QMS for Formpipe to Enter Healthcare Market

One of the Formpipe products is a powerful and highly adaptable Enterprise Content Management (ECM) platform used in many business areas to improve efficiency and ensure quality assurance of information management. Aiming to enter the healthcare market, the client engaged Sigma Software quality managers to bring its Quality Management System (QMS) into compliance with Healthcare industry standards.

 

SOLUTION

The joint team of the client and Sigma Software quality managers have reviewed, evaluated and documented existing processes, introduced the missing procedures and instructions, performed necessary trainings of personnel and audit activities, and implemented the QMS in line with the requirements of GAMP5, Title 21 CFR Part 11, etc.

The following areas were fully covered by procedures and all required supporting documents (templates, forms, checklists, etc.):

  • Development, Product Maintenance Processes,
  • Project Management and Steering,
  • Supply, Configuration and Infrastructure Management,
  • Human Resources Management,
  • Documentation Control,
  • Quality Assurance.

Auditors from a large pharmaceutical company performed three rounds of audit. During these rounds, Formpipe demonstrated continuous improvements in processes and documentation.

 

RESULT

The QMS for Formpipe ECM has successfully passed the audit from a large pharmaceutical company. This enabled the customer to extend their target audience with companies working in pharmaceutical sector. As a result, a new version of ECM system designed for Healthcare market appeared. Sigma Quality Managers continue maintenance of the QMS at Formpipe and support external audits from Healthcare operators.

 

Client: 

Formpipe Software AB is a software company in the field of Enterprise Content Management (ECM). Company products are used by major companies, authorities and organizations

Description: 
Quality Management System corresponding to requirements of Title 21 CFR Part 11 and GAMP5 compliant Healthcare industry operators
Role: 
Joint creation and maintenance of the QMS; support of external compliance audits
Team and Duration: 
3 FTE at development phase and 1 PTE at support stage. Project ongoing for 4+ years
Country: 
Technologies: 
QMS
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