- Easy management and retrieval of policies and procedures is assured
- Mapping the compliance requirements to application functions
- Policy management workflows are automated and streamlined
- Extensive exceptions handling and issue tracking
- 360° Audit trail
- Data security and role-based access and user capabilities
- One-click document merge for creating Quality Manuals or Submission Files.
- Status of quality management can be viewed in real-time through powerful executive dashboards with drill-down capabilities
- Transform all files to the same format with DocShifter.
- Create FDA-, ICH- and ISO-compliant quality documents.
- You are faced with policy and procedure (SOP) documents or other types of documents that need to comply with regulatory requirements.
- You have difficulties managing, storing and easily retrieving the right information at the right time.
- You are still managing these documents manually or paper-based?
- You are possibly facing security issues.
- You are not sure whether users are always using the correct version of a document
- You are facing additional compliance requirements that will make it even harder managing these documents.
Our Solution:Quality Manager
Automate the process of managing controlled documents with Docbyte’s Quality Manager. Your people take care of the content, while Quality Manager takes care of the workflows, revision cycles, document security, rendition- and version management. Quality Manager supports your compliance officer and takes the repetitive headaches away.
TYPICAL USE CASES
- Submission Management (Life Sciences)
- Standard Operating Procedures
- Laboratory Procedures
- Nursing Procedures
- Test Procedures
- ISO 9001 Quality Documents
- (Material) Safety Data Sheets – Technical Data Sheets
Please contact us to help you with your digital journey
Docbyte has been nominated for the Deloitte Technology Fast 50!
Docbyte has been nominated for Deloitte’s 2016 Technology Fast 50 competition for technology companies headquartered in Belgium. The Fast 50 award will be given to the country’s fastest-growing technology company, based on its percentage of growth in turnover during the last four years.
Does the General Data Protection Regulation apply to paper data?
In short, the GPDR (EU 2016/679) is a regulation by which the European Commission, the European Parliament and the European Council aim to strengthen and unify data protection for individuals within the European Union. It also addresses the export of personal data outside the EU. The regulation was approved on 27 April 2016 and will be effective as from 25 May 2018. It is applicable to all data, in any form, that can be used to identify a person. This means it also applies to paper data.
Why companies must embrace digital transformation right now
The digital revolution is unstoppable. For companies, it gives rise to new challenges and opportunities. To respond to the increasingly demanding expectations of customers, partners and employees, companies should embrace digital transformation.