QUMAS helps clients ensure that they are in compliance with the highest regulated standards - to minimize business risk. We offer a full range of validation services within the life sciences industry to companies that are regulated by the FDA and other agencies.
We facilitate compliance and validation with Good Automated Manufacturing Practice (GAMP® http://www.ispe.org/), 21 CFR Part 11, etc. The Food and Drug Administration (FDA) use QUMAS services to reduce time-to-market, enable growth in e-submissions and digital signatures. We help you to address the changing regulatory landscape and gain a competitive advantage.
Because FDA-regulated companies must be compliant through each subsequent release of a product this means that for each hotfix, service pack, and major/minor upgrade, the portion of the system that has changed must be revalidated – often at considerable expense to the regulated organization. QUMAS significantly reduces these costs with its validation scripts created to satisfy GAMP®4 (http://www.ispe.org/) and FDA guidelines. The templates eliminate the need for the clients to write their own while facilitating test and trace requirements. QUMAS support ranges from delivery of the templates and test protocols (many clients prefer to do the PQ piece themselves) to onsite support and management of the validation process. Support is flexible to meet the diverse needs of QUMAS clients and specifically structured to minimize the validation activities associated with future enhancements and configuration changes.
Services are based on the classic V-model and include QUMAS trained validation consultants to assist with any or all of the following activities:
- Validation project management
- Risk analysis
- Validation planning
- Software validation
- IQ/OQ/PQ Protocol development
- Test script authoring; execution, templates
- Creation of a Validation Summary Report
- SOP development
- Regulatory compliance assessments
- Change control
- Validation training
The project schedule, resources equipment and deliverables are presented as part of the project plan, prepared in coordination with the client.
- Significantly reduce validation costs and expedite deployments.
- Minimize the time and cost of validation activities associated with future enhancements and configuration changes.
- Assures compliance with GAMP®(http://www.ispe.org/), cGMPs and the latest developments in 21 CFR 11, including the recent FDA move to a risk-based approach.
A Comprehensive Assessment for the Backup, Restore, Disaster Recovery and Availability of your Mission Critical Data.
Whether caused by a hardware crash, a data center mishap, or even a natural disaster; given time, a system failure will occur in your business…count on it. Having the assurance that the data maintained by your system is effectively backed up and can be made available in an expeditious manner is priceless. QUMAS Systems Continuity Assessment evaluates your company’s ability to maintain continuous access to QUMAS data in the event of a business disruption. It reviews business continuity practices and procedures against common and best practices used by QUMAS customers world-wide.
Top Continuity Challenges
- The establishment of a recovery plan that will meet recovery Service Level Agreements for your Mission Critical QUMAS Solutions.
- Backup windows are increasing as data volumes multiply, causing increasingly long system shutdowns. In the event of an outage, end-users are denied access to critical operational documents.
- Wasted resources backing up data that has not changed since the last backup.
- Heavy reliance on Installation Qualifications and/or Change Order processes to manually restore lost or damaged environments.
- No confidence or vendor certification that existing Backup/Recovery procedures are reliable.
QUMAS Professional Services will work with your Backup, Recovery & Continuity personnel to help address these challenges by analyzing existing backup and recovery environments.
QUMAS will work closely with your team to:
- Ensure efficient and reliable backup and recovery processes that meet required service levels, protect critical business data and improve IT efficiency for your company.
- Remove operational and business risks with faster, more reliable policy-based backup and restores.
- Mitigate unnecessary and/or redundant data.
- Use full back-ups and incremental backups more wisely.
- Free up production system space (Online archiving – note: not full off-line archiving ).
- Reduce overall continuity costs.
- Strengthen ability to manage, automate, and enforce retention policies.
- Increase certainty around the reliability of relevant content retrieval.
QUMAS Professional Services deploys a 3-phased approach for ensuring an effective Continuity Program.
Phase 1 Discovery, Approx 3 days
A QUMAS Backup and Recovery Specialist will gather information about your existing backup and recovery infrastructure, policies, and processes:
- Review existing data backup requirements.
- Review application and data restore requirements/SLA’s.
- Review of backup failure/success history.
- Conduct a comparative analysis of multiple environments (if applicable).
- Determine time required to perform a backup and amount of downtime (if applicable).
- Review staff skill set to identify potential knowledge gaps (particularly when dispersed geographically).
Inventory specific equipment in your backup environment using manual and automated data collection techniques.
Phase 2 Analysis, Approx 3 days
Analyze data from Phase 1.
- Rate of data accumulation/growth and impact on performance/ cost.
- Understand needs of backup information, such as: Legal Discovery, data corruption, hardware failure.
Identify any unconventional performance indicators, configurations, or policies.
Assist in determining the recommended backup configurations and high-level policies.
Final report and executive summary
Phase 3 Findings & Recommendations, Approx 1 day
Present findings in Final Report
Review recommendations for backup configurations, policies, and processes
Identify follow-up steps
- Further, more detailed assessments
- Business impact & justification analysis
- Residency Services
- Near-line back-up strategies