Rammell Consulting Limited

Organisational Effectiveness through Records and Information Management
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Projects
Our experience includes the following projects. Please note, this list is not exhaustive. Should you require further information about any of these case studies or require a reference site for our work, please do not hesitate to contact us.
 
Development of a records retention policy 
The client - a small UK-based pharmaceutical company - required us to produce in very short timescales a records retention policy for the whole company. In addition, we also developed a comprehensive records retention schedule using a process-based approach. The schedule covered all areas of drug discovery, development and business administration, including corporate governance. The work was completed in 11 man-days and was implemented within 3 months of project start.

 
Development of file plans
The client - a finance-related department within Central Government - was in the implementation phase of a major Electronic Document Management System in order to comply with the e-Government requirements. Rammell Consulting were employed to develop function-based file plans for the whole organization. These file plans were then used to assist in reorganizing legacy records on distributed project drives before importing them into the new EDMS.
 

 
 
Regulatory expertise
The client - a major multinational pharmaceutical company - had outsourced a project to identify improvements to the clinical trial process. Specifically, it sought to improve the way data and documents were managed. Rammell Consulting were contracted to provide expert regulatory guidance to the project team with respect to records management requirements. This included a review and assessment of worldwide external requirements as well as a review of internal company requirements. All applicable requirements were presented in database format to accompany a written report which included recommended actions for the project team.
 
 
Childcare / Education
Rammell Consulting developed a record retention policy, including a comprehensive retention schedule, for an OFSTED-registered pre-school/childcare centre.

 
Records management strategy planning
Following a series of re-organizations, the client - a major multinational pharmaceutical company - wanted to bring together the various records management functions across the company for a 2-day workshop to prepare a five-year strategic framework for records management. In consultation with the global records management champion, Rammell Consulting designed the workshop and facilitated the meeting. This allowed the workshop chairman to act independently from internal politics and any personal agendas or history that may have been present. It also allowed all attendees to participate fully in the workshop
 
Process development
Rammell Consulting assisted a multinational pharmaceutical company with the development of improved records management and filing processes when interacting with contract research organizations. Historically, processes were either not discussed or were agreed in an ad hoc manner, often with no involvement of records management professionals. Rammell Consulting developed a series of proposals for the client for process improvement which would result in better, consistent practices being followed when working with CROs.
 
 
 
Records management audit / review
We were asked by a biotechnology R&D company to conduct a records audit of their organisation. The audit included a detailed inspection of their clinical trial master files in readiness for an expected MHRA inspection. In addition, a comprehensive audit was conducted of the records management infrastructure within the company. This included aspects such as availability of retention schedules, records policies and procedures (SOPs), a vital records programme and monitoring and auditing procedures. Rammell Consulting then assisted the client to implement the recommended corrective actions.
 
 
Records retention requirements
The client was involved in an established project to rationalise its records and data repositories, thereby reducing their IT cost overheads. As a key part of this project, Rammell Consulting were asked to review all applicable worldwide regulations that pertained to records and data in those repositories. We were asked to make records retention recommendations that would enable the records and data to be managed more cost effectively, yet remaining compliant with applicable regulatory obligations.
 
 
Use of off-site commercial storage providers
It is becoming much more common to see companies storing their vital business records with commercial storage companies rather than housing these in on-site facilities. It is essential however to ensure that these facilities meet applicable requirements and just as important, that the contracts and service level agreements include the necessary clauses to maintain continued compliance withh all pertinent regulations. Rammell Consulting has reviewed existing storage contracts for a client, recommending amendments to the text to ensure compliance with industry best practice and with relevant UK Statutory Instruments. We also worked with another client to select a new storage provider, creating a short-list, conducting pre-selection audits of three potential vendors and developing a robust contract with the chosen storage company.