Services
Within the highly regulated pharmaceutical industry compliance is not reserved for the few – it is all encompassing! For these reasons, SOLABS offers a “pure service model” in delivering its Quality Management System (QMS) solutions. This model brings customers the required flexibility to address needs on their terms, taking implementation at their pace and within their scope. SOLABS service engineers will be provided on-site to ensure that implementation is both painless and effective from definition of URS (User Requirement Specifications) to completion of Validation reports (validation package offered by SOLABS).
SOLABS pricing model does not involve user license fees and allows customers to define projects based on URS (User Requirement Specifications) parameters – where the ROI is high and measurable. As an example, you may be facing an issue with your SOP** process and are looking for a solution for that initiative. Although SOLABS has the inherent functionality to handle workflow lifecycles for multiple document types (e.g. validation documentation, study reports, training documentation, master production documentation, etc.), SOLABS would still develop a Year One project proposal and ROI based on your immediate needs for this SOP initiative.
The implementation of SOLABS provides a tool to support growth and search for excellence, while maintaining lean and profitable compliant operations.
The immediate objectives and benefits of this project are:
- Provide a tool to manage documentation (creation, approval, publishing) and reduce work-load related to Document Management;
- Reducing cycle times on processing general GxP documents;
- Possibility to include other events such as Financial events to comply with SOX-alike regulations;
- Eliminate time wasted for information search;
- Reduce (eliminate) human error related to use of wrong information (outdated)
- Provide a tool to reduce cycle time of different business processes, such as Deviations, OOS, CAPA, Change Control, Audits and other Quality Events;
- "On demand audit (internal)": no need to have recurrent audits on documentation. KPI are available always.
- Overall mitigation of non-compliance risk
- Permit e-collaboration in a compliant way and ensure 100% publishing accuracy.
- Generate significant savings on clerical tasks associated to document management and workflow management.
- Adherence to CFR 21, part 11 (ER-ES).
A typical solution delivery agreement involves a three (3) year commitment which includes:
1. Unrestricted use of the SOLABS, level II support (Hot line), upgrades and access to a training environment;
2. An agreed number of days per year in Implementation and Continuous Improvement services - based on the size and anticipated demands of your enterprise.
3. A complete Validation Package, including Validation Master Plan, Installation and operation Qualification protocols(IQ/OQ), Traceability matrix and validation reports.
** Standard Operating Procedure