versiondog - Data management for the pharmaceutical and chemical industries

 

Pharmaceutical manufacturers are legally obliged to comply with a range of regulations and standards, such as FDA and GxP. This requires full and detailed documentation of the entire production process and of regularly conducted self-inspections. Each manufacturing step, every organisational measure and all process conditions must be documented end-to-end to provide full records and complete traceability. versiondog helps companies adhere to FDA and GxP rules with regard to process quality, production documentation and proof of compliance.
 

 

Why do so many companies in your industries use versiondog?

End-to-end documentation of all manufacturing processes

Safeguarded product recipes

Smooth workflow when using the two-person rule

Support for audit trail documentation and reports

Tailored to FDA and GxP requirements

versiondog for the pharmaceutical and chemical industries

versiondog key features

Practical benefits

Audit trail – complete documentation of control program changes
  • Save time due to standardised documentation
  • Simplify complex auditing tasks
  • Replace paper-based documentation systems
  • Generate audit trails at the click of a button
  • Ease adherence to standards, including FDA 21 CRF 11 and GxP
Change management with easy application of the two-person rule
  • Ensure that the two-person rule is followed
  • Ease adherence to other QM rules
  • Keep an unbroken change history of all manufacturing processes
  • Reduce personal liability
  • Avoid serious consequences caused by simple, easily-made errors
Version management – detection of changes to released control programs
  • Ensure clarity and certainty in production
  • Detect unauthorised changes
Archive manager for long-term archiving of data
  • Automatic documentation of all project data for Product
    Lifecycle Management (PLM)
Fast and dependable disaster recovery strategy
  • Save time thanks to automatic backups
  • Reduce downtime and wastage
Centrally-controlled automatic process control system backup (PCS7)
  • Reduce costs by clearly organising and safeguarding data
  • Replace laborious and unreliable manual systems with automatic change documentation

 

Customers from the pharmaceutical and chemical industries use versiondog to:

  • Centralise the change management of project data

  • Backup device data automatically

  • Automate documentation and always know WHO changed WHAT, WHERE, WHEN, and WHY

  • Ease coordination when operating multiple shifts

  • Quickly modify production processes for product variations

  • Ensure consistent quality

  • Save time and money in all production facilities
 

Invest 30 minutes to find out how versiondog can significantly increase safety, certainty and security in your production facility. Book your demonstration now.

 

Worthwhile further reading for companies in your industry

Validation in regulated sectors 

The US Food and Drug Administration (FDA) imposes strict requirements on owners and operators of production facilities in regulated sectors. Manufacturers in these sectors, such as pharmaceutical companies, for example, are only permitted to produce goods in authorised facilities that are Good Manufacturing Practices (GMP) compliant. The same applies to software systems installed on devices used in such production facilities.  

You can find out more about the validation process of software systems being used in regulated sectors and discover how a software provider can help support pharmaceutical companies during this validation process, in our technical article: "Validation in regulated sectors". 

Audits in industrial automation

This free white paper explains the best way to approach such an audit, what exactly is involved, and what are some of the potential pitfalls?

How does a data management system help to answer the typical questions arising from process documentation (who, what, where, when and why), and how does this provide a reliable foundation for audit trails?

This white paper gives you the right answers.

versiondog product overview

Find out more about documentation, version control and automatic backups with versiondog in automated systems and production.

more about versiondog

Device and editor support

Get an overview of versiondog support for automation devices and development environments.

Device support

Individual online presentation

Invest 30 minutes to find out how versiondog can significantly increase safety, certainty and security in your production facility.

Book your demonstration now