BioPharma Services enhances systems with new Quality Management solution

BioPharma Services is proud to announce that the Dot Compliance suite, a cloud based highly secure Quality Management System (eQMS) solution for life science companies powered by the Salesforce platform, has now been integrated. Salesforce is the leading platform for enterprise SAAS applications in the life sciences industry and Dot Compliance is an OEM solution based on Salesforce standard methods, allowing greater flexibility, consistent user experience, operational efficiency, tight security standards and scalability.

The eQMS is a formal system for documenting processes, procedures and responsibilities within BioPharma to achieve a quality objective and meet regulatory requirements.This cloud based eQMS solution will ensure a dramatic shift in the way BioPharma runs our business and will further enhance the culture of quality that is embodied throughout the organisation.

Regulatory Standards

The Dot Compliance eQMS is compliant with regulatory standards such as CFR Part 11 and EU Annex 11 and supports ISO 9001, ISO13485:2016, ISO 14791 and ISO 27001.

eQMS Modules

The eQMS core quality processes (modules) are essential for our ever growing organisation.

• • Training Management  (launched June 18, 2021)
  • Document Management (launched Aug 18, 2021)
  • Deviations / Non-conformances
  • CAPA Management
  • Audit Management
  • Complaint Management
  • Change Control
  • Risk Assessment
  • Supplier Quality

Digitalizing our Quality Management System will streamline and enhance BioPharma workflows, customer base and workforce.

About BioPharma Services Inc.

BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing.

To book a virtual discovery session with our experts, click here