SOLABS QM APPS | Manage Quality Processes | CAPA...

Processes Built for the Life Sciences Industry QM APPS

SOLABS develops APPS to meet your company's individual needs

EQMS Holistic Approach to Quality Processes

SOLABS focuses their efforts on developing a growing library of APPS to manage Quality Processes for the Life Sciences, rather than following a ‘legacy modular approach’. Modules are not user-friendly; they don’t speak to each other, and they require extensive configuration and user training. Unlike modules, QM APPS are linked out of the box with the rest of the SOLABS QM Enterprise Quality Management System (EQMS).
SOLABS QM is composed of 3 main sections: Process (QM APPS), Document and Training. With SOLABS QM and QM APPS, you manage quality processes, controlled documents, and employee training through the same user interface. We like to refer to this as the ‘holistic approach to managing quality operations’.

BLOG: What In The World Are SOLABS QM APPS?



QM APPS Flavors

SOLABS maintains a growing a library of QM APPS in collaboration with industry leaders. The goal is to provide clients with as many APPS as there are needs in the Life Sciences. We encourage potential clients to test drive our APPS before committing to a specific flavor.

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QUALITY EVENTS APPS (Complaints | Deviations | Non-Conformances | Out-of-Specification ) CUSTOMER AUDIT APPS CHANGE CONTROL APPS DOCUMENT CONTROL APPS QM APP CASE STUDIES

CAPA & INVESTIGATION

Corrective Action & Preventive Action (CAPA)

Once the root cause, correction(s), and product impact have been determined and documented in the Quality Event, SOLABS QM can transfer it to the CAPA Process for management of any individual corrective and preventive action (CAPA) required. In this way, the original Quality Event can be closed, and the individual CAPA tracked, closed, and effectiveness checks, if required, performed and documented in the CAPA Process.

SOLABS Quality Mgmt System for Integrated Pharmaceuticals and Contract Medical Manufacturers
Corrective Action Preventative Action Quality Business Process 001 Logo

CAPA | APP-P0013

The CAPA APP-P0013 provides the following capabilities:

QA evaluation is conducted to ensure final QA approval
Further Assignments may involve various stakeholders and/or departments
Risk Assessment and CAPA Categorization add a level of scoped specificity with the aim of better, more targeted solutions
Acceptance of Action Plan is required, in parallel, by departmental stakeholders
A formal QA approval follows before secondary tasks are created/assigned
Users can decide if they’re implementing a voluntary effectiveness check or not, before close-out by QA

SOLABS Quality Management Process P0028 Complaint APP is developed for the needs of companies in the following industries: Contract Manufacturing & Integrated Pharma
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SOLABS QMS for Medical Devices
Corrective Action Preventative Action Quality Business Process 001 Logo

CAPA | APP-P0026

The CAPA APP-P0026 is composed of the following steps:

CAPA Definition, Evaluation and Acceptance take place early: judging the severity of the CAPA is crucial for appropriate follow-through and resolution
Risk Assessment and CAPA Categorization add a level of scoped specificity with the aim of better, more targeted solutions
Extension Requests and Additional Tasks (dependent tasks upon which the completion of the CAPA depends) both appear in this APP
An Effectiveness Check ensures that the preventative action has had measurable and reproducible effects

SOLABS Quality Management Process P0028 Complaint APP is developed for the needs of companies in the following industries: Med Device, Pharmaceutical, Biotechnology, R&D, and Virtual
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SOLABS Quality Management Software for In Vitro Diagnostics
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CAPA | APP-P0030

The CAPA APP-P0030 is composed of the following steps:

CAPA Initiation, Definition and Acceptance provide a well-scoped detailing of corrective/preventative actions proposed
CAPA Completion steps ensure that all are informed about the process and its resulting outcomes
An Effectiveness Check Verification and its accompanying Effectiveness Check Verification Extension Request ensure established, measurable and repeatable outcomes
QA-administered and -tracked Extensions provide tracked flexibility
The ‘looping’ surrounding steps represents both the contractor and the vendor
This looping is well-suited to virtual companies and to those geographically decentralized

SOLABS Quality Management Process P0028 Complaint APP is developed for the needs of companies in the following industries: Med Device, Pharmaceutical, Biotechnology, R&D, and Virtual
View Full Process Flowchart

Investigations

Investigations are often linked to Deviations, Non-Conformances and Complaints. With this in mind, SOLABS QM enables the creation of parent-child relationships between Processes.

QUALITY EVENTS

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Complaints

Management of customer complaints is critical in the Life Sciences as it centralizes client feedback, which can then be fed into adverse event reports. Lot-related information may also be extracted from the ERP system (SAP, for example), or a Complaint Process in SOLABS QM can initiate a CAPA as a dependent child process. Depending on the type of product they develop and/or manufacture, some companies may require a robust Complaint Process to ensure issues are logged, tracked, and thoroughly investigated. Other companies, due to the nature of their business, handle low levels of complaints, and may require a more simple complaint management system.

SOLABS EQMS for Virtual Companies
Complaint QMS Logo P0020

COMPLAINT | APP-P0020

The COMPLAINT APP-P0020 provides the following capabilities:

At any step, the process provides for the notification of customers based on the requirements defined in the Quality Agreements
As many APPS do, this one starts with an electronic business form for entering all information about the complaint such as the source, contact information and nature of it
Field alerts are launched at any point as required
Secondary Tasks that are specific to each complaint may be triggered from any step, if required
If a full investigation is not required, a quality impact summary step is launched

SOLABS Quality Management Process P0020 Complaint APP is developed for the needs of companies in the following industries: Virtual company
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SOLABS EQMS for Virtual Companies
Complaint QMS Pharma, Biotech, Medical Device, Research & Development & Virtual Process 0028 Logo

COMPLAINT | APP-P0028

The COMPLAINT APP-P0028 provides the following capabilities:

The primary intent of this APP is to track complaints across the complexities of outsourced manufacturing and virtual landscapes
QA Assessment helps determine the severity of the Complaint, and triage them
Investigation of Additional Tasks arising as a result of the main investigation, permits users to run tasks until process completion
Extension Requests may be made as required, and administered by QA
A dependent CAPA Process can be launched if this is seen as a requirement
Features have been optimized for this APP that keep clients current with Best Practices

SOLABS Quality Management Process P0028 Complaint APP is developed for the needs of companies in the following industries: Med Device, Pharmaceutical, Biotechnology, R&D, and Virtual
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SOLABS EQMS for Virtual Companies
Complaint QMS Pharma, Biotech, Medical Device, Research & Development & Virtual Process 0028 Logo

COMPLAINT | APP-P0032

The COMPLAINT APP-P0032 provides the following capabilities:

The Complaint is formally received and investigated, with a checklist to address primary concerns
Reporting to Authorities, where required, can be monitored, tracked, and trended to make sure this crucial deadline is not missed
Investigation Review and Approval help tie up any remaining loose ends
The need for Correspondence or standard reply letters is addressed as the Process closes

SOLABS Quality Management Process P0028 Complaint APP is developed for the needs of companies in the following industries: Medical Devices
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Deviations

Deviations can be challenging as they occur in relation to different processes, documents and areas within the organization. Implementing SOLABS QM thus allows each company to harmonize deviation management within a single Process. Our various flavors of Deviation APPS have several levels of complexity to serve the needs of Pharmaceutical manufacturing, R&D and Medical Device companies of different sizes.

SOLABS Quality Mgmt System for Integrated Pharmaceuticals and Contract Medical Manufacturers
Deviation Life Sciences Quality Business Process QMS 0014 Logo

DEVIATION | APP-P0014

The DEVIATION APP-P0014 provides the following capabilities:

During impact/risk assessment, gathered data may support a material disposition
QA may reject/ask for further details to clarify the deviation
At initiation, there are deviation type options: equipment, test methods, validation protocols, etc.
Deviation category can be changed/escalated following investigation
Users can initiate a dependent/related CAPA process where required, before it is closed out by QA

SOLABS EQMS Process P0014 Devition APP is developed for the needs of companies in the following industries: Biotech, Med Device, Pharma, R&D, Virtual
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SOLABS Software for Pharmacuetical Manufact Companies
Deviation Quality Process for Contract Manufacturer Org. (CMOs) & Pharma Logo

DEVIATION | APP-P0027

The DEVIATION APP-P0027 provides the following capabilities:

An Impact Assessment step helps determine how to escalate and proceed
As an outcome of the Impact Assessment, the Investigation is either simply executed, or planned then executed
A dependent CAPA process may be triggered if it is determined to be necessary
Both Extension Requests and Additional Tasks can be leveraged where required
Additional Approvals are processed in parallel, and are linked until all are completed
The Final QA Assessment must be approved by QA
When major Impact Assessment changes are made, the only available action is return to initiator

SOLABS Quality Management Process P0027 Devition APP is developed for the needs of companies in the following industries: Biotech, Med Device, Pharma, R&D, Virtual
View Full Process Flowchart

SOLABS EQMS for Virtual Companies
Deviation Quality Management System Process 002 Logo

DEVIATION | APP-P0031

The DEVIATION APP-P0031 provides the following capabilities:

At any step, the process provides for the notification of customers based on the requirements defined in the Quality Agreements
A simplified and leaner sub-process is available to address minor deviations
In the step called Review for Customer Approval, the customer is to review and approve the investigation and any CAPA identified, if required by the Quality Agreement
Extension of the investigation can be authorized by Quality Assurance only
Critical deviations can easily be escalated to senior management when needed

SOLABS Quality Management Process P0031 Deviation APP is developed for the needs of companies in the following industries: CMO (Contract Manufacturing Organization) & Pharma
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Non-Conformances

At initiation, the Non-Conformance Process is used to record the details of a discrepancy. The Process then goes through an evaluation and an investigation where useful evidence, such as photos or documents, can be attached. Once the steps are completed and approved, the Process is closed and, in some cases, a CAPA Process will be initiated.


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Out-of-Specification (OOS)

Regulations require that investigations be conducted whenever an OOS test result is obtained. It is strongly recommended that an investigation of Out-of-Trend (OOT) test results should also be conducted. Our Out-of-Specification QM APP provides for the investigation of both OOS and OOT test results.

SOLABS EQMS for Research & Development Life Sciences Companies
Document Control Logo for EQMS APP

OOS | APP-P0038

The Out-of-Specification (OOS) APP-P0038 provides the following capabilities:

The process starts with the initiation of a Lab Investigation
As the Investigation Conclusion is reached, both departmental management approval and a QA review are required
The Manufacturing Investigation begins Phase II, in this case with the contract laboratory
Extension Requests provide flexibility, and QA has a final approval
Additional Testing provisions allow for further task steps for unresolved items
The process closes with an interpretation of the investigation results and a release decision

SOLABS QA Process P003 Doc Control APP is developed for the needs of companies in the following industries: MedDevice, Pharmacuetical, Bio, Research and Virtual
View Full Process Flowchart


CUSTOMER AUDIT

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Customer Audit

Companies are frequently audited by customers to whom they supply their GxP materials and services. The Customer Audit Process in SOLABS QM allows companies to automatically manage and document of every step of the customer audit process. The purpose of this Process is to provide the customer with the assurance that their supplier is in compliance with established requirements.

SOLABS Enterprise Software for In Vitro Diagnosis Companies
SOLABS EQMS Business Process P003 Audit APP

AUDIT | APP-P0003

The AUDIT APP-P0003 provides the following capabilities:

Process starts with audit findings, or items to prepare for an upcoming audit
One or more Action Plans are assigned to multiple users, and run in parallel
Each Action Plan, made up of Tasks, can be sent independently for QA Review, and can loop until approved
Users report back with findings, which are submitted independently
Parallel Tasks are assigned to incrementally complete the concluding actions
Audit is linked to Document Control, where you create, approve, and link Audit Agendas, Reports, etc.
Companies can integrate off-site and/or out-of-country consultants, clients, suppliers, etc., with external user accounts

SOLABS EQMS Business Process P003 Audit APP is developed for the needs of companies in the following industries: Medical Device, Pharmaceutical, Biotechnology, Research & Development, and Virtual
View Full Process Overview

SOLABS Enterprise Software for In Vitro Diagnosis Companies
SOLABS EQMS Business Process P003 Audit APP

AUDIT | APP-P0044

The AUDIT APP-P0044 provides the following capabilities:

Process starts with Audit Planning, followed by Audit Preparation and Activities
The preparation and issuance of the Audit Report is followed by Audit Report Responses
Completion of Commitments made as a result of the audit itself
The Audit | APP-P0044 is linked to the Document Control functionality in SOLABS QM, where you can create, review, approve, and link Audit Agendas, Audit Reports, etc.

SOLABS EQMS Business Process P003 Audit APP is developed for the needs of companies in the following industries: Contract Manufacturing Biotechnology & Pharma
View Full Process Overview

CHANGE CONTROL


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Change Control

A successful Change Control Process generally consists of clear responsibilities among initiators, supervisors, coordinators, approvers and those in the Quality Assurance (QA) department. Also important are defined categories and priority levels in a clear and common process.

SOLABS EQMS for Research & Development Life Sciences Companies
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CHANGE CONTROL | APP-P0009

The Change Control APP-P0009 provides the following capabilities:

Various fields may be dynamically updated for management
Selected fields conditionally available and configurable
Regulatory Affairs and department heads may also have parallel tasks/fields
Owners direct Implementation Date and ensure its feasibility
Users verify tasks are appropriately scheduled
When Change Implementation is approved, Regulatory Affairs/Validation approvals are required

SOLABS EQMS Business Process P0016 Change Control APP is developed for the following company types: Contract Manufacturing & Integrated Pharma
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SOLABS EQMS for Research & Development Life Sciences Companies
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CHANGE CONTROL | APP-P0016

The Change Control APP-P0016 provides the following capabilities:

Parallel/multiple tasks are processed in approval pipelines simultaneously
Each pipeline is independent of the others, and can progress unimpeded
A virtual company would be a great fit for this process, or any company requiring approvals from multiple regulators
A Preliminary Regulatory Assessment can occur, with option to return process to Initiator
A Post-QA Pass allows verification that Pre-Implementation tasks are complete

SOLABS EQMS Business Process P0016 Change Control APP is developed for the following company types: Contract Manufacturing, Fully Integrated, Geographically Decentralized, Multiple Foreign Markets, and Virtual
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SOLABS EQMS for Virtual Companies
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CHANGE CONTROL | APP-P0018

The CHANGE CONTROL APP-P0018 provides the following capabilities:

At any step, the process provides for the notification of customers based on the requirements defined in the Quality Agreements
The Supervisor can reject it, if changes to the original request need to be made
The Change Control Coordinator then reviews the request, and assigns approvals on a per-department basis
Departmental approvals are done in parallel for streamlined efficiency
Each department has the option of adding dependent secondary tasks if needed
Before a final QA approval, a regulatory approval step occurs

SOLABS Quality Management Process P0018 Change Control APP is developed for the needs of companies in the following industries: Medical Device and Pharmaceutical manufacturers
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SOLABS EQMS for Contract Manufacting Companies
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CHANGE CONTROL | APP-P0029

The Change Control APP-P0029 provides the following capabilities:

Handles changes initiated by the customer or Contract Manufacturing Organziation (CMO)
Provides steps for the review and approval of each change by the customers impacted and the CMO prior to the change being implemented
Allows the release of product for one customer but not for others
The change control is not closed until all customers have approved the change

SOLABS EQMS Business Process P0029 Change Control APP is developed for the following company types: Contract Manufacturing (CMO) and Pharma
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DOCUMENT CONTROL


SOLABS EQMS for Research & Development Life Sciences Companies
Document Control Logo for EQMS APP

DOCUMENT CONTROL | APP-P0007

The Document Control APP-P0007 provides the following capabilities:

Initiation allows any user to create a Document Control request, based on pre-defined permissions and roles
The two ‘Waiting’ steps allow the SOLABS QM Business Process Engine to verify when pre-specified conditions are met
Outstanding Document Control requests can be obsoleted after a period of time to establish benchmarks and monitor progress
Facilitates volume of work and automation of disparate tasks, standardizes and expedites routine tasks
A Training Completion step ensures user training is complete before a document is made effective

SOLABS QA Process P003 Doc Control APP is developed for the needs of companies in the following industries: MedDevice, Pharmacuetical, Bio, Research and Virtual
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