introducing & running a risk based validation &/or quality approach & many more services.

GxP Quality Management - Overview of Services

Laboratory GLPs, Clinical GCPs, Manufacturing GMPs,​ Documentation GDPs​, General GxPs & ICH Quality Management Services.​

Quality Assurance - Overview of Services

Document IT provides services like GLP, GCP, cGMP

Package & Vendor Selection

Document IT assists clients to quickly identify, select & acquire software applications & technologies from specialist vendors.

Risk Management

Document IT provide clients with the capability to identify and manage business and regulatory risks including operational, regulatory and product risk.

Quality Resources

We will review your existing Quality Manual and Procedures for conformance to the regulations and standards you require, or help you to create a QMS to meet your requirements.

Quality Management

For more than 15 years Document IT and its partners have been at the forefront of computerized system validation and IT system compliance. In particular with its partner Compliance Control, who has been instrumental in helping the Life Sciences industry respond to regulatory initiatives since the late 1980’s, we cover todays wide range of services designed for the CSV area; these are:

  • Best Practices for the validation of GxP significant computer systems
  • Electronic records and signatures, including 21 CFR Part 11 and EudraLex Annex 11
  • IT infrastructure qualification and control
  • Risk-based validation of computer systems

Document IT has since 1999 actively contributed to the development of regulatory guidance and industry best practice. The strategic partnership with Compliance Control since 2013 gives customers access to a large pool of CSV services and experienced individuals paired with industry specific knowledge in any of the GxPs.

Quality Management System

Our regulatory landscape as well as our business requirements change constantly. New regulations are published, changing industry standards, guidelines and good practices are updated. Same time the requirements of any business are changing over time, as does the organisational structure required to support that business.

To facilitate such scenario the GAMP® Guide recommends that Life Sciences organisations run a formalised IT Quality Management System (QMS). For Document IT a QMS should be supported with a good Knowledge Sharing and Training environment.

While most departments in IT or business do have some or most of the required policies and procedures in place, these may not be formalised in a single QMS, may not be lived by the associates or may not be up to date in regards to efficiency and effectiveness.

Reality shows that even the best IT QMS becomes out-of-date, leading to inefficiencies in IT process or to regulatory observations when organisations fail to follow their own procedures or have not established appropriate processes.

Document IT
Document IT

Validation Services

In the pharmaceutical, medical device, and other similar industries such as food, blood, tissue and clinical trials, validation is the documented act of demonstrating that a procedure, process, and activity will consistently meet the expected results. It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practice and other regulatory requirements.

Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections for which Document IT provides specific services:

  • Cleaning Validation
  • Process validation
  • Analytical method validation
  • Equipment
  • Computer System Validation (CSV, GAMP)

Enterprise Quality Management Services

  • Quality Change Management
  • CAPA Management
  • Introducing and running a Risk Based Validation and/or Quality Approach
  • Business Process Definitions and Execution Control
  • CSV Services - IT Computerized System Validation
  • Cloud and Hybrid Cloud validation
  • Agile Validation Services
  • Automated Testing
  • Training and Knowledge Management

Document IT

GxP Quality Management - Overview of Services

Laboratory GLPs Clinical GCPs​ Manufacturing GMPs Documentation GDPs General GxPs & ICH Quality Management Services
Laboratory Information Systems

Lab Quality Management Systems

Electronic Lab Notebook (eLN)

Paperless Laboratory

Analytical Validation

Device Qualification Services
Site / Investigators Inspection Services

Sponsor Audit Readiness and Audit Preparation

Statistical & Analytical Validation Services

Validation of Statistical Principles for Clinical Trials (ICH E9)

Validation Services for Clinical Data Programming, Clinical Data Warehouse, Clinical Data Management

Validation Services for Trial Master File Management (TMF) / electronic TMF Systems

Validation Services for Common Technical Document - CTD Systems (ICH M4)

Patient Safety and Serious Adverse Event System Validation Support

Device Qualification Services
Validation Support for Asset and Inventory Systems / Asset Change Control Systems

MES - Manufacturing Execution System Validation and Consulting Services

Quality Management in a Paperless Manufacturing / eMaster Batch Records environment

Validation Support for Real-Time Batch Release

Quality and Compliance Support for Drug Supply Chain Management / Drug Supply Management Systems

Infrastructure Qualification Services
Records Management Consulting

Document Archival Validation and System Support

Identify Record Retention Times

Document and Records Lifecycle Reviews

Template / Form Creation and Review Services
GxP Computer System Validation (CSV)

Audit Readiness

Supplier Management

CAPA Management

ICH Q2 Analytical Validation Services

ICH Q7 Good Manufacturing Practices

ICG Q8 Pharmaceutical Development

ICH Q9 Quality Risk Management

ICH Q10 Pharma Quality System

ICH Q11 Lifecycle Management

Quality Assurance - Overview of Services

GLP GCP cGMP
Laboratory Regulatory Compliance and Quality Assurance Clinical Regulatory Compliance and Quality Assurance Current Good Manufacturing Practices Regulatory Compliance and Quality Assurance
Document IT

Package & Vendor Selection

As independent consultants, Document IT has partnerships with all major software vendors. Industry specific knowledge also means that Document IT assists clients to quickly identify, select and acquire software applications and technologies which meet the specific business needs of life sciences companies from specialist vendors.

Risk Management

With mature and cost effective risk management processes and a thorough understanding of key business processes, Document IT provide clients with the capability to identify and manage business and regulatory risks including operational, regulatory and product risk.

Document IT
Document IT

Quality Resources

Our experienced Quality consultants can help ensure that your Quality Management System is helping your business and not hindering it. We will review your existing Quality Manual and Procedures for conformance to the regulations and standards you require, or help you to create a Quality Management System to meet your requirements. In particular using Compliance Control Centre can help to automate your processes including:

  • Documentation
  • Change Control
  • CAPA/Deviations
  • Customer Compliants
  • Auditing
  • Training Records

Project
Management

Our experienced Project Managers can plan, organize, motivate and control your resources to achieve your specific goal(s).

Quality
Management

For more than 15 years Document IT & its partners have been at the forefront of computerized system validation & IT system compliance.

Quality Management

Business
Consulting

Our consultants work with clients to model & improve business processes, streamline operations & assure compliance.

Business Consulting

Resourcing
Services

Our resourcing services are open to any industry looking for a highly skilled worker.

Outsourcing

We currently offer full business process outsourcing within our CDISC Factory for clinical business processes around the usage of standardized clinical data.

Outsourcing

Bio Statistics

Our expertise includes the design & conduct of clinical experiments, the method & way in which data is collected, analysis of data & interpretation of results.

Clinical
Programming

We offer you comprehensive range of high-quality & cost-effective clinical programming services.

Clinical Programming

Clinical Data
Management

We provide end to end clinical data management solutions from data management plan to database lock.

Clinical Data Management

CDISC
Factory

Document IT’s CDISC factory supports & accelerates the set-up of CDISC compliant systems & conversions of legacy clinical trial data to the CDISC standards.

Records
Management

Document IT maintains the records & documents throughout their life cycle from the time they are created until their disposal.

Records Management
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