Consulting

Consulting

RoseTECH Consulting provides consulting services to identify your needs and develop customized, easy-to-implement, user-friendly solutions that positively impact the quality, compliance, and productivity of your organization’s operations.

GLP Start-Up or Transition from R&D to GLP

For organizations transitioning from R&D to GLP or planning to start-up a new GLP facility, RoseTECH specializes in conducting GLP facility audits to evaluate the current status of compliance and identify gaps with GLP regulatory requirements.  An extensive report summarizes findings and recommendations.  We then work with the client to develop a customized GLP Quality System implementation plan to meet the facility’s needs & timeframes.

GLP Quality Systems

We will work with clients to develop a customized GLP implementation plan, including development of SOPs & quality systems (e.g. master schedule, archives, training documentation, equipment qualification).  We provide training to staff to establish GLP roles & responsibility, and identify compliance and regulatory requirements applicable to their intended involvement in GLP operations.

QA Management

RoseTECH provides services for interim QA management.  This may be needed when a new Quality System is being implemented or when the client has an interruption in QA management staffing.

SOP System Development

Standard Operation Procedures are the framework of GLP compliance.   RoseTECH works with the client to develop a customized SOP system.  The SOP system is developed in stages, e.g. general high-level SOPs, general operations SOPs, and detailed specific operations and equipment SOPs.

SOP Writing & Review

RoseTECH has vast experience with writing and review of SOPs.  We work with clients to assure SOPs are clearly written and contain necessary regulatory elements.  We specialize in generating SOPs that are user-friendly and customized to meet the client’s needs to assure that procedures serve the purpose for which they are intended.

GLP Document Templates

We can also develop customized templates for other GLP documents such as training records, CVs, GLP operation forms, data capture forms, protocols, and study reports.

Technical Writing

For studies in which RoseTECH is not involved in QA functions, we also offer technical writing services, such as protocol development and study report writing.