We deliver SimplerQMS with the following ready-to-use best-practice life science processes, procedures and templates. If you already have a QMS in place, our migration process ensures your move to SimplerQMS.
DOCUMENT & CHANGE CONTROL
Regulatory authorities require that a medical device is safe before bringing it to the market. This requires that medical device companies implement and follow a procedure for design control and create specific records during the development process.
SimplerQMS helps you establish design controls by creating and maintaining:
A Design Control SOP, enforcing learning activities and capturing training records for the employees that need to follow them
Approved templates used for documenting product development
All records and approvals for a specific medical device with versioning, audit trail and electronic signatures
Design History File for each medical device
Single repository for all your drawings, reports, notes and other documents that are created during the design process.
References to documents in the QMS
Controlled access rights
Preparation, review and approval of documents and activities
Medical device companies are required to have a procedure for risk management and maintain risk management documentation for each medical devices based on ISO 14971. SimplerQMS supports all these requirements by:
Creating and maintaining the SOP and ensuring training of employees that need to follow the procedures.
Creating a risk management plan and hazard analysis as part of the design control process.
Recording and assessing risks related to a medical device during product development.
Building a risk management file intended to decrease risks and make the medical device as safe as possible.
SimplerQMS supports life science companies in achieving training compliance by:
Automating generation of training assignments and learning certificates
Building an up-to-date training assignment list for every person.
Once the list is empty, the person is in full training compliance.
Managing essential trainable content, such as SOPs, and learning of that content in one integrated system
Allowing seamless combination of self-learning and train-by-trainer activities
Not only requires that a person learns something once but requires that matching persons hold valid training records at all times
Allow training for people without any login access to SimplerQMS, such as factory workers, suppliers or external personnel
Your company will rely on external suppliers and SimplerQMS can ensure that you have:
Procedures for selecting, evaluating, qualifying and monitoring your suppliers.
An approved supplier list and what they are qualified to deliver.
A repository of files from the suppliers e.g. surveys/evaluations and forms they have filled out and copies of their quality certificates
A set of to-be-conducted audits can be bundled under an Audit Plan.
There’s a predefined set of Audits, each with a slightly different set of metadata.
Recorded issues, such as Audit Findings, NCR’s or complaints, can be recorded at any time, or during an audit event.
A newly identified Risk can be created at any time, or associated with a Risk assessment event, or just a collection of risks about a process.
Based on a recorded issue or an identified risk, any number of both Corrective and Preventive Actions (CAPA) can be generated and assigned for completion.
Documents, Files, Records and Emails can be associated with any Audit, Risk and CAPA as evidence.