Compliance

We help healthcare and life sciences companies & institutions understand and navigate the complex transition from a paper-based information environment to a fully automated digital, cloud-based solution. Our best practices are based on FDA 21 CFR Part 11, HIPAA, Health Canada and EU GMP regulations.

Fully Compliant Solutions for Highly Regulated Industries

  • Leveraging the Dot Compliance Suite, built into the fully scalable Salesforce Platform, we provide fully compliant solu- tions and consulting services to ensure healthcare and life sciences companies meet the requirement set out by the Food & Drug Administration, the EU GMP and Health Canada.
  • We have experience helping small, medium and large businesses or practices go paperless in highly regulated indus- tries, from pharmaceuticals to healthcare, medical device companies to hospitals and clinics, as well as legal marijuana producers.
  • The Salesforce Platform is HIPAA and 21 CFR Part 11 compliant.

Process Catalog

Document Management

A Document Management System (DMS) is an electronic solution for drafting, reviewing, approving, tracking and storage of organizational documents...

Training Management

An innovative Learning Management System (LMS) is designed to offer everything from training to record management, to simplify the distribution of courses to employees/students, all done over one network...

Change Management

Change control is a formal process ensuring changes to a product or system are introduced in a controlled, synchronized and well-coordinated manner. Reducing the possibility of unnecessary changes...

Deviation & Nonconformity

Deviation and nonconformity processes are core processes in a quality system. Regulations require organizations to investigate, plan and implement actions in order to find the root cause of an event that’s deviant...

CAPA

Corrective and Preventive Actions (CAPA) improve an organization's implemented processes, eliminating causes of nonconformities or other undesirable outcomes or scenarios...

Supplier Quality Management

Supplier Quality Management is comprised of a set of procedures and processes in the organization's quality systems. Designed to increase the confidence in a supplier's ability to deliver quality goods or services...

Supplier Portal

As the reliance on Contracted Manufacturing Organizations (CMOs), critical suppliers and distribution partners grows, so too does the need to connect quality processes of the entire supply chain...

Patient Safety Tracking

Adverse event reporting and complaint handling processes are designed to ensure that report of potential failure to meet required product quality, safety standards or customer expectations are systematically captured...

Regulatory Affairs

Regulatory affairs processes in our system are designed to ensure compliance of organizations with regulations and laws, while also supporting communication with regulatory agencies and personnel. Registration of products, product variation, and registration...

Batch Production Record

Electronic Batch Record (EBR), also known as Batch Production Record (BPR), or Batch Manufacturing Record (BMR), is the methodology applied to manage and document manufacturing processes in highly regulated industries...

Device History Record

Device History Record, also is known as DHR, is the methodology employed to ensure high quality manufacturing processes in the medical device industry. The DHR process demonstrates how each specific device was manufactured...

Risk Management

The role of Dot Compliance’s Risk/Impact Assessment & Management module is to provide a detailed and systematic appraisal of the potential impacts of an amendment, alteration, or event...

Audit Management

The Dot Compliance Suite Audit Management module helps simplify and organize work and collaboration processes of compiling audits. By ensuring that internal/external audit directives...

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Location

HQ: 78 George St Suite 204 Ottawa, ON K1N 0A8

3 Place Ville Marie Suite 400 Montreal, QC H3B 2E3
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